Recreational Team Handball Programme for Patients With Peripheral Arterial Disease (NCT07582588) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Recreational Team Handball Programme for Patients With Peripheral Arterial Disease
Portugal60 participantsStarted 2026-05-14
Plain-language 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.
Who can participate
Age range
60 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6-min walk test total distance covered
Timeframe: Baseline, 12 weeks and 24 weeks after the beginning of the intervention