Intermittent Claudication, Peripheral Artery Disease
Conditions
Keywords
home-based exercise, circuit training, walking
Brief summary
The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication.
Detailed description
30 participants with PAD will be randomised to one of two groups: either exercise or usual care. The 12 week exercise intervention will consist of a home-based circuit programme, including both resistance exercises and walking. This will be combined with promoting free-living walking throughout the rest of the week. Exercise will be regulated via the use of a wearable activity monitor. Biweekly phone calls will address compliance with the intervention. The primary outcomes are feasibility and acceptability, which will be determined after 12 weeks via recruitment and attrition rates, protocol adherence and with participant interviews. Secondary outcomes include changes in pain-free and maximal walking distances with both a graded treadmill test and six-minute walk test, hand grip strength, physical activity behaviour (measured with an accelerometer), quality of life (measured with the SF-36, VascuQol and E5-5D-5L questionnaires) after 12 and 24 weeks. Investigators will also assess changes in markers of inflammation, vascular remodeling, mitochondrial biogenesis and oxidative stress at 12 and 24 weeks. Other outcomes include changes in time spent resting during a six-minute walk test and time to pain cessation following a graded treadmill test at 12 and 24 weeks.
Interventions
BEHAVIORALExercise group
The exercise group will receive a 12-week home-based exercise programme, with a wearable activity watch to regulate physical activity behaviour. This group will also receive biweekly telephone calls from the investigator.
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
Coventry University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ankle/brachial index (ABPI) \< 0.9 at rest or a drop of 20mmHg after exercise testing * Ability to walk independently * English speaking * Able to follow instructions * ≥ 18 years of age
Exclusion criteria
* Unable to provide informed consent * Walking impairment for a reason that is not PAD * Critical limb ischaemia * Asymptomatic PAD * Active cancer treatment * Severe mental or physical limitations precluding participation safely in the home environment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention feasibility assessed via recruitment rate | Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion) | The investigators will record the number of eligible participants, as well as the number who enroll onto the study. |
| Intervention feasibility assessed via attrition rate | Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion) | The investigators will record the number of protocol discontinuations and losses to follow-up. |
| Intervention feasibility assessed via protocol adherence | Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion) | The investigators will examine discrepancies between intervention prescription and what is completed. |
| Intervention acceptability via participant interviews | Will be evaluated after the intervention period (either at 12 week or 24 week follow up) | One-to-one interviews will be held between an investigator and participant who has either completed the intervention, withdrawn or declined participation, to ask questions regarding the intervention protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12 and 24 week change in circulating markers of vascular remodelling | Baseline to 12 weeks and 24 weeks | Investigators will compare blood sample measures of VEGF between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks. |
| 12 and 24 week change in VascuQol questionnaire score | Baseline to 12 weeks and 24 weeks | Change in Vascular Quality of Life questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 1-7, with higher scores associated with a better outcome). |
| 12 and 24 week change in EQ-5D-5L questionnaire score | Baseline to 12 weeks and 24 weeks | Change in European Quality of Life Five Dimension questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Scores range from 1-5, with lower scores associated with a better outcome). |
| 12 and 24 week change in circulating markers of inflammation | Baseline to 12 weeks and 24 weeks | Investigators will compare blood sample measures of IL-6, TNF-α, CRP between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks. |
| 12 and 24 week change in six-minute walk distance and pain-free walk distance | Baseline to 12 weeks and 24 weeks | Change in six-minute and pain-free walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
| 12 and 24 week change in pain-free and maximal treadmill walk distance | Baseline to 12 weeks and 24 weeks | Change in pain-free and maximal treadmill walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
| 12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer) | Baseline to 12 weeks and 24 weeks | Change in left and right hand grip strength after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
| 12 and 24 week change in physical activity measured by accelerometer data | Baseline to 12 weeks and 24 weeks | Change in physical activity behaviour at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group, using accelerometer data. |
| 12 and 24 week change in SF-36 score | Baseline to 12 weeks and 24 weeks | Change in 36 Item Short Form survey scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 0-100, with higher scores associated with a better outcome). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 12 and 24 week change in pain cessation following a treadmill test | Baseline to 12 weeks and 24 weeks | Change in time to pain cessation following a treadmill test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
| 12 and 24 week changes in walking speed during a six-minute walk test | Baseline to 12 weeks and 24 weeks | Change in walking speed during a six-minute walk test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
| 12 and 24 week change in rest times during a six-minute walk test | Baseline to 12 weeks and 24 weeks | Change in time spent resting during a six-minute walk test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
Countries
United Kingdom
Outcome results
None listed