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

NCT06179173 | Unknown DMC

• 1 other identifier: CLERB-UP023/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Berg Balance Scale (BBS),

  At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention

• 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 10-meter Walk Test (10mWT)

  At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention

• 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 EQ-5D-5L

  At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months(T3) after intervention

Study Arms (2)

HIIT-RCE

EXPERIMENTAL

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.

Other: HIIT-RCE

Conventional physiotherapy

ACTIVE COMPARATOR

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.

Other: Conventional physiotherapy

Interventions

HIIT-RCE OTHER

High-intensity interval training on semi-recumbent cycle ergometer

HIIT-RCE

Conventional physiotherapy OTHER

Conventional physiotherapy

Conventional physiotherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with the diagnosis of stroke were screened and recruited within the first-month after the stroke onset according to the following criteria
• first episode from an ischemic or hemorrhagic stroke confirmed by CT scan;
• 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;
• modified Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively
• able to walk at least 5 meters independently with or without assistive devices and understand simple instructions;
• resident in Parakou or its surroundings
• wish to participate in the hospital program

You may not qualify if:

• Patients whose medical records reported
• uncontrolled cardiac arrhythmias (e.g. atrial fibrillation, ventricular tachycardia), heart failure, or recent myocardial infarction, arteriopathy,
• primary orthopedic conditions (e.g., fractures, active rheumatoid arthritis),
• 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

Sponsors & Collaborators

• Hasselt University: lead
• Université de Parakou: collaborator

Study Sites (1)

University Hospital of Parakou

Parakou, Benin

RECRUITING

Related Publications (1)

• 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 Nov;39(11):892-905. doi: 10.1177/15459683251356969. Epub 2025 Aug 11.

  PMID: 40788139 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dominique R Hansen, PhD

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Hansen, PhD

CONTACT

+32497875866; dominique.hansen@uhasselt.be

Elogni R Amanzonwé, MSc, PhD student

CONTACT

+22995607820; renaud.amanzonwe@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Rehabilitation and Exercise Physiology in Cardiometabolic Diseases

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: December 21, 2023
• Study Start: January 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: April 30, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)