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

Not Applicable

Recruiting

• Conditions: Stroke, Acute

• Registration Number: NCT06179173
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-10-03
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21
• Primary Completion: 2024-01-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

University Hospital of Parakou; 🇧🇯 Parakou, Benin