Recreational Team Handball Programme for Patients With Peripheral Arterial Disease

NCT07582588 | Not Yet Recruiting

• 1 other identifier: 10/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease (PAD)

Keywords

Exercise rehabilitation; Peripheral arterial disease; Intermittent claudication; Walking sports

Outcome Measures

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.

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

Secondary Outcomes (51)

• Pain-free walking distance during the 6-min walk test

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

• Ankle-brachial-index at rest

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

• Upper limb muscle strength

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

• 5-repetition sit-to-stand test

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

• Systolic blood pressure

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Recreational team handball programme

Usual care/control group

NO INTERVENTION

Participants allocated to the control group will continue receiving usual medical care in accordance with standard clinical practice. Furthermore, participants will be advised to maintain their current lifestyle and physical activity habits for the duration of the study. No supervised exercise programme will be provided by the research team during the 24-week intervention period. Following the final 24-week assessments, control group participants will be offered the opportunity to participate in the progressive recreational handball programme.

Interventions

Recreational team handball programme OTHER

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.

Intervention group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Institute of Maia: lead

Study Sites (1)

University of Maia

Maia, Portugal

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Susana A Póvoas, PhD

CONTACT

+351918777814; spovoas@umaia.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 13, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)