High-Intensity Interval Training in the Early Subacute Stroke With a Semi-recumbent Bike

The Feasibility and Effects of Recumbent Cycling-based High-intensity Interval Training on Functional Performances, Cognitive Function, and Quality of Life in Early Subacute Stroke

Although High-intensity interval training (HIIT) exercise has emerged in recent years as a powerful time-efficient alternative to moderate-intensity continuous cardiovascular exercise training (MICT) to enhance neuroplasticity, motor, and cognitive functions, its feasibility remains to be determined early after stroke. Our study aims to investigate the feasibility of the HIIT program and its effects on functional abilities, cognitive function, and quality of life in early post-stroke.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Other: Conventional physiotherapy followed by HIIT-REC program

Detailed Description

Study design, setting, and ethical considerations:

This study will be a prospective pre-post study that will be conducted at the university hospital of Parakou in Benin. The study protocol will be submitted to the ethics committee of Hasselt University in Belgium and the local biomedical ethics committee of the University of Parakou, Republic of Benin.

Interventions:

The experimental protocol will be preceded by 30 minutes of conventional physiotherapy, including neuromuscular interventions (balance training, postural awareness), musculoskeletal interventions (passive range of motion, stretching, strengthening), and lower-intensity overground walking. The conventional physiotherapy will be followed by 15 min of the rest period, then the experimental protocol consisting of a HIIT program on a recumbent cycle SOLE R92 (HIIT-REC) will be performed three times per week for six successive weeks.21 Training will be performed on non-consecutive days, thereby permitting recovery between sessions. The HIIT procedure will start at 4-min at 30% of the peak workload interspersed with 1-min at 70% of the peak workload at 50 rpm for weeks 1-2 and increased by approximately 5 minutes every two weeks as tolerated to reach 30 minutes from week 5 (4 to 6 repetitions). The training intensity will progress similarly by 5% peak workload two weeks as tolerated to reach 4-min at 40% peak workload interspersed with 1-min 80% peak workload from week-5.22 All sessions will be supervised and performed individually with verbal encouragement.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elogni R Amanzonwé, MSc; Phone Number: +22995607820; Email: renaud.amanzonwe@uhasselt.be
• Study Contact Backup: Name: Dominique Hansen, PhD; Phone Number: +32 497 87 58 66; Email: dominique.hansen@uhasselt.be

Study Locations

• Belgium
  • Diepenbeek, Belgium, 3590
    • Recruiting
    • Faculty of Rehabilitation Sciences
    • Contact: Elogni R Amanzonwé, PhD; Phone Number: +22995607820; Email: renaud.amanzonwe@uhasselt.be
    • Contact: Peter Feys, PhD; Email: peter.feys@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. first episode from an ischemic or hemorrhagic stroke confirmed by CT scan;
2. muscular weakness of the leg on the hemiplegic side defined as NIHSS-Item 6 score between 1 and 3;
3. 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 spoken instructions;
5. living in Parakou or the surrounding area and wishing to undergo the program at the hospital.

Exclusion Criteria:

Participants:

1. unable to perform a graded exercise test, i.e., unable to maintain the designated pedaling rate;
2. cardiovascular diseases (uncontrolled arrhythmias, decompensated heart failure or recent myocardial injury, arteriopathy);
3. primary orthopedic conditions (fractures, active rheumatoid arthritis);
4. other neurological diseases such as (Parkinson's disease and Alzheimer's disease).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HIIT-REC; High-intensity interval training program on a recumbent cycle SOLE R92 (HIIT-REC)

Other: Conventional physiotherapy followed by HIIT-REC program; The experimental protocol will be preceded by 30 minutes of conventional physiotherapy followed by 15 min the rest period; then the HIIT-REC procedure will start at 4-min at 30% of the peak workload interspersed with 1-min at 70% of the peak workload at 50 rpm for weeks 1-2 and increased by approximately 5 minutes every two weeks as tolerated to reach 30 minutes from week 5 (4 to 6 repetitions). The training intensity will progress similarly by 5% peak workload two weeks as tolerated to reach 4-min at 40% peak workload interspersed with 1-min 80% peak workload from week-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility aspects	The feasibility aspects, include recruitment rates (eligible population / consented population x 100), program adherence (attended sessions / total number of sessions x 100), and the safety (percentage of participants who will experience adverse events)	Up to 6 weeks
The change in the credibility of the treatment and the expectations of the participants	The treatment credibility and participant expectancy for improvement will be assessed with the Credibility and Expectancy Questionnaire (CEQ). The CEQ includes six items assessing a cognitively based credibility factor and an affectively based expectancy factor	Week 1 and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	The Berg Balance Scale 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.	Week 1 and Week 6
5-Repetition Sit-To-Stand test	We will evaluate functional lower extremity strength with the 5-Repetition Sit-To-Stand test. The 5-Repetition Sit-To-Stand test measures the time taken to complete five repetitions of the sit-to-stand maneuver.	Week 1 and Week 6
modified Rankin Scale	The modified Rankin Scale (mRS) will be used to evaluate the degree of disability in the daily activities. The mRS is an ordered scale coded from 0 (no symptoms at all) through 5 (severe disability)	Week 1 and Week 6
6-min walk test	The 6-min walk test will be used to assess walking endurance. 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.	Week 1 and Week 6
10 m walk test	The 10mWT will be used to evaluate walking speed. It assesses the walking speed in meters per second over a short distance	Week 1 and Week 6
Mini-Mental Stage Examination	The cognitive functions will be evaluated with the MMSE. It comprises thirty items providing information about orientation, attention, learning, calculation, delayed recall, and construction. The MMSE scores are interpreted as followed: > 25 (normal cognitive status), 18-23 (Mild cognitive impairment), and 0-17 (Severe cognitive impairment)	Week 1 and Week 6
The 5-level EQ-5D version	We will use the EQ-5D-5L to assess the health-related quality of life (HRQoL). It comprises five health dimensions such as mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems	Week 1 and Week 6

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Université de Parakou
• Investigators: Study Director: Oyene R Kossi, PhD, University of Parakou; Study Director: Thierry R Adoukonou, MD, PhD, University of Parakou; Principal Investigator: Peter R Feys, PhD, Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 0557CLERB-UP/P/SP/R/SA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available to researchers upon request to the first author (ERA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No