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

Stroke, Acute Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179173
• Other study ID #: CLERB-UP023/2023
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: Hasselt University
• Contact: Dominique Hansen, PhD
• Phone: +32497875866
• Email: dominique.hansen[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. We hypothesized that HIIT combined with conventional physiotherapy would be more effective than conventional physiotherapy in improving workload capacity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Other:
• HIIT-RCE
High-intensity interval training on semi-recumbent cycle ergometer
• Conventional physiotherapy
Conventional physiotherapy

Locations

Country	Name	City	State
Benin	University Hospital of Parakou	Parakou

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Université de Parakou

Country where clinical trial is conducted

Benin, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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