Recreational Team Handball Programme for Patients With Peripheral Arterial Disease

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease (PAD)
• Intervention / Treatment: Other: Recreational team handball programme

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susana A Póvoas, PhD; Phone Number: +351918777814; Email: spovoas@umaia.pt

Study Locations

• Portugal
  • Maia, Portugal
    • University of Maia
    • Contact: Susana A Póvoas, PhD; Phone Number: +351918777814; Email: spovoas@umaia.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.
No Intervention: Usual care/control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 12 and 24 weeks after the beginning of the intervention
Ankle-brachial-index at rest	Ankle-brachial index will be measured for each participant at rest.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Upper limb muscle strength	The peak force (in kg) will be measured in patients using the hand-held dynamometry test.	Baseline, 12 and 24 weeks after the beginning of the intervention
5-repetition sit-to-stand test	Time taken (seconds) to perform the 5 repetitions of sitting and standing on a chair will be assessed.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Systolic blood pressure	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Diastolic blood pressure	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
4-metre gait speed test	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.	Baseline, 12 and 24 weeks after the beginning of the intervention
Total cholesterol	Total cholesterol (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits.	Baseline, 12 and 24 weeks after the beginning of the intervention
High-density lipoprotein cholesterol	High-density lipoprotein cholesterol (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits.	Baseline, 12 and 24 weeks after the beginning of the intervention
Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits.	Baseline, 12 and 24 weeks after the beginning of the intervention
Triglycerides	Triglycerides (mmol/L) will be analysed following standardised methods using commercial enzymatic test kits.	Baseline, 12 and 24 weeks after the beginning of the intervention
Glycosylated hemoglobin	Glycosylated hemoglobin (%) will be analysed following standardised methods using commercial enzymatic test kits.	Baseline, 12 and 24 weeks after the beginning of the intervention
Plasma interleukin-6	Plasma interleukin-6 (pg/mL) will be analysed following standardised methods using commercial enzymatic test kits.	Baseline, 12 and 24 weeks after the beginning of the intervention
Resting heart rate	Number of heart beats per minute, measured by heart rate monitors.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Maximum oxygen consumption	Maximum oxygen consumption (mL/kg/min) will be determined by pulmonary gas exchange measurements during a maximal incremented exercise test in a cycle ergometer.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Body mass index	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Bone mineral density	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Bone mineral content	Bone mineral content (grams) will be measured by Dual Energy X-ray Absorptiometry.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Lean mass	Lean mass (grams) will be measured by Dual Energy X-ray Absorptiometry.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Body fat	Body fat (%) will be measured by Dual Energy X-ray Absorptiometry.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Body mass	Body mass (kg) will be measured by Dual Energy X-ray Absorptiometry.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
36-Item Short-Form Health Survey (SF-36) score	Health-related quality of life will be measured using the 36-Item Short-Form Health Survey (SF-36).	Baseline, 12 week and 24 weeks after the beginning of the intervention
Mental health	Mental health domain will be measured using the 9-item patient health questionnaire (PHQ-9).	Baseline, 12 week and 24 weeks after the beginning of the intervention
Daily physical activity	Physical activity levels will be measured utilizing the international physical activity questionnaire short form.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Walking Impairment Questionnaire (WIQ) score	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) score	Patient motivation to exercise will be assessed using the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3).	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Mean relative heart rate	Mean relative heart rate (%HRmax) will be measured for every participant in the treatment group during each training session of the exercise programme.	24 weeks
Mean absolute heart rate	Mean absolute heart rate (bpm) will be measured for every participant in the treatment group during each training session of the exercise programme.	24 weeks
Differential ratings of perceived exertion	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.	24 weeks
Fun scores	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.	24 weeks
Blood lactate	Blood lactate values (mmol/L) measurements during 4 training sessions will be performed for every participant in the treatment group of the exercise programme	24 weeks
Number of accelerations per training session	The number of accelerations performed during each training session by every participant in the treatment group of the exercise programme will be measured.	24 weeks
Number of decelerations per training session	Decelerations (m/s²) performed during each training session by every participant in the treatment group of the exercise programme will be measured	24 weeks
Post-exercise ankle-brachial index	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Muscle oxygen saturation	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Functional mobility	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Fasting blood glucose	Fasting blood glucose (mmol/L) will be measured from venous blood samples collected and analysed using automated analysers following standardised methods.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Total distance covered per training session	Total distance covered (meters) during each training session by every participant in the treatment group of the exercise programme will be measured.	24 weeks
Claudication pain per training session	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.	24 weeks
Number of falls per training session	Falls that occur during each training session by any participant in the treatment group of the exercise programme will be reported	24 weeks
Peripheral Artery Questionnaire (PAQ) score	Disease-specific health status reported by the patients will be assessed using Peripheral artery questionnaire (PAQ).	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Plasma insulin	Plasma insulin (µIU/mL) will be measured from venous blood samples collected and analysed using automated analysers following standardised methods.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Peak relative heart rate	Peak relative heart rate (%HRmax) will be measured for every participant in the treatment group during each training session of the exercise programme.	24 weeks
Peak absolute heart rate	Peak absolute heart rate (bpm) will be measured for every participant in the treatment group during each training session of the exercise programme.	24 weeks
30-seconds sit-to-stand test	Maximal number of repetitions performed of sitting and standing on a chair during 30 seconds will be assessed.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Smoking status	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Daily cigarette consumption	Current smokers will self-report the average number of cigarettes smoked per day over the previous week at each assessment timepoint.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Pain-free walking distance during a treadmill test	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Total walking distance covered during a treadmill test	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Four Square Step Test	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Single Leg Stance Test	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.	Baseline, 12 weeks and 24 weeks after the beginning of the intervention

Collaborators and Investigators

• Sponsor: University Institute of Maia

Study record dates

Study Major Dates

• Study Start (Estimated): May 14, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Exercise rehabilitation; Intermittent claudication; Walking sports
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: 10/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be publicly shared due to confidentiality reasons. Aggregate data supporting the findings of this study may be made available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No