University of Maia
Maia, Portugal
NCT Number: NCT07582588
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.
Trial opening soon.
Get Notified60 year–80 year
Male
Interventional
Not applicable
Maia, Portugal
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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).
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.
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.
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.
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.
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
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.
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
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.
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.
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.
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.
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.
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.
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
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University Institute of Maia
Other
RUSH (Rehabilitation Using Sequential Handball): Promoting Health in Patients With Peripheral Arterial Disease With Intermittent Claudication Through a Progressive Recreational Team Handball-based Programme
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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.
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