Recreational Team Handball Programme for Patients With Peripheral Arterial Disease

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.

• Pain-free walking distance during the 6-min walk test [Срок оценки: Baseline, 12 and 24 weeks after the beginning of the intervention]
• Ankle-brachial-index at rest [Срок оценки: Baseline, 12 weeks and 24 weeks after the beginning of the intervention]
• Upper limb muscle strength [Срок оценки: Baseline, 12 and 24 weeks after the beginning of the intervention]
• 5-repetition sit-to-stand test [Срок оценки: Baseline, 12 weeks and 24 weeks after the beginning of the intervention]
• Systolic blood pressure [Срок оценки: Baseline, 12 weeks and 24 weeks after the beginning of the intervention]
• Diastolic blood pressure [Срок оценки: Baseline, 12 weeks and 24 weeks after the beginning of the intervention]
• 4-metre gait speed test [Срок оценки: Baseline, 12 and 24 weeks after the beginning of the intervention]
• Total cholesterol [Срок оценки: Baseline, 12 and 24 weeks after the beginning of the intervention]
• High-density lipoprotein cholesterol [Срок оценки: Baseline, 12 and 24 weeks after the beginning of the intervention]
• Low-density lipoprotein cholesterol [Срок оценки: Baseline, 12 and 24 weeks after the beginning of the intervention]
• Triglycerides [Срок оценки: Baseline, 12 and 24 weeks after the beginning of the intervention]
• Glycosylated hemoglobin [Срок оценки: Baseline, 12 and 24 weeks after the beginning of the intervention]