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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06179173
Other study ID # CLERB-UP023/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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