Recreational Team Handball Programme for Patients With Peripheral Arterial Disease

RUSH (Rehabilitation Using Sequential Handball): Promoting Health in Patients With Peripheral Arterial Disease With Intermittent Claudication Through a Progressive Recreational Team Handball-based Programme

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.

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.

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