Intermittent Claudication, Peripheral Arterial Disease
Conditions
Keywords
Exercise, High-intensity interval training, interval training
Brief summary
This INITIATE study evaluates the use of high-intensity interval training as a treatment modality for patients with intermittent claudication - an ambulatory leg pain caused by narrowed arteries that supply the lower limbs. It is an observational cohort study considering high-intensity interval training (HIIT) as a treatment for intermittent claudication, consisting of two workstreams. Workstream 1: an initial observational cohort study to consider the feasibility of the intervention and exclusion criteria. Workstream 2: a proof of concept study utilising the altered intervention and exclusion criteria following recommendations highlighted during workstream 1.
Detailed description
Patients with peripheral vascular disease (PVD) may develop a reproducible pain in their legs when they walk, which usually subsides with rest. This is known as intermittent claudication (IC) and is caused by a reduced blood supply to the legs as a result of narrowed or hardened arteries that supply the lower limbs. This ambulatory pain impedes on activities of daily living, functional capacity and quality of life. National Institute for Health and Care Excellence (NICE) clinical guidance recommends a 12-week supervised exercise programme as first-line treatment for IC, whereby patients are encouraged to walk to the point of maximal pain. Robust clinical trials have demonstrated that supervised exercise programmes are efficacious for improving both pain-free and maximal walking distances, whilst also potentially improving quality of life. Despite this, supervised exercise programmes are vastly under-utilised and not always available to consultant vascular surgeons. This means that further programmes need to be developed in order to provide a range of options to patients to improve uptake and adherence rates. One such programme is a 6-week high-intensity interval training programme. An initial observational cohort study of the 6 week HIIT programme will be conducted to determine to determine the feasibility of the intervention and inclusion criteria. The results from this will be used to make any necessary changes to the HIIT intervention before moving into a proof of concept study, considering the utility, safety, acceptability and potential clinical efficacy of this programme.
Interventions
OTHERHigh-intensity interval training
a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike.
Sponsors
University of Hull
Hull University Teaching Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Workstream 1: An initial single group cohort of 30 patients will be recruited and analysed to refine/alter the intervention and exclusion criteria based on its feasibility. Workstream 2: This altered intervention and inclusion criteria will be considered in a further proof of concept study which will be multi-centre aiming to recruit a further x40 patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Workstream 1 Inclusion criteria: * Aged \>18 years * Ankle-brachial pressure index (ABPI) \<0.9 at rest or a systolic pressure drop of ≥20mmHg at the ankle after exercise testing * Ability to walk unaided * English speaking and able to comply with exercise instructions
Exclusion criteria
* Unable to provide informed consent * Critical limb threatening ischaemia / rest pain / tissue loss * Active cancer treatment * Significant comorbidities precluding safe participation in exercise testing and / or training according to the American College of Sports Medicine (ACSM) guidelines (28) * Resting/uncontrolled tachycardia (\>100 beats per minute \[bpm\]) and/or resting/uncontrolled hypertension (systolic blood pressure \>180 millimetres of mercury \[mmHg\] or diastolic blood pressure \>100mmHg) * Symptomatic hypotension Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Test - Related Withdrawals | From the first to last exercise session, i.e. from week 0 to week 6. | Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate). |
| Feasibility Test | From study opening to completion/withdrawal of the last patient | Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed. |
| Tolerability Test - Achieving the Required Intensity | From the first to last exercise session, i.e. from week 0 to week 6. | Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session |
| Tolerability Test - Number of Sessions Completed | From the first to last exercise session, i.e. from week 0 to week 6. | Considers the number of sessions completed compared to the theoretical number. |
| Tolerability Test - Number of HIIT Intervals Completed | From the first to last exercise session, i.e. from week 0 to week 6. | Considers the number of HIIT intervals completed compared to the theoretical number. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Quality of Life Questionnaire - (VascuQol) | Baseline and post-intervention (week 6) follow-up | VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best. |
| Ankle-Brachial Pressure Index | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | The index or ratio of the pressure in the ankle compared with the arm. |
| Safety Events Recorded | From enrolment to completion of 12-week follow-up | Defined as the occurrence of any adverse or serious adverse events related to the intervention. |
| Pain-free Walking Distance | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | assessment of the distance that the patient can currently walk before experiencing claudication pain. |
| Ventilatory Anaerobic Threshold (VAT) | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing |
| Peak Power Output | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | Peak power output assessed via CPET |
| Acceptability Testing | post-intervention follow-up, i.e. week 6. | An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews. |
| Maximum Walking Distance | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | assessment of the distance that the patient can currently walk before having to stop due to claudication pain. |
| Peak Oxygen Uptake | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. | Peak oxygen uptake assessed via cardiopulmonary exercise testing |
| Quality of Life Questionnaire Short-form-36 (SF-36) | Baseline and post-intervention (week 6) | Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High-Intensity Interval Training (Workstream 1) High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate. | 30 |
| High-Intensity Interval Training (Workstream 2) High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate | 40 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Abnormal cardiopulmonary exercise test (CPET) or unable to achieve a maximal test | 9 |
| Overall Study | Adverse Event | 2 |
| Overall Study | Concurrent illness | 2 |
| Overall Study | No longer meeting inclusion criteria | 2 |
| Overall Study | No reason given | 1 |
| Overall Study | Unable to tolerate | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Total | High-Intensity Interval Training (Workstream 1) | High-Intensity Interval Training (Workstream 2) |
|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 9 | 69 years STANDARD_DEVIATION 9 | 69 years STANDARD_DEVIATION 8 |
| Ankle-brachial pressure index (ABPI) (worst leg) | 0.63 Index STANDARD_DEVIATION 0.21 | 0.64 Index STANDARD_DEVIATION 0.2 | 0.63 Index STANDARD_DEVIATION 0.21 |
| Best medical therapy (BMT) | 56 Participants | 26 Participants | 30 Participants |
| body mass index (BMI) | 28.2 kg/m^2 STANDARD_DEVIATION 3.9 | 28.5 kg/m^2 STANDARD_DEVIATION 4 | 28.0 kg/m^2 STANDARD_DEVIATION 3.9 |
| Diastolic blood pressure | 80 mmHg STANDARD_DEVIATION 11 | 79 mmHg STANDARD_DEVIATION 8 | 81 mmHg STANDARD_DEVIATION 13 |
| Height | 168.7 cm STANDARD_DEVIATION 8.3 | 168.5 cm STANDARD_DEVIATION 7.2 | 169.1 cm STANDARD_DEVIATION 10 |
| Intermittent claudication distance (ICD) | 125.1 metres STANDARD_DEVIATION 97.9 | 118.6 metres STANDARD_DEVIATION 109.9 | 130.2 metres STANDARD_DEVIATION 88.8 |
| Maximum Walking Distance (MWD) | 307.9 metres STANDARD_DEVIATION 199.6 | 283 metres STANDARD_DEVIATION 190.5 | 327.5 metres STANDARD_DEVIATION 206.8 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 12 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 58 Participants | 23 Participants | 35 Participants |
| Smoking status Current | 24 Participants | 11 Participants | 13 Participants |
| Smoking status Ex | 39 Participants | 17 Participants | 22 Participants |
| Smoking status Non-smoker | 7 Participants | 2 Participants | 5 Participants |
| Systolic blood pressure | 146 mmHg STANDARD_DEVIATION 19 | 146 mmHg STANDARD_DEVIATION 20 | 146 mmHg STANDARD_DEVIATION 20 |
| Weight | 80.6 kg STANDARD_DEVIATION 15.2 | 81.6 kg STANDARD_DEVIATION 16.2 | 79.9 kg STANDARD_DEVIATION 14.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 10 / 70 |
| serious Total, serious adverse events | 1 / 70 |
Outcome results
Primary
Feasibility Test
Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed.
Time frame: From study opening to completion/withdrawal of the last patient
Population: The overall number of participants analysed in the number of patients screened. Each row then represents the number of patients eligible vs. screened, the number recruited vs. eligible and the number completed vs. recruited.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-Intensity Interval Training | Feasibility Test | Workstream 2 - eligible | 165 participants |
| High-Intensity Interval Training | Feasibility Test | Workstream 2 - recruited | 40 participants |
| High-Intensity Interval Training | Feasibility Test | Workstream 2 - completed | 31 participants |
| High-Intensity Interval Training | Feasibility Test | Workstream 1 - screened | 144 participants |
| High-Intensity Interval Training | Feasibility Test | Workstream 1 - eligible | 95 participants |
| High-Intensity Interval Training | Feasibility Test | Workstream 1 - recruited | 30 participants |
| High-Intensity Interval Training | Feasibility Test | Workstream 1 - completed | 15 participants |
| High-Intensity Interval Training | Feasibility Test | Workstream 2 - screened | 280 participants |
Primary
Tolerability Test - Achieving the Required Intensity
Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Population: Includes all participants that completed the programme and the type of units is the number of HIIT intervals completed. The number analysed is the total amount of intervals completed per workstream. The count of units is the number of intervals where the required intensity was achieved.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| High-Intensity Interval Training | Tolerability Test - Achieving the Required Intensity | Workstream 1 - intervals at the required intensity | 2210 Number of HIIT intervals |
| High-Intensity Interval Training | Tolerability Test - Achieving the Required Intensity | Workstream 2 - intervals at the required intensity | 4546 Number of HIIT intervals |
Primary
Tolerability Test - Number of HIIT Intervals Completed
Considers the number of HIIT intervals completed compared to the theoretical number.
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Population: Includes all participants that completed the programme and the type of units is the number of HIIT intervals completed. The number analysed is the total amount of planned HIIT intervals. The count of units is the number of intervals that were actually completed.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| High-Intensity Interval Training | Tolerability Test - Number of HIIT Intervals Completed | Workstream 1 - HIIT intervals completed | 234 Number of HIIT intervals |
| High-Intensity Interval Training | Tolerability Test - Number of HIIT Intervals Completed | Workstream 2 - HIIT intervals completed | 475 Number of HIIT intervals |
Primary
Tolerability Test - Number of Sessions Completed
Considers the number of sessions completed compared to the theoretical number.
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Population: Includes all participants that completed the programme and the type of units is the number of HIIT sessions completed. The number analysed is the total amount of planned sessions per workstream. The count of units is the number of sessions that were actually attended.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| High-Intensity Interval Training | Tolerability Test - Number of Sessions Completed | Workstream 1 - HIIT sessions completed | 270 Number of HIIT sessions |
| High-Intensity Interval Training | Tolerability Test - Number of Sessions Completed | Workstream 2 - HIIT sessions completed | 551 Number of HIIT sessions |
Primary
Tolerability Test - Related Withdrawals
Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Population: Workstream 1 = 30 participants Workstream 2 = 40 participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-Intensity Interval Training | Tolerability Test - Related Withdrawals | Workstream 1 - unable to tolerate HIIT or CPEX | 1 Participants |
| High-Intensity Interval Training | Tolerability Test - Related Withdrawals | Workstream 2 - unable to tolerate HIIT or CPEX | 3 Participants |
Secondary
Acceptability Testing
An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
Time frame: post-intervention follow-up, i.e. week 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-Intensity Interval Training | Acceptability Testing | 23 Participants |
Secondary
Ankle-Brachial Pressure Index
The index or ratio of the pressure in the ankle compared with the arm.
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises:~Post-intervention follow-up Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 44/70.~4-week post-intervention follow-up Workstream 1; n = 12/30 Workstream 2; n = 16/40 Total = 28/70.~12-week post-intervention follow-up Workstream 1; n =11/30 Workstream 2; n = 24/40 Total = 35/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Ankle-Brachial Pressure Index | Workstream 1 baseline | 0.76 Index | Standard Deviation 0.22 |
| High-Intensity Interval Training | Ankle-Brachial Pressure Index | Workstream 1 post- intervention follow-up | 0.78 Index | Standard Deviation 0.19 |
| High-Intensity Interval Training | Ankle-Brachial Pressure Index | Workstream 1 - 4-week post-intervention follow-up | 0.74 Index | Standard Deviation 0.2 |
| High-Intensity Interval Training | Ankle-Brachial Pressure Index | Workstream 1 - 12-week post-intervention follow-up | 0.80 Index | Standard Deviation 0.2 |
| High-Intensity Interval Training | Ankle-Brachial Pressure Index | Workstream 2 baseline | 0.74 Index | Standard Deviation 0.19 |
| High-Intensity Interval Training | Ankle-Brachial Pressure Index | Workstream 2 post-intervention follow-up | 0.76 Index | Standard Deviation 0.14 |
| High-Intensity Interval Training | Ankle-Brachial Pressure Index | Workstream 2 - 4-week post-intervention follow-up | 0.78 Index | Standard Deviation 0.12 |
| High-Intensity Interval Training | Ankle-Brachial Pressure Index | Workstream 2 - 12-week post-intervention follow-up | 0.74 Index | Standard Deviation 0.14 |
Secondary
Maximum Walking Distance
assessment of the distance that the patient can currently walk before having to stop due to claudication pain.
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises:~Post-intervention follow-up Workstream 1; n = 15/30 Workstream 2; n = 29/40 Total = 44/70.~4-week post-intervention follow-up Workstream 1; n = 12/30 Workstream 2; n = 16/40 Total = 28/70.~12-week post-intervention follow-up Workstream 1; n =11/30 Workstream 2; n = 24/40 Total = 35/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Maximum Walking Distance | Workstream 1 baseline | 243.8 metres | Standard Deviation 102.2 |
| High-Intensity Interval Training | Maximum Walking Distance | Workstream 1 Post-intervention follow-up | 365.2 metres | Standard Deviation 153.6 |
| High-Intensity Interval Training | Maximum Walking Distance | Workstream 1 - 4-week post intervention follow-up | 365.4 metres | Standard Deviation 172.3 |
| High-Intensity Interval Training | Maximum Walking Distance | Workstream 1 - 12-week post intervention follow-up | 374.2 metres | Standard Deviation 233.4 |
| High-Intensity Interval Training | Maximum Walking Distance | Workstream 2 baseline | 366.5 metres | Standard Deviation 201 |
| High-Intensity Interval Training | Maximum Walking Distance | Workstream 2 Post-intervention follow-up | 455.0 metres | Standard Deviation 220.8 |
| High-Intensity Interval Training | Maximum Walking Distance | Workstream 2 - 4-week post intervention follow-up | 450.7 metres | Standard Deviation 242.8 |
| High-Intensity Interval Training | Maximum Walking Distance | Workstream 2 - 12-week post intervention follow-up | 448.1 metres | Standard Deviation 240.9 |
Secondary
Pain-free Walking Distance
assessment of the distance that the patient can currently walk before experiencing claudication pain.
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises:~Post-intervention follow-up Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 45/70.~4-week post-intervention follow-up Workstream 1; n = 12/30 Workstream 2; n = 16/40 Total = 28/70.~12-week post-intervention follow-up Workstream 1; n =11/30 Workstream 2; n = 24/40 Total = 35/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Pain-free Walking Distance | Workstream 1 baseline | 114.1 metres | Standard Deviation 75.4 |
| High-Intensity Interval Training | Pain-free Walking Distance | Workstream 1 Post-intervention follow-up | 141.3 metres | Standard Deviation 62.4 |
| High-Intensity Interval Training | Pain-free Walking Distance | Workstream 1 - 4-week post intervention follow-up | 172.4 metres | Standard Deviation 103.5 |
| High-Intensity Interval Training | Pain-free Walking Distance | Workstream 1 - 12-week post intervention follow-up | 216.3 metres | Standard Deviation 163.2 |
| High-Intensity Interval Training | Pain-free Walking Distance | Workstream 2 baseline | 142.5 metres | Standard Deviation 95.5 |
| High-Intensity Interval Training | Pain-free Walking Distance | Workstream 2 Post-intervention follow-up | 218.6 metres | Standard Deviation 166.6 |
| High-Intensity Interval Training | Pain-free Walking Distance | Workstream 2 - 4-week post intervention follow-up | 212.7 metres | Standard Deviation 173.8 |
| High-Intensity Interval Training | Pain-free Walking Distance | Workstream 2 - 12-week post intervention follow-up | 276.0 metres | Standard Deviation 214.7 |
Secondary
Peak Oxygen Uptake
Peak oxygen uptake assessed via cardiopulmonary exercise testing
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises:~End of programme follow-up:~Workstream 1; n = 13/30 Workstream 2; n = 29/40 Total = 42/70.~4-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 16/40 Total = 26/70.~12-week follow-up: Workstream 1; n = 9/30 Workstream 2; n = 20/40 Total = 29/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Peak Oxygen Uptake | Workstream 1 - baseline VO2Peak | 15.4 ml/kg/min | Standard Deviation 2.8 |
| High-Intensity Interval Training | Peak Oxygen Uptake | Workstream 1 - post-intervention follow-up VO2Peak | 15.9 ml/kg/min | Standard Deviation 3 |
| High-Intensity Interval Training | Peak Oxygen Uptake | Workstream 1 - 4-week post-intervention follow-up VO2Peak | 15.8 ml/kg/min | Standard Deviation 2.3 |
| High-Intensity Interval Training | Peak Oxygen Uptake | Workstream 1 - 12-week post-intervention follow-up VO2Peak | 15.3 ml/kg/min | Standard Deviation 3.1 |
| High-Intensity Interval Training | Peak Oxygen Uptake | Workstream 2 - baseline VO2Peak | 16.4 ml/kg/min | Standard Deviation 3.9 |
| High-Intensity Interval Training | Peak Oxygen Uptake | Workstream 2 - post-intervention follow-up VO2Peak | 17.1 ml/kg/min | Standard Deviation 4.3 |
| High-Intensity Interval Training | Peak Oxygen Uptake | Workstream 2 - 4-week post-intervention follow-up VO2Peak | 16.9 ml/kg/min | Standard Deviation 4.6 |
| High-Intensity Interval Training | Peak Oxygen Uptake | Workstream 2 - 12-week post-intervention follow-up VO2Peak | 17.8 ml/kg/min | Standard Deviation 4.1 |
Secondary
Peak Power Output
Peak power output assessed via CPET
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises:~End of programme follow-up:~Workstream 1; n = 13/30 Workstream 2; n = 29/40 Total = 42/70.~4-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 16/40 Total = 26/70.~12-week follow-up: Workstream 1; n = 9/30 Workstream 2; n = 20/40 Total = 29/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Peak Power Output | Workstream 1 - baseline peak power output | 94.9 Watts | Standard Deviation 26.1 |
| High-Intensity Interval Training | Peak Power Output | Workstream - 1 post-intervention peak power output | 103.7 Watts | Standard Deviation 30.4 |
| High-Intensity Interval Training | Peak Power Output | Workstream 1 - 4-weeks post-intervention follow-up peak power output | 98.7 Watts | Standard Deviation 23.4 |
| High-Intensity Interval Training | Peak Power Output | Workstream 1 - 12-week post-intervention follow-up peak power output | 102.7 Watts | Standard Deviation 30.8 |
| High-Intensity Interval Training | Peak Power Output | Workstream 2 - baseline peak power output | 101.6 Watts | Standard Deviation 39.4 |
| High-Intensity Interval Training | Peak Power Output | Workstream 2 - post-intervention follow-up peak power output | 106.0 Watts | Standard Deviation 43 |
| High-Intensity Interval Training | Peak Power Output | Workstream 2 - 4-weeks post-intervention follow-up peak power output | 112.0 Watts | Standard Deviation 44.5 |
| High-Intensity Interval Training | Peak Power Output | Workstream 2 - 12-weeks post-intervention follow-up peak power output | 114.1 Watts | Standard Deviation 45.5 |
Secondary
Quality of Life Questionnaire Short-form-36 (SF-36)
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time frame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention
Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises:~4-week follow-up: Workstream 1; n = 13/30 Workstream 2; n = 16/40 Total = 29/70.~12-week follow-up: Workstream 1; n = 11/30 Workstream 2; n = 24/40 Total = 35/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4-week follow-up vitality | 51.0 units on a scale | Standard Deviation 17.5 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up vitality | 55.1 units on a scale | Standard Deviation 7.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up social functioning | 85.0 units on a scale | Standard Deviation 17.5 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 4-week follow-up general health | 54.6 units on a scale | Standard Deviation 18.1 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12-week follow-up general health | 53.2 units on a scale | Standard Deviation 19.5 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4-week follow-up physical functioning | 61.9 units on a scale | Standard Deviation 20.1 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up physical functioning | 64.1 units on a scale | Standard Deviation 20.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4-week follow-up role physical | 61.5 units on a scale | Standard Deviation 30.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up follow-up role physical | 62.5 units on a scale | Standard Deviation 26.8 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4-week follow-up pain | 53.2 units on a scale | Standard Deviation 19.6 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up pain | 54.1 units on a scale | Standard Deviation 24.7 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4-week follow-up general health | 47.4 units on a scale | Standard Deviation 13.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up general health | 53.5 units on a scale | Standard Deviation 19.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4-week follow-up social functioning | 84.6 units on a scale | Standard Deviation 20.5 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4-week follow-up role emotional | 80.8 units on a scale | Standard Deviation 31.6 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up role emotional | 76.5 units on a scale | Standard Deviation 23.8 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4-week follow-up mental health | 71.2 units on a scale | Standard Deviation 15.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up mental health | 71.8 units on a scale | Standard Deviation 15.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4-week follow-up PCS | 40.9 units on a scale | Standard Deviation 8.4 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up PCS | 38.8 units on a scale | Standard Deviation 15.4 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 4 week follow-up MCS | 51.5 units on a scale | Standard Deviation 9.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 - 12-week follow-up MCS | 46.8 units on a scale | Standard Deviation 17.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 4-week follow-up physical functioning | 61.7 units on a scale | Standard Deviation 19.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12-week follow-up physical functioning | 61.5 units on a scale | Standard Deviation 20.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 4-week follow-up role physical | 63.9 units on a scale | Standard Deviation 24.5 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12-week follow-up role physical | 57.3 units on a scale | Standard Deviation 23.4 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 4-week pain | 55.6 units on a scale | Standard Deviation 20.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12-week follow-up pain | 57.5 units on a scale | Standard Deviation 23.6 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 4-week follow-up vitality | 54.9 units on a scale | Standard Deviation 20.7 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12 -week follow-up vitality | 54.8 units on a scale | Standard Deviation 22 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 4-week follow-up social functioning | 79.9 units on a scale | Standard Deviation 25.4 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12-week follow-up social functioning | 76.5 units on a scale | Standard Deviation 27.8 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 4-week follow-up role emotional | 77.3 units on a scale | Standard Deviation 26.5 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12-week follow-up role emotional | 77.7 units on a scale | Standard Deviation 26.5 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 4-week follow-up mental health | 78.9 units on a scale | Standard Deviation 17.4 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12-week follow-up mental health | 78.0 units on a scale | Standard Deviation 18.6 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 4-week follow-up PCS | 41.7 units on a scale | Standard Deviation 7.5 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12-week follow-up PCS | 41.0 units on a scale | Standard Deviation 8.6 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 4-week follow-up MCS | 52.5 units on a scale | Standard Deviation 10 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 - 12-week follow-up MCS | 52.3 units on a scale | Standard Deviation 11.2 |
Secondary
Quality of Life Questionnaire Short-form-36 (SF-36)
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time frame: Baseline and post-intervention (week 6)
Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises:~Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 45/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline general health | 46.6 units on a scale | Standard Deviation 19.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline pain | 47.3 units on a scale | Standard Deviation 19.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline MCS | 52.3 units on a scale | Standard Deviation 8.8 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline physical functioning | 50.1 units on a scale | Standard Deviation 18.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up physical functioning | 54.7 units on a scale | Standard Deviation 20.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline role physical | 52.5 units on a scale | Standard Deviation 26.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up role physical | 55.4 units on a scale | Standard Deviation 27.7 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline pain | 47.9 units on a scale | Standard Deviation 13.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up pain | 50.0 units on a scale | Standard Deviation 22.6 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up general health | 52.7 units on a scale | Standard Deviation 20.8 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline vitality | 41.5 units on a scale | Standard Deviation 15.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up vitality | 50.9 units on a scale | Standard Deviation 17.4 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline social functioning | 76.8 units on a scale | Standard Deviation 26.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up social functioning | 76.8 units on a scale | Standard Deviation 27.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline role emotional | 73.3 units on a scale | Standard Deviation 30.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up role emotional | 80.0 units on a scale | Standard Deviation 25.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline mental health | 68.6 units on a scale | Standard Deviation 17.7 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up mental health | 73.6 units on a scale | Standard Deviation 17.8 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline PCS | 37.8 units on a scale | Standard Deviation 7.6 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up PCS | 39.4 units on a scale | Standard Deviation 7.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 baseline MCS | 49.2 units on a scale | Standard Deviation 9.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 1 follow-up MCS | 51.9 units on a scale | Standard Deviation 9.4 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline physical functioning | 53.3 units on a scale | Standard Deviation 19.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up physical functioning | 56.2 units on a scale | Standard Deviation 19.1 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline role physical | 52.9 units on a scale | Standard Deviation 23.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up role physical | 60.8 units on a scale | Standard Deviation 24.7 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up pain | 54.1 units on a scale | Standard Deviation 22.6 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline general health | 54.4 units on a scale | Standard Deviation 21.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up general health | 54.8 units on a scale | Standard Deviation 19.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline vitality | 53.2 units on a scale | Standard Deviation 17.8 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up vitality | 55.8 units on a scale | Standard Deviation 19.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline social functioning | 77.5 units on a scale | Standard Deviation 24.7 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up social functioning | 75.4 units on a scale | Standard Deviation 27.9 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline role emotional | 73.1 units on a scale | Standard Deviation 25.2 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up role emotional | 75.6 units on a scale | Standard Deviation 25.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline mental health | 76.7 units on a scale | Standard Deviation 14.5 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up mental health | 76.7 units on a scale | Standard Deviation 19.8 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 baseline PCS | 38.5 units on a scale | Standard Deviation 7 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up PCS | 40.7 units on a scale | Standard Deviation 7.3 |
| High-Intensity Interval Training | Quality of Life Questionnaire Short-form-36 (SF-36) | Workstream 2 follow-up MCS | 52 units on a scale | Standard Deviation 10.4 |
Secondary
Safety Events Recorded
Defined as the occurrence of any adverse or serious adverse events related to the intervention.
Time frame: From enrolment to completion of 12-week follow-up
Population: The analysed population is all patients who were recruited to the programme. Adverse events were considered at each visit and exercise session.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-Intensity Interval Training | Safety Events Recorded | Workstream 1 | 3 Events |
| High-Intensity Interval Training | Safety Events Recorded | Workstream 2 | 9 Events |
Secondary
Vascular Quality of Life Questionnaire - (VascuQol)
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Time frame: Baseline and post-intervention (week 6) follow-up
Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises:~Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 45/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 baseline pain score | 4.2 units on a scale | Standard Deviation 1.3 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 follow-up pain score | 4.4 units on a scale | Standard Deviation 1.5 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 baseline social score | 5.5 units on a scale | Standard Deviation 1.7 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 follow-up social score | 5.7 units on a scale | Standard Deviation 1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 baseline activities score | 4.4 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 follow-up activities score | 4.6 units on a scale | Standard Deviation 1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 baseline symptom score | 5.5 units on a scale | Standard Deviation 0.6 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 follow-up symptom score | 5.8 units on a scale | Standard Deviation 0.6 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 baseline emotional score | 5.4 units on a scale | Standard Deviation 1.6 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 follow-up emotional score | 5.4 units on a scale | Standard Deviation 1.4 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 baseline total score | 4.9 units on a scale | Standard Deviation 1.1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 follow-up total score | 5.1 units on a scale | Standard Deviation 1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 baseline pain score | 3.7 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 follow-up pain score | 4.5 units on a scale | Standard Deviation 1.1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 baseline social score | 5.2 units on a scale | Standard Deviation 1.7 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 follow-up social score | 5.4 units on a scale | Standard Deviation 1.8 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 baseline activities score | 4.3 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 follow-up activities score | 4.7 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 baseline symptom score | 4.9 units on a scale | Standard Deviation 1.3 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 follow-up symptom score | 5.4 units on a scale | Standard Deviation 1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 baseline emotional score | 5.2 units on a scale | Standard Deviation 1.3 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 follow-up emotional score | 5.5 units on a scale | Standard Deviation 1.4 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 baseline total score | 4.6 units on a scale | Standard Deviation 1.1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 follow-up total score | 5.0 units on a scale | Standard Deviation 1.1 |
Secondary
Vascular Quality of Life Questionnaire - (VascuQol)
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Time frame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Population: Only patients completing the programme and providing follow-up data are included. This comprises:~4-week follow-up: Workstream 1; n = 13/30 Workstream 2; n = 16/40 Total = 29/70. 12-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 24/40 Total = 34/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 4-week follow-up social score | 6.3 units on a scale | Standard Deviation 1.1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 - 4-week follow-up social score | 5.5 units on a scale | Standard Deviation 1.6 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 4-week follow-up pain score | 4.7 units on a scale | Standard Deviation 1.7 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 -12-week follow-up pain score | 5.4 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 12-week follow-up social score | 6.4 units on a scale | Standard Deviation 0.9 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 4-week follow-up activities score | 5.2 units on a scale | Standard Deviation 1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 12-week follow-up activities score | 5.2 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 4-week follow-up symptom score | 5.8 units on a scale | Standard Deviation 0.6 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 12-week follow-up symptom score | 5.9 units on a scale | Standard Deviation 0.7 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 4-week follow-up emotional score | 6.0 units on a scale | Standard Deviation 1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 12-week follow-up emotional score | 6.4 units on a scale | Standard Deviation 0.4 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 4-week total score | 5.6 units on a scale | Standard Deviation 1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 1 - 12-week follow-up total score | 5.8 units on a scale | Standard Deviation 0.7 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 4-week follow-up pain score | 4.8 units on a scale | Standard Deviation 1.3 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 - 12-week follow-up pain score | 4.6 units on a scale | Standard Deviation 1.3 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 - 12-week follow-up social score | 5.4 units on a scale | Standard Deviation 1.7 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 4-week follow-up activities score | 4.9 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 - 12-week follow-up activities score | 4.7 units on a scale | Standard Deviation 1.1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 4-week follow-up symptom score | 5.3 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 - 12-week follow-up symptom score | 5.2 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 4-week follow-up emotional score | 5.7 units on a scale | Standard Deviation 1.3 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 - 12-week follow-up emotional score | 5.5 units on a scale | Standard Deviation 1.1 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 - 4-week follow-up total score | 5.2 units on a scale | Standard Deviation 1.2 |
| High-Intensity Interval Training | Vascular Quality of Life Questionnaire - (VascuQol) | Workstream 2 - 12-week follow-up total score | 5.0 units on a scale | Standard Deviation 1.1 |
Secondary
Ventilatory Anaerobic Threshold (VAT)
Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises:~End of programme follow-up:~Workstream 1; n = 13/30 Workstream 2; n = 29/40 Total = 42/70.~4-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 16/40 Total = 26/70.~12-week follow-up: Workstream 1; n = 9/30 Workstream 2; n = 20/40 Total = 29/70.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Intensity Interval Training | Ventilatory Anaerobic Threshold (VAT) | Workstream 2 - baseline VAT | 10.0 ml/kg/min | Standard Deviation 1.9 |
| High-Intensity Interval Training | Ventilatory Anaerobic Threshold (VAT) | Workstream 2 - post-intervention follow-up VAT | 10.4 ml/kg/min | Standard Deviation 2.2 |
| High-Intensity Interval Training | Ventilatory Anaerobic Threshold (VAT) | Workstream 2 - 4-week post-intervention follow-up VAT | 9.8 ml/kg/min | Standard Deviation 2.1 |
| High-Intensity Interval Training | Ventilatory Anaerobic Threshold (VAT) | Workstream 2 - 12-week post-intervention follow-up VAT | 10.1 ml/kg/min | Standard Deviation 2.2 |
| High-Intensity Interval Training | Ventilatory Anaerobic Threshold (VAT) | Workstream 1 - baseline VAT | 9.8 ml/kg/min | Standard Deviation 1.7 |
| High-Intensity Interval Training | Ventilatory Anaerobic Threshold (VAT) | Workstream 1 - post-intervention follow-up VAT | 10.2 ml/kg/min | Standard Deviation 1.7 |
| High-Intensity Interval Training | Ventilatory Anaerobic Threshold (VAT) | Workstream 1 - 4-week post-intervention follow-up VAT | 10.0 ml/kg/min | Standard Deviation 1.3 |
| High-Intensity Interval Training | Ventilatory Anaerobic Threshold (VAT) | Workstream 1 - 12-week post-intervention follow-up VAT | 9.4 ml/kg/min | Standard Deviation 1.4 |