Effectiveness of High-intensity Aerobic Interval Training on Impairments and Activity Limitations in the Acute Phase of Stroke in Benin

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stroke, Acute

Intervention / Treatment
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* Other: HIIT-RCE
* Other: Conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIIT-RCE<br>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. | Other: HIIT-RCE<br>* High-intensity interval training on semi-recumbent cycle ergometer<br>|
| Active Comparator: Conventional physiotherapy<br>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. | Other: Conventional physiotherapy<br>* Conventional physiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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). | At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months(T3) after intervention |