An interventional study of Recreational team handball programme in Peripheral Arterial Disease (PAD), sponsored by University Institute of Maia. Not yet recruiting at 1 site in Portugal. Open to male participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University Institute of Maia · Not applicable, Interventional, and Treatment
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.
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.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's planned enrollment of 60 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →University Institute of Maia is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Compared within Intermittent Claudication, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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.
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.
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
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 24 weeks
Peripheral Artery Questionnaire (PAQ) score
Disease-specific health status reported by the patients will be assessed using Peripheral artery questionnaire (PAQ).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Plan to share: No — 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.
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