Stroke, Acute
Conditions
Brief 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. We hypothesized that HIIT combined with conventional physiotherapy would be more effective than conventional physiotherapy in improving workload capacity.
Interventions
OTHERHIIT-RCE
High-intensity interval training on semi-recumbent cycle ergometer
OTHERConventional physiotherapy
Conventional physiotherapy
Sponsors
Université de Parakou
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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 1. first episode from an ischemic or hemorrhagic stroke confirmed by CT scan; 2. 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; 3. modified Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively 4. able to walk at least 5 meters independently with or without assistive devices and understand simple instructions; 5. resident in Parakou or its surroundings 6. wish to participate in the hospital program
Exclusion criteria
Patients whose medical records reported 1. uncontrolled cardiac arrhythmias (e.g. atrial fibrillation, ventricular tachycardia), heart failure, or recent myocardial infarction, arteriopathy, 2. primary orthopedic conditions (e.g., fractures, active rheumatoid arthritis), 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Workload capacity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The EQ-5D-5L | At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months(T3) after intervention | 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). |
| The Berg Balance Scale (BBS), | At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention | 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. |
| The 6-minute walk test (6MWT) | At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention | 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. |
| The 10-meter Walk Test (10mWT) | At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention | 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. |
| The 5-Repetition Sit-To-Stand test (5R-STS) | At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention | 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. |
Countries
Benin
Contacts
Primary ContactDominique Hansen, PhD
Backup ContactElogni R Amanzonwé, MSc, PhD student
Outcome results
None listed