Peripheral Arterial Disease (PAD)NCT07582588
Recreational Team Handball Programme for Patients With Peripheral Arterial Disease
A study testing Recreational team handball programme in people with Peripheral Arterial Disease (PAD), run by University Institute of Maia at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 years, men only
- Conditions the study is for
- Peripheral Arterial Disease (PAD)
- What is being tested?
- Recreational team handball programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 14 May 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
University of Maia
Maia
Susana A Póvoas, PhD, +351918777814, spovoas@umaia.pt
About this study
Official 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
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease (PAD)
- Being tested
- Recreational team handball programme
- Keywords
- Exercise rehabilitation, Peripheral arterial disease, Intermittent claudication, Walking sports
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recreational team handball programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-min walk test total distance covered
Total distance covered (in meters) by each patient during 6 minutes of continuous walking will be assessed.
Measured: 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
Distance covered until onset of claudication (in meters) will be measured in patients during 6 minutes of continuous walking.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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
Measured: 24 weeks
Peripheral Artery Questionnaire (PAQ) score
Disease-specific health status reported by the patients will be assessed using Peripheral artery questionnaire (PAQ).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start14 May 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease (PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Institute of Maia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susana Cristina Araújo Póvoas, University Institute of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582588
- Sponsor's protocol ID
- 10/2026
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07582588
- Acronym / sponsor ID
- 10/2026
- Conditions
- Peripheral Arterial Disease (PAD)
- Keywords
- Exercise rehabilitation, Peripheral arterial disease, Intermittent claudication, Walking sports
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Institute of MaiaUniversity, hospital or other
- Study start
- 14 May 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Recreational team handball programmeParticipants 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. |
| 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recreational team handball programmeParticipants 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 | Intervention group |
Primary outcome
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.
51 secondary outcomes
Pain-free walking distance during the 6-min walk test
Time frame: Baseline, 12 and 24 weeks after the beginning of the intervention
Ankle-brachial-index at rest
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Upper limb muscle strength
Time frame: Baseline, 12 and 24 weeks after the beginning of the intervention
5-repetition sit-to-stand test
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Systolic blood pressure
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Diastolic blood pressure
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
4-metre gait speed test
Time frame: Baseline, 12 and 24 weeks after the beginning of the intervention
Total cholesterol
Time frame: Baseline, 12 and 24 weeks after the beginning of the intervention
High-density lipoprotein cholesterol
Time frame: Baseline, 12 and 24 weeks after the beginning of the intervention
Low-density lipoprotein cholesterol
Time frame: Baseline, 12 and 24 weeks after the beginning of the intervention
Triglycerides
Time frame: Baseline, 12 and 24 weeks after the beginning of the intervention
Glycosylated hemoglobin
Time frame: Baseline, 12 and 24 weeks after the beginning of the intervention
Plasma interleukin-6
Time frame: Baseline, 12 and 24 weeks after the beginning of the intervention
Resting heart rate
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Maximum oxygen consumption
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Body mass index
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Bone mineral density
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Bone mineral content
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Lean mass
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Body fat
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Body mass
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
36-Item Short-Form Health Survey (SF-36) score
Time frame: Baseline, 12 week and 24 weeks after the beginning of the intervention
Mental health
Time frame: Baseline, 12 week and 24 weeks after the beginning of the intervention
Daily physical activity
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Walking Impairment Questionnaire (WIQ) score
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) score
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Mean relative heart rate
Time frame: 24 weeks
Mean absolute heart rate
Time frame: 24 weeks
Differential ratings of perceived exertion
Time frame: 24 weeks
Fun scores
Time frame: 24 weeks
Blood lactate
Time frame: 24 weeks
Number of accelerations per training session
Time frame: 24 weeks
Number of decelerations per training session
Time frame: 24 weeks
Post-exercise ankle-brachial index
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Muscle oxygen saturation
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Functional mobility
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Fasting blood glucose
Time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention
Total distance covered per training session
Time frame: 24 weeks
Claudication pain per training session
Time frame: 24 weeks
Number of falls per training session
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: 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.
Related trials for Peripheral Arterial Disease (PAD)
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recreational team handball programme in people with Peripheral Arterial Disease (PAD), run by University Institute of Maia at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susana A Póvoas, PhD (+351918777814, spovoas@umaia.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-min walk test total distance covered (time frame: Baseline, 12 weeks and 24 weeks after the beginning of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.