Stroke, AcuteNCT05804006
High-Intensity Interval Training in the Early Subacute Stroke With a Semi-recumbent Bike
A study testing Conventional physiotherapy followed by HIIT-REC program in people with Stroke, Acute, run by Hasselt University at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Conventional physiotherapy followed by HIIT-REC program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Faculty of Rehabilitation Sciences
Diepenbeek, 3590
Elogni R Amanzonwé, PhD, +22995607820, renaud.amanzonwe@uhasselt.be
Peter Feys, PhD, peter.feys@uhasselt.be
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Acute
- Being tested
- Conventional physiotherapy followed by HIIT-REC program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapy followed by HIIT-REC programOther
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
| Study group | Role | What they receive |
|---|---|---|
| HIIT-REC | Experimental | High-intensity interval training program on a recumbent cycle SOLE R92 (HIIT-REC) Receives: Other: Conventional physiotherapy followed by HIIT-REC program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Week 1 and Week 6
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: Week 1 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Dec 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Conventional physiotherapy followed by High-Intensity Interval training on the semi-recumbent bike
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Parakou
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Oyene R Kossi, PhD, Study director, University of ParakouThierry R Adoukonou, MD, PhD, Study director, University of ParakouPeter R Feys, PhD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804006
- Sponsor's protocol ID
- 0557CLERB-UP/P/SP/R/SA
- Status last verified
- Apr 2023
- First submitted
- 15 Feb 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available to researchers upon request to the first author (ERA)
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05804006
- Acronym / sponsor ID
- 0557CLERB-UP/P/SP/R/SA
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Université de Parakou
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Conventional physiotherapy followed by High-Intensity Interval training on the semi-recumbent bike
| Arm | Type | Receives |
|---|---|---|
| HIIT-REC | Experimental | Other: Conventional physiotherapy followed by HIIT-REC programHigh-intensity interval training program on a recumbent cycle SOLE R92 (HIIT-REC) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physiotherapy followed by HIIT-REC programThe 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 | Other | HIIT-REC |
Primary outcome
Feasibility aspects
Time frame: Up to 6 weeks
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
Time frame: Week 1 and Week 6
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
7 secondary outcomes
Berg Balance Scale
Time frame: Week 1 and Week 6
5-Repetition Sit-To-Stand test
Time frame: Week 1 and Week 6
modified Rankin Scale
Time frame: Week 1 and Week 6
6-min walk test
Time frame: Week 1 and Week 6
10 m walk test
Time frame: Week 1 and Week 6
Mini-Mental Stage Examination
Time frame: Week 1 and Week 6
The 5-level EQ-5D version
Time frame: Week 1 and Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No. Data will be available to researchers upon request to the first author (ERA)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oyene R Kossi, PhD study director
University of Parakou
Thierry R Adoukonou, MD, PhD study director
University of Parakou
Peter R Feys, PhD principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physiotherapy followed by HIIT-REC program in people with Stroke, Acute, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elogni R Amanzonwé, MSc (+22995607820, renaud.amanzonwe@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility aspects (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.