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

NCT ID: NCT06179173

Last Updated: 2023-12-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-04-30

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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HIIT-RCE

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.

Group Type: EXPERIMENTAL

HIIT-RCE

Intervention Type: OTHER

High-intensity interval training on semi-recumbent cycle ergometer

Conventional physiotherapy

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.

Group Type: ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type: OTHER

Conventional physiotherapy

Interventions

HIIT-RCE

High-intensity interval training on semi-recumbent cycle ergometer

Intervention Type: OTHER

Conventional physiotherapy

Conventional physiotherapy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Parakou

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Dominique Hansen

Full Professor of Rehabilitation and Exercise Physiology in Cardiometabolic Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominique R Hansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

University Hospital of Parakou

Parakou, , Benin

Site Status: RECRUITING

Countries

Benin

Central Contacts

Dominique Hansen, PhD

Role: CONTACT

Phone: +32497875866

Email: dominique.hansen@uhasselt.be

Elogni R Amanzonwé, MSc, PhD student

Role: CONTACT

Phone: +22995607820

Email: renaud.amanzonwe@uhasselt.be

Facility Contacts

Oyene R Kossi, PhD

Role: primary

References

Amanzonwe ER, Noukpo SI, Adoukonou T, Bonnechere B, Feys P, Hansen D, Kossi O. Exercise Intensity Matters in the Rehabilitation of Stroke in the Acute Stage: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Aug 11:15459683251356969. doi: 10.1177/15459683251356969. Online ahead of print.

Reference Type: DERIVED

PMID: 40788139 (View on PubMed)

Other Identifiers

CLERB-UP023/2023

Identifier Type: -

Identifier Source: org_study_id