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

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.