About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Recreational team handball programme
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
6-min walk test total distance covered
Total distance covered (in meters) by each patient during 6 minutes of continuous walking will be assessed.
Secondary outcomes
Pain-free walking distance during the 6-min walk test
Distance covered until onset of claudication (in meters) will be measured in patients during 6 minutes of continuous walking.
Ankle-brachial-index at rest
Ankle-brachial index will be measured for each participant at rest.
Upper limb muscle strength
The peak force (in kg) will be measured in patients using the hand-held dynamometry test.
5-repetition sit-to-stand test
Time taken (seconds) to perform the 5 repetitions of sitting and standing on a chair will be assessed.
Sponsors and contacts
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