Peripheral Arterial Disease (PAD)
Conditions
Keywords
Exercise rehabilitation, Peripheral arterial disease, Intermittent claudication, Walking sports
Brief summary
This randomized controlled trial (RCT) aims to evaluate the physical and physiological demands, the feasibility and the health, physical fitness and disease-specific outcomes of a progressive recreational team handball-based programme in patients with lower extremity peripheral arterial disease and intermittent claudication. The primary outcomes will be changes in functional capacity, assessed by the 6-minute walk test. Participants will be randomized to either a 24-week progressive team handball-based intervention or a usual care control group, with assessments performed at baseline, 12 weeks, and 24 weeks post intervention to evaluate health, physical fitness, and disease- specific outcomes.
Detailed description
Randomization: After all baseline assessments, participants will be randomized 1:1 to the intervention or control group. Randomization will be performed by a researcher not involved in data collection or outcome assessment. Blinding of participants and instructors, coaches and the investigation team leading the training sessions is not feasible in this type of exercise intervention. Outcome evaluators, who are not involved in intervention delivery or group allocation, will remain blinded to group assignment throughout all assessment time points (baseline, 12 weeks, and 24 weeks). Statistical analysis: All statistical analysis will be performed using the most recent version of R. The required sample size was determined by a prior calculation based on the between-group difference in change in 6-min walk distance at 24 weeks. Assuming a clinically relevant difference of 40 m, SD of change ≈ 60 m, α = 0.05 and 80% power (two-sample t test on change scores), 48 patients (24 per group) are required. Allowing for 20-25% attrition, the target sample is 60 patients (30 per group). Data will be screened for normality and outliers prior to the analysis. The primary analysis will then be conducted using linear mixed models (LMM), without the use of ad hoc imputations. The LMM will include group (intervention, control), time (baseline, post-12 weeks, post-24 weeks), and the group × time interaction as fixed effects, with participant included as a random intercept to account for individual variability. The primary statistical approach will follow the intention-to-treat (ITT) principle. In addition, a per-protocol (34) sensitivity analysis will be performed, including patients who attended at least 60% of the prescribed exercise sessions and completed the 24-week follow-up assessments. Significant main effects or interactions will be explored using Bonferroni corrected post-hoc comparisons. Statistical significance will be set at p \< 0.05.
Interventions
Participants allocated to the intervention group will undertake a 24-week progressive recreational handball programme performed three times per week, with each session lasting 40-60 minutes, under the supervision of qualified sports education graduates and members of the research team. The intervention is divided into two sequential phases to ensure safe progression. During the first 12 weeks, participants will partake in walking handball training sessions, followed by 12 weeks of recreational team handball.
Sponsors
University Institute of Maia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 60-80-year-old males * Diagnosed with stage II LEPAD secondary to arteriosclerosis * Ankle-brachial index \< 0.90 in one or both lower limbs * With or without former revascularization surgery * With medical clearance from the physician to perform moderate-to-vigorous intensity exercise
Exclusion criteria
* Diagnosed with stage I, III or IV LEPAD * Advanced retinopathy or kidney failure * Incapability to grab a ball * Other cardiovascular disease (heart failure, atrial fibrillation, valvular heart disease, unstable angina or other uncontrolled arrhythmias, obstructive coronary disease, acquired or advance heart block) * Diabetic neuropathy * Foot ulcers * Uncontrolled hypertension * History of major depression or other severe psychiatric disorders * Cancer * Severe hepatic impairment * Previous amputation surgery * Adherence to regular physical activity or exercise (\>2 hours and half per week) in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-min walk test total distance covered | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Total distance covered (in meters) by each patient during 6 minutes of continuous walking will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle oxygen saturation | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Skeletal muscle oxygen saturation (StO₂) will be assessed non-invasively using near-infrared spectroscopy (NIRS) positioned over the medial head of the gastrocnemius muscle of the most symptomatic lower limb. StO₂ will be analysed at rest and continuously throughout the graded treadmill test. |
| Functional mobility | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Time (in seconds) required to rise from a chair, walk 3 metres, turn, and return to a seated position will be assessed using the timed up and go test. |
| Fasting blood glucose | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Fasting blood glucose (mmol/L) will be measured from venous blood samples collected and analysed using automated analysers following standardised methods. |
| Total distance covered per training session | 24 weeks | Total distance covered (meters) during each training session by every participant in the treatment group of the exercise programme will be measured. |
| Claudication pain per training session | 24 weeks | Claudication pain experienced during each session will be assessed using the Intermittent Claudication Pain Scale (0-4). Participants will rate their perceived claudication pain at the end of each of the three periods. |
| Number of falls per training session | 24 weeks | Falls that occur during each training session by any participant in the treatment group of the exercise programme will be reported |
| Peripheral Artery Questionnaire (PAQ) score | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Disease-specific health status reported by the patients will be assessed using Peripheral artery questionnaire (PAQ). |
| Plasma insulin | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Plasma insulin (µIU/mL) will be measured from venous blood samples collected and analysed using automated analysers following standardised methods. |
| Peak relative heart rate | 24 weeks | Peak relative heart rate (%HRmax) will be measured for every participant in the treatment group during each training session of the exercise programme. |
| Peak absolute heart rate | 24 weeks | Peak absolute heart rate (bpm) will be measured for every participant in the treatment group during each training session of the exercise programme. |
| 30-seconds sit-to-stand test | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Maximal number of repetitions performed of sitting and standing on a chair during 30 seconds will be assessed. |
| Smoking status | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Smoking status will be classified into three categories: current smoker, former smoker, and never smoker. Participants will self-report their smoking history at each assessment timepoint. |
| Daily cigarette consumption | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Current smokers will self-report the average number of cigarettes smoked per day over the previous week at each assessment timepoint. |
| Pain-free walking distance during a treadmill test | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Distance (in metres) at which the patient first reports onset of claudication pain during the graded treadmill test performed according to the Gardner-Skinner protocol will be recorded. |
| Total walking distance covered during a treadmill test | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Total distance covered (in metres) at which the patient reaches maximal tolerable claudication pain and is unable to continue walking during the graded treadmill test performed according to the Gardner-Skinner protocol will be recorded. |
| Four Square Step Test | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Dynamic balance will be assessed using the Four Square Step Test (FSST). Participants will step forward, sideways, and backward over two canes placed in a cross pattern on the floor, completing a full sequence in both clockwise and counterclockwise directions as fast as possible. The time (in seconds) to complete the test will be recorded. |
| Single Leg Stance Test | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Static balance will be assessed using the Single Leg Stance Test (SLST). Participants will be instructed to stand on one leg with hands placed on the hips and eyes open during 60 seconds. Timing begins when the raised foot leaves the ground and stops when the foot touches the ground or the hands leave the hips. The time (in seconds) achieved on the preferentiallower limb will be reported. |
| Bone mineral content | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Bone mineral content (grams) will be measured by Dual Energy X-ray Absorptiometry. |
| Lean mass | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Lean mass (grams) will be measured by Dual Energy X-ray Absorptiometry. |
| Body fat | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Body fat (%) will be measured by Dual Energy X-ray Absorptiometry. |
| Body mass | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Body mass (kg) will be measured by Dual Energy X-ray Absorptiometry. |
| 36-Item Short-Form Health Survey (SF-36) score | Baseline, 12 week and 24 weeks after the beginning of the intervention | Health-related quality of life will be measured using the 36-Item Short-Form Health Survey (SF-36). |
| Mental health | Baseline, 12 week and 24 weeks after the beginning of the intervention | Mental health domain will be measured using the 9-item patient health questionnaire (PHQ-9). |
| Daily physical activity | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Physical activity levels will be measured utilizing the international physical activity questionnaire short form. |
| Walking Impairment Questionnaire (WIQ) score | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Patient-reported walking ability will be assessed using the Walking Impairment Questionnaire (WIQ), that comprises 3 subscales: walking distance, walking speed, and ability to climb stairs. |
| Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) score | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Patient motivation to exercise will be assessed using the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3). |
| Mean relative heart rate | 24 weeks | Mean relative heart rate (%HRmax) will be measured for every participant in the treatment group during each training session of the exercise programme. |
| Mean absolute heart rate | 24 weeks | Mean absolute heart rate (bpm) will be measured for every participant in the treatment group during each training session of the exercise programme. |
| Differential ratings of perceived exertion | 24 weeks | Differential ratings of perceived exertion (0-10) will be measured for every participant in the treatment group during each training session of the exercise programme. Higher scores indicate greater perceived exertion. |
| Fun scores | 24 weeks | Fun scores (0-10) using a visual analog scale will be measured for every participant in the treatment group during each training session of the exercise programme. Higher scores indicate greater enjoyment. |
| Blood lactate | 24 weeks | Blood lactate values (mmol/L) measurements during 4 training sessions will be performed for every participant in the treatment group of the exercise programme |
| Number of accelerations per training session | 24 weeks | The number of accelerations performed during each training session by every participant in the treatment group of the exercise programme will be measured. |
| Number of decelerations per training session | 24 weeks | Decelerations (m/s²) performed during each training session by every participant in the treatment group of the exercise programme will be measured |
| Bone mineral density | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Bone mineral density (g / cm2 - grams of bone mineral content per area or analyzed bone cm2) will be measured by Dual Energy X-ray Absorptiometry. |
| Pain-free walking distance during the 6-min walk test | Baseline, 12 and 24 weeks after the beginning of the intervention | Distance covered until onset of claudication (in meters) will be measured in patients during 6 minutes of continuous walking. |
| Ankle-brachial-index at rest | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Ankle-brachial index will be measured for each participant at rest. |
| Upper limb muscle strength | Baseline, 12 and 24 weeks after the beginning of the intervention | The peak force (in kg) will be measured in patients using the hand-held dynamometry test. |
| 5-repetition sit-to-stand test | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Time taken (seconds) to perform the 5 repetitions of sitting and standing on a chair will be assessed. |
| Systolic blood pressure | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | At baseline, resting systolic blood pressure (mmHg) will be measured in both arms using an automated oscillometric sphygmomanometer, after 5 minutes of quiet rest, with 1 minute of recovery between readings. The arm with the higher systolic blood pressure will be identified and used for all subsequent assessments. Three consecutive measurements will be taken, with the mean of the three readings being recorded. |
| Diastolic blood pressure | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | At baseline, resting diastolic blood pressure (mmHg) will be measured in both arms using an automated oscillometric sphygmomanometer, after 5 minutes of quiet rest, with 1 minute of recovery between readings. The arm with the higher systolic blood pressure will be identified and used for all subsequent assessments. Three consecutive measurements will be taken, with the mean of the three readings being recorded. |
| 4-metre gait speed test | Baseline, 12 and 24 weeks after the beginning of the intervention | Gait speed (m/s) will be calculated by dividing the distance (4 metres) by the time taken to complete a straight-course walk at maximum speed. |
| Total cholesterol | Baseline, 12 and 24 weeks after the beginning of the intervention | Total cholesterol (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits. |
| High-density lipoprotein cholesterol | Baseline, 12 and 24 weeks after the beginning of the intervention | High-density lipoprotein cholesterol (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits. |
| Low-density lipoprotein cholesterol | Baseline, 12 and 24 weeks after the beginning of the intervention | Low-density lipoprotein cholesterol (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits. |
| Triglycerides | Baseline, 12 and 24 weeks after the beginning of the intervention | Triglycerides (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits. |
| Glycosylated hemoglobin | Baseline, 12 and 24 weeks after the beginning of the intervention | Glycosylated hemoglobin (%) will be analysed following standardised methods using commercial enzymatic test kits. |
| Plasma interleukin-6 | Baseline, 12 and 24 weeks after the beginning of the intervention | Plasma interleukin-6 (pg/mL) will be analysed following standardised methods using commercial enzymatic test kits. |
| Resting heart rate | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Number of heart beats per minute, measured by heart rate monitors. |
| Maximum oxygen consumption | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Maximum oxygen consumption (mL/kg/min) will be determined by pulmonary gas exchange measurements during a maximal incremented exercise test in a cycle ergometer. |
| Post-exercise ankle-brachial index | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Ankle-brachial index (ABI) will be measured for each participant immediately following the graded treadmill test performed according to the Gardner-Skinner protocol, using the same standardised procedures as the resting ABI assessment. |
| Body mass index | Baseline, 12 weeks and 24 weeks after the beginning of the intervention | Determined by measuring stature (cm) and body mass(kg) and thereafter dividing the body mass by the square of the stature in metres (kg/m2) of each patient. |
Countries
Portugal
Contacts
CONTACTSusana A Póvoas, PhD
Outcome results
None listed