Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07582588

Recreational Team Handball Programme for Patients With Peripheral Arterial Disease

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

60 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 6-min walk test total distance covered

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

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

Secondary outcomes

  1. Pain-free walking distance during the 6-min walk test

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

    Distance covered until onset of claudication (in meters) will be measured in patients during 6 minutes of continuous walking.

  2. Ankle-brachial-index at rest

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

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

  3. Upper limb muscle strength

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

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

  4. 5-repetition sit-to-stand test

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

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

  5. Systolic blood pressure

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

    At baseline, resting systolic blood pressure (mmHg) will be measured in both arms using an automated oscillometric sphygmomanometer, after 5 minutes of quiet rest, with 1 minute of recovery between readings. The arm with the higher systolic blood pressure will be identified and used for all subsequent assessments. Three consecutive measurements will be taken, with the mean of the three readings being recorded.

  6. Diastolic blood pressure

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

    At baseline, resting diastolic blood pressure (mmHg) will be measured in both arms using an automated oscillometric sphygmomanometer, after 5 minutes of quiet rest, with 1 minute of recovery between readings. The arm with the higher systolic blood pressure will be identified and used for all subsequent assessments. Three consecutive measurements will be taken, with the mean of the three readings being recorded.

  7. 4-metre gait speed test

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

    Gait speed (m/s) will be calculated by dividing the distance (4 metres) by the time taken to complete a straight-course walk at maximum speed.

  8. Total cholesterol

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

    Total cholesterol (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits.

  9. High-density lipoprotein cholesterol

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

    High-density lipoprotein cholesterol (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits.

  10. Low-density lipoprotein cholesterol

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

    Low-density lipoprotein cholesterol (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits.

  11. Triglycerides

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

    Triglycerides (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits.

  12. Glycosylated hemoglobin

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

    Glycosylated hemoglobin (%) will be analysed following standardised methods using commercial enzymatic test kits.

  13. Plasma interleukin-6

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

    Plasma interleukin-6 (pg/mL) will be analysed following standardised methods using commercial enzymatic test kits.

  14. Resting heart rate

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

    Number of heart beats per minute, measured by heart rate monitors.

  15. Maximum oxygen consumption

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

    Maximum oxygen consumption (mL/kg/min) will be determined by pulmonary gas exchange measurements during a maximal incremented exercise test in a cycle ergometer.

  16. Body mass index

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

    Determined by measuring stature (cm) and body mass(kg) and thereafter dividing the body mass by the square of the stature in metres (kg/m2) of each patient.

  17. Bone mineral density

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

    Bone mineral density (g / cm2 - grams of bone mineral content per area or analyzed bone cm2) will be measured by Dual Energy X-ray Absorptiometry.

  18. Bone mineral content

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

    Bone mineral content (grams) will be measured by Dual Energy X-ray Absorptiometry.

  19. Lean mass

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

    Lean mass (grams) will be measured by Dual Energy X-ray Absorptiometry.

  20. Body fat

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

    Body fat (%) will be measured by Dual Energy X-ray Absorptiometry.

  21. Body mass

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

    Body mass (kg) will be measured by Dual Energy X-ray Absorptiometry.

  22. 36-Item Short-Form Health Survey (SF-36) score

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

    Health-related quality of life will be measured using the 36-Item Short-Form Health Survey (SF-36).

  23. Mental health

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

    Mental health domain will be measured using the 9-item patient health questionnaire (PHQ-9).

  24. Daily physical activity

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

    Physical activity levels will be measured utilizing the international physical activity questionnaire short form.

  25. Walking Impairment Questionnaire (WIQ) score

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

    Patient-reported walking ability will be assessed using the Walking Impairment Questionnaire (WIQ), that comprises 3 subscales: walking distance, walking speed, and ability to climb stairs.

  26. Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) score

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

    Patient motivation to exercise will be assessed using the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3).

  27. Mean relative heart rate

    Time frame: 24 weeks

    Mean relative heart rate (%HRmax) will be measured for every participant in the treatment group during each training session of the exercise programme.

  28. Mean absolute heart rate

    Time frame: 24 weeks

    Mean absolute heart rate (bpm) will be measured for every participant in the treatment group during each training session of the exercise programme.

  29. Differential ratings of perceived exertion

    Time frame: 24 weeks

    Differential ratings of perceived exertion (0-10) will be measured for every participant in the treatment group during each training session of the exercise programme. Higher scores indicate greater perceived exertion.

  30. Fun scores

    Time frame: 24 weeks

    Fun scores (0-10) using a visual analog scale will be measured for every participant in the treatment group during each training session of the exercise programme. Higher scores indicate greater enjoyment.

  31. Blood lactate

    Time frame: 24 weeks

    Blood lactate values (mmol/L) measurements during 4 training sessions will be performed for every participant in the treatment group of the exercise programme

  32. Number of accelerations per training session

    Time frame: 24 weeks

    The number of accelerations performed during each training session by every participant in the treatment group of the exercise programme will be measured.

  33. Number of decelerations per training session

    Time frame: 24 weeks

    Decelerations (m/s²) performed during each training session by every participant in the treatment group of the exercise programme will be measured

  34. Post-exercise ankle-brachial index

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

    Ankle-brachial index (ABI) will be measured for each participant immediately following the graded treadmill test performed according to the Gardner-Skinner protocol, using the same standardised procedures as the resting ABI assessment.

  35. Muscle oxygen saturation

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

    Skeletal muscle oxygen saturation (StO₂) will be assessed non-invasively using near-infrared spectroscopy (NIRS) positioned over the medial head of the gastrocnemius muscle of the most symptomatic lower limb. StO₂ will be analysed at rest and continuously throughout the graded treadmill test.

  36. Functional mobility

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

    Time (in seconds) required to rise from a chair, walk 3 metres, turn, and return to a seated position will be assessed using the timed up and go test.

  37. Fasting blood glucose

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

    Fasting blood glucose (mmol/L) will be measured from venous blood samples collected and analysed using automated analysers following standardised methods.

  38. Total distance covered per training session

    Time frame: 24 weeks

    Total distance covered (meters) during each training session by every participant in the treatment group of the exercise programme will be measured.

  39. Claudication pain per training session

    Time frame: 24 weeks

    Claudication pain experienced during each session will be assessed using the Intermittent Claudication Pain Scale (0-4). Participants will rate their perceived claudication pain at the end of each of the three periods.

  40. Number of falls per training session

    Time frame: 24 weeks

    Falls that occur during each training session by any participant in the treatment group of the exercise programme will be reported

  41. Peripheral Artery Questionnaire (PAQ) score

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

    Disease-specific health status reported by the patients will be assessed using Peripheral artery questionnaire (PAQ).

  42. Plasma insulin

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

    Plasma insulin (µIU/mL) will be measured from venous blood samples collected and analysed using automated analysers following standardised methods.

  43. Peak relative heart rate

    Time frame: 24 weeks

    Peak relative heart rate (%HRmax) will be measured for every participant in the treatment group during each training session of the exercise programme.

  44. Peak absolute heart rate

    Time frame: 24 weeks

    Peak absolute heart rate (bpm) will be measured for every participant in the treatment group during each training session of the exercise programme.

  45. 30-seconds sit-to-stand test

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

    Maximal number of repetitions performed of sitting and standing on a chair during 30 seconds will be assessed.

  46. Smoking status

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

    Smoking status will be classified into three categories: current smoker, former smoker, and never smoker. Participants will self-report their smoking history at each assessment timepoint.

  47. Daily cigarette consumption

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

    Current smokers will self-report the average number of cigarettes smoked per day over the previous week at each assessment timepoint.

  48. Pain-free walking distance during a treadmill test

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

    Distance (in metres) at which the patient first reports onset of claudication pain during the graded treadmill test performed according to the Gardner-Skinner protocol will be recorded.

  49. Total walking distance covered during a treadmill test

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

    Total distance covered (in metres) at which the patient reaches maximal tolerable claudication pain and is unable to continue walking during the graded treadmill test performed according to the Gardner-Skinner protocol will be recorded.

  50. Four Square Step Test

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

    Dynamic balance will be assessed using the Four Square Step Test (FSST). Participants will step forward, sideways, and backward over two canes placed in a cross pattern on the floor, completing a full sequence in both clockwise and counterclockwise directions as fast as possible. The time (in seconds) to complete the test will be recorded.

  51. Single Leg Stance Test

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

    Static balance will be assessed using the Single Leg Stance Test (SLST). Participants will be instructed to stand on one leg with hands placed on the hips and eyes open during 60 seconds. Timing begins when the raised foot leaves the ground and stops when the foot touches the ground or the hands leave the hips. The time (in seconds) achieved on the preferentiallower limb will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Susana A Póvoas, PhD

CONTACT

[email protected]

+351918777814

Sponsors and collaborators

Lead sponsor

University Institute of Maia

Other

Registry information

Official study title

RUSH (Rehabilitation Using Sequential Handball): Promoting Health in Patients With Peripheral Arterial Disease With Intermittent Claudication Through a Progressive Recreational Team Handball-based Programme

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.