Recreational Team Handball Programme for Patients With Peripheral Arterial Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age60-80
SponsorUniversity Institute of Maia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Recreational team handball programme

    Other intervention

    Participants 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

60 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Usual care/control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

6-min walk test total distance covered

Total distance covered (in meters) by each patient during 6 minutes of continuous walking will be assessed.

Time frame
Baseline, 12 weeks and 24 weeks after the beginning of the intervention

Secondary outcomes

1

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.

Time frame
Baseline, 12 and 24 weeks after the beginning of the intervention
2

Ankle-brachial-index at rest

Ankle-brachial index will be measured for each participant at rest.

Time frame
Baseline, 12 weeks and 24 weeks after the beginning of the intervention
3

Upper limb muscle strength

The peak force (in kg) will be measured in patients using the hand-held dynamometry test.

Time frame
Baseline, 12 and 24 weeks after the beginning of the intervention
4

5-repetition sit-to-stand test

Time taken (seconds) to perform the 5 repetitions of sitting and standing on a chair will be assessed.

Time frame
Baseline, 12 weeks and 24 weeks after the beginning of the intervention

Other outcomes

Sponsors and contacts

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