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

Primary Purpose

Stroke, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Conventional physiotherapy followed by HIIT-REC program
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: first episode from an ischemic or hemorrhagic stroke confirmed by CT scan; muscular weakness of the leg on the hemiplegic side defined as NIHSS-Item 6 score between 1 and 3; 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 spoken instructions; living in Parakou or the surrounding area and wishing to undergo the program at the hospital. Exclusion Criteria: Participants: unable to perform a graded exercise test, i.e., unable to maintain the designated pedaling rate; cardiovascular diseases (uncontrolled arrhythmias, decompensated heart failure or recent myocardial injury, arteriopathy); primary orthopedic conditions (fractures, active rheumatoid arthritis); other neurological diseases such as (Parkinson's disease and Alzheimer's disease).

Sites / Locations

  • Faculty of Rehabilitation SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIIT-REC

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

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.
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.
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)
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.
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
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)
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

Full Information

First Posted
February 15, 2023
Last Updated
April 6, 2023
Sponsor
Hasselt University
Collaborators
Université de Parakou
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1. Study Identification

Unique Protocol Identification Number
NCT05804006
Brief Title
High-Intensity Interval Training in the Early Subacute Stroke With a Semi-recumbent Bike
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Université de Parakou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Conventional physiotherapy followed by High-Intensity Interval training on the semi-recumbent bike
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIIT-REC
Arm Type
Experimental
Arm Description
High-intensity interval training program on a recumbent cycle SOLE R92 (HIIT-REC)
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy followed by HIIT-REC program
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility aspects
Description
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)
Time Frame
Up to 6 weeks
Title
The change in the credibility of the treatment and the expectations of the participants
Description
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
Time Frame
Week 1 and Week 6
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
Week 1 and Week 6
Title
5-Repetition Sit-To-Stand test
Description
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.
Time Frame
Week 1 and Week 6
Title
modified Rankin Scale
Description
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)
Time Frame
Week 1 and Week 6
Title
6-min walk test
Description
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.
Time Frame
Week 1 and Week 6
Title
10 m walk test
Description
The 10mWT will be used to evaluate walking speed. It assesses the walking speed in meters per second over a short distance
Time Frame
Week 1 and Week 6
Title
Mini-Mental Stage Examination
Description
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)
Time Frame
Week 1 and Week 6
Title
The 5-level EQ-5D version
Description
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
Time Frame
Week 1 and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first episode from an ischemic or hemorrhagic stroke confirmed by CT scan; muscular weakness of the leg on the hemiplegic side defined as NIHSS-Item 6 score between 1 and 3; 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 spoken instructions; living in Parakou or the surrounding area and wishing to undergo the program at the hospital. Exclusion Criteria: Participants: unable to perform a graded exercise test, i.e., unable to maintain the designated pedaling rate; cardiovascular diseases (uncontrolled arrhythmias, decompensated heart failure or recent myocardial injury, arteriopathy); primary orthopedic conditions (fractures, active rheumatoid arthritis); other neurological diseases such as (Parkinson's disease and Alzheimer's disease).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elogni R Amanzonwé, MSc
Phone
+22995607820
Email
renaud.amanzonwe@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Hansen, PhD
Phone
+32 497 87 58 66
Email
dominique.hansen@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oyene R Kossi, PhD
Organizational Affiliation
University of Parakou
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thierry R Adoukonou, MD, PhD
Organizational Affiliation
University of Parakou
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter R Feys, PhD
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Rehabilitation Sciences
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elogni R Amanzonwé, PhD
Phone
+22995607820
Email
renaud.amanzonwe@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Peter Feys, PhD
Email
peter.feys@uhasselt.be

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available to researchers upon request to the first author (ERA)

Learn more about this trial

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

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