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

Hasselt University

Status: Enrolling

Conditions: Stroke, Acute

Treatments: Other: Conventional physiotherapy; Other: HIIT-RCE

Study type: Interventional

Funder types: Other

Identifiers

NCT06179173

CLERB-UP023/2023

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

HIIT-RCE

Experimental group

Description:

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.

Treatment:

Other: HIIT-RCE

Conventional physiotherapy

Active Comparator group

Description:

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.

Treatment:

Other: Conventional physiotherapy