Stroke, AcuteNCT06179173
Effectiveness of High-intensity Aerobic Interval Training on Impairments and Activity Limitations in the Acute Phase of Stroke in Benin
A study testing HIIT-RCE and Conventional physiotherapy in people with Stroke, Acute, run by Hasselt University at 1 site in Benin.
Trial summary
This clinical trial aims to examine the effects of combining HIIT on a semi-recumbent cycle ergometer (HIIT-RCE) with conventional physiotherapy on impairments and activity limitations in early subacute stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- HIIT-RCE and Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBenin
- Study dates
- 1 Jan 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with the diagnosis of stroke were screened and recruited within the first-month after the stroke onset according to the following criteria
- first episode from an ischemic or hemorrhagic stroke confirmed by CT scan;
- muscle strength of the affected leg defined by Motricity Index between 14 and 19, i.e., between 2 and 4 on the Medical Research Council scale;
- modified Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively
- able to walk at least 5 meters independently with or without assistive devices and understand simple instructions;
- resident in Parakou or its surroundings
- wish to participate in the hospital program
Who cannot join
- Patients whose medical records reported
- uncontrolled cardiac arrhythmias (e.g. atrial fibrillation, ventricular tachycardia), heart failure, or recent myocardial infarction, arteriopathy,
- primary orthopedic conditions (e.g., fractures, active rheumatoid arthritis),
- other neurological diseases (such as Parkinson's disease and Alzheimer's disease), (4) patients unable to perform a graded exercise test, i.e., unable to reach the target cadence of 50 rpm or exercise-induced asthma
Trial locations and contacts
1 site in 1 country.
Benin1 site, 1 recruiting
- Recruiting
University Hospital of Parakou
Parakou
Oyene R Kossi, PhD, +229 97 16 02 60, oyene.kossi@gmail.com
Elogni R Amanzonwé, MSc.
About this study
Official title: Is High-intensity Aerobic Interval Training Appropriate for Recovering Impairments and Activity Limitations in the Acute Phase of Stroke? A Randomized Controlled Trial in Benin
This clinical trial aims to examine the effects of combining HIIT on a semi-recumbent cycle ergometer (HIIT-RCE) with conventional physiotherapy on impairments and activity limitations in early subacute stroke. We hypothesized that HIIT combined with conventional physiotherapy would be more effective than conventional physiotherapy in improving workload capacity.
- Conditions
- Stroke, Acute
- Being tested
- HIIT-RCE, Conventional physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT-RCEOther
High-intensity interval training on semi-recumbent cycle ergometer
Conventional physiotherapyOther
Conventional physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| HIIT-RCE | Experimental | All participants will receive conventional physiotherapy for half an hour thrice weekly for six weeks. Conventional physiotherapy will be followed by a 15 min rest period, then the HIIT on a semi-recumbent cycle SOLE R92 (HIIT-RCE) will be performed.Each HIIT-RCE session will be preceded by 3-min of unloaded cycling as a warm-up and ended with 3-min of stretching. The HIIT-RCE procedure will start at 4-min at 30% of the peak workload interspersed with 1-min at 70% of the peak workload for weeks 1-2 (4 repetitions for 20 min) and increased by approximately 5 minutes every two weeks as tolerated to reach 30 minutes from week 5 (6 repetitions). The training intensity will progress similarly by 5% peak work rate two weeks as tolerated to reach 4-min at 40% peak workload interspersed with 1-min 80% peak workload from week-5. The cycle frequency will be at least 50 rpm. Receives: Other: HIIT-RCE |
| Conventional physiotherapy | Active comparator | The group will receive conventional physiotherapy that will consist primarily of passive movement, stretching, balance training, strengthening, and lower intensity overground walking for 30 minutes. This will be followed by a 15-minute rest period. Then an unloaded cycling session on a semi-recumbent cycle ergometer with preferred cadence until to get equal energy expenditure per session between groups by case-matching. Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Workload capacity
A progressive intensity maximal effort cycling test will be performed in a semi-recumbent ergometer cycle (SOLE R90) to determine each participant's peak workload (in watts).
Measured: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
Secondary outcomes (5)
The Berg Balance Scale (BBS),
The BBS will be used to assess balance impairment. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. The minimum score is 0 and the maximum score is 56. A score of 56 indicates functional balance and a score < 45 indicates a higher risk of falling.
Measured: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
The 6-minute walk test (6MWT)
The 6MWT is a measure of walking endurance. 35,36 It assesses the distance a participant can walk as fast as possible for 6 min on a 30 m straight line with the option to stop for fatigue at any point.
Measured: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
The 10-meter Walk Test (10mWT)
The 10mWT is a performance measure used to assess walking speed in meters per second over the middle 10 meters of a 14-meter course.
Measured: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
The 5-Repetition Sit-To-Stand test (5R-STS)
The 5R-STS test measures the time to complete five repetitions of the sit-to-stand maneuver. Participants unable to complete five repetitions within 1-min will be given a score of 60 s.
Measured: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
The EQ-5D-5L
The EQ-5D-5L is a self-assessed, health-related, quality of life questionnaire validated for acute stroke. It has 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of 5 items each, and scores range from 0 (best quality of life) to 1 (worst quality of life).
Measured: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months(T3) after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Parakou
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique R Hansen, PhD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179173
- Sponsor's protocol ID
- CLERB-UP023/2023
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available to researchers upon request to the first author (ERA)
Publications
Amanzonwe ER, Noukpo SI, Adoukonou T, Bonnechere B, Feys P, Hansen D, Kossi O. Exercise Intensity Matters in the Rehabilitation of Stroke in the Acute Stage: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Nov;39(11):892-905. doi: 10.1177/15459683251356969. Epub 2025 Aug 11.
PubMed 40788139
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is High-intensity Aerobic Interval Training Appropriate for Recovering Impairments and Activity Limitations in the Acute Phase of Stroke? A Randomized Controlled Trial in Benin
- ClinicalTrials.gov ID
- NCT06179173
- Acronym / sponsor ID
- CLERB-UP023/2023
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Université de Parakou
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 21 Dec 2023 (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 clinical trial aims to examine the effects of combining HIIT on a semi-recumbent cycle ergometer (HIIT-RCE) with conventional physiotherapy on impairments and activity limitations in early subacute stroke. We hypothesized that HIIT combined with conventional physiotherapy would be more effective than conventional physiotherapy in improving workload capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT-RCE | Experimental | Other: HIIT-RCEAll participants will receive conventional physiotherapy for half an hour thrice weekly for six weeks. Conventional physiotherapy will be followed by a 15 min rest period, then the HIIT on a semi-recumbent cycle SOLE R92 (HIIT-RCE) will be performed.Each HIIT-RCE session will be preceded by 3-min of unloaded cycling as a warm-up and ended with 3-min of stretching. The HIIT-RCE procedure will start at 4-min at 30% of the peak workload interspersed with 1-min at 70% of the peak workload for weeks 1-2 (4 repetitions for 20 min) and increased by approximately 5 minutes every two weeks as tolerated to reach 30 minutes from week 5 (6 repetitions). The training intensity will progress similarly by 5% peak work rate two weeks as tolerated to reach 4-min at 40% peak workload interspersed with 1-min 80% peak workload from week-5. The cycle frequency will be at least 50 rpm. |
| Conventional physiotherapy | Active comparator | Other: Conventional physiotherapyThe group will receive conventional physiotherapy that will consist primarily of passive movement, stretching, balance training, strengthening, and lower intensity overground walking for 30 minutes. This will be followed by a 15-minute rest period. Then an unloaded cycling session on a semi-recumbent cycle ergometer with preferred cadence until to get equal energy expenditure per session between groups by case-matching. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- People with the diagnosis of stroke were screened and recruited within the first-month after the stroke onset according to the following criteria
- first episode from an ischemic or hemorrhagic stroke confirmed by CT scan;
- muscle strength of the affected leg defined by Motricity Index between 14 and 19, i.e., between 2 and 4 on the Medical Research Council scale;
- modified Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively
- able to walk at least 5 meters independently with or without assistive devices and understand simple instructions;
Key exclusion criteria (4 listed)
- Patients whose medical records reported
- uncontrolled cardiac arrhythmias (e.g. atrial fibrillation, ventricular tachycardia), heart failure, or recent myocardial infarction, arteriopathy,
- primary orthopedic conditions (e.g., fractures, active rheumatoid arthritis),
- other neurological diseases (such as Parkinson's disease and Alzheimer's disease), (4) patients unable to perform a graded exercise test, i.e., unable to reach the target cadence of 50 rpm or exercise-induced asthma
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 |
|---|---|---|
| HIIT-RCEHigh-intensity interval training on semi-recumbent cycle ergometer | Other | HIIT-RCE |
| Conventional physiotherapyConventional physiotherapy | Other | Conventional physiotherapy |
Primary outcome
Workload capacity
Time frame: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
A progressive intensity maximal effort cycling test will be performed in a semi-recumbent ergometer cycle (SOLE R90) to determine each participant's peak workload (in watts).
5 secondary outcomes
The Berg Balance Scale (BBS),
Time frame: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
The 6-minute walk test (6MWT)
Time frame: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
The 10-meter Walk Test (10mWT)
Time frame: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
The 5-Repetition Sit-To-Stand test (5R-STS)
Time frame: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention
The EQ-5D-5L
Time frame: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months(T3) after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Derived from this study: PubMed 40788139Amanzonwe ER, Noukpo SI, Adoukonou T, Bonnechere B, Feys P, Hansen D, Kossi O. Exercise Intensity Matters in the Rehabilitation of Stroke in the Acute Stage: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Nov;39(11):892-905. doi: 10.1177/15459683251356969. Epub 2025 Aug 11.
- Individual participant dataSharing planned: No. Data will be available to researchers upon request to the first author (ERA)
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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. This study is not recruiting at the moment.
Dominique R Hansen, PhD principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT-RCE and Conventional physiotherapy in people with Stroke, Acute, run by Hasselt University at 1 site in Benin.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Dec 2023. 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 Benin. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Hansen, PhD (+32497875866, dominique.hansen@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Workload capacity (time frame: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06179173, which also lists 1 linked publication.
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 21 Dec 2023.