Chronic StrokeNCT06474832
High Intensity Interval Training in Chronic Stroke
A study testing High-intensity interval training and Moderate intensity continuous training in people with Chronic Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Both gait and cardiovascular dysfunction are primary factors limiting community ambulation for stroke individuals. Increased gait variability and asymmetry contributes to a higher risk of falls, leading to reduced physical activity, decreased cardiorespiratory endurance, and increased walking economy and sympathetic… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- High-intensity interval training and Moderate intensity continuous training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jul 2024to 31 Dec 2025
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-69 years
- At least 6 months post-stroke
- Functional Ambulation Category (FAC) ≥ 3
- Mini-Mental State Examination (MMSE) ≥ 24
- Able to walk 10 meters overground with or without assistive devices
Who cannot join
- Unstable cardiopulmonary conditions within the last 3 months
- Other chronic neurological disorders
- Contraindications to exercise as recommended by the American College of Sports Medicine (ACSM)
- Severe lower limb spasticity (Modified Ashworth Scale > 2 points)
- Implanted pacemaker or cardioverter defibrillator
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Taipei, 112
Yea-Ru Yang, PhD, +886-2-2826-7279, yryang@nycu.edu.tw
About this study
Official title: Effects of High Intensity Interval Training on Cardiorespiratory Fitness and Gait Quality in People With Chronic Stroke
Both gait and cardiovascular dysfunction are primary factors limiting community ambulation for stroke individuals. Increased gait variability and asymmetry contributes to a higher risk of falls, leading to reduced physical activity, decreased cardiorespiratory endurance, and increased walking economy and sympathetic nervous system activity, thereby potentially triggering secondary strokes. Previous studies have primarily focused on the significant improvements in walking endurance and speed with high-intensity interval training (HIIT) on a treadmill, leaving a gap in understanding the effects of HIIT on oxygen uptake efficiency slope (OUES) and gait quality for stroke individuals using a stationary bicycle ergometer with exergaming. Therefore, this study aims to investigate the effects of HIIT using a stationary bicycle ergometer on improving cardiorespiratory fitness and gait quality in individuals with chronic stroke.
- Conditions
- Chronic Stroke
- Being tested
- High-intensity interval training, Moderate intensity continuous training
- Keywords
- High-intensity interval training, Cardiorespiratory fitness, Gait quality, Chronic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
Training on a stationary bike and integrated with exergame (Jbike, JACFIT, USA), the exercise games connect to a map in the app through sensors, allowing players from different countries to ride together and complete the map, thus increasing the diversity of the training, including a warm-up and cool-down at 30% HRR for 5 minutes each. Perform HIIT with 5 intervals at 80% heart rate reserve (HRR), each interval lasting 4 minutes, with 3-minute intervals at 40% HRR between each interval.
Moderate intensity continuous trainingOther
Training on a stationary bike and integrated with exergame (Jbike, JACFIT, USA), the exercise games connect to a map in the app through sensors, allowing players from different countries to ride together and complete the map, thus increasing the diversity of the training, including a warm-up and cool-down at 30% HRR for 5 minutes each. Perform continuous exercise at 59% HRR for 35 minutes.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training group | Experimental | The intervention is a 42-minute session and 3-sessions/week, totaling 8 weeks. Receives: Other: High-intensity interval training |
| Moderate intensity continuous training group | Active comparator | The intervention is a 45-minute session and 3-sessions/week, totaling 8 weeks. Receives: Other: Moderate intensity continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen uptake efficiency slope (OUES): cardiovascular fitness
Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort.
OUES = Oxygen uptake / Log10 * Minute ventilation
Measured: Change from baseline at 8 weeks
Gait variability
Using GAITRite system to measure coefficient of variation. During the assessment, participants will be asked to walk three times. The mean and standard deviation will be used to calculate the coefficient of variation (CV).
CV = standard deviation / mean * 100%
Measured: Change from baseline at 8 weeks
Gait symmetry index (SI)
Use the GAITRite system to assess the symmetry of spatial and temporal gait parameters. During the assessment, participants will be asked to walk three times. Calculate the symmetry index using the mean.
SI = (affected side - unaffected side) / (1/2 * (affected side + unaffected side)) * 100%
Measured: Change from baseline at 8 weeks
Secondary outcomes (6)
Peak oxygen consumption (VO2peak): cardiovascular fitness
Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort.
Measured: Change from baseline at 8 weeks
Minute ventilation (VE) / carbon dioxide production (VCO2) slope: cardiovascular fitness
Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort.
VE/VCO2 slope = minute ventilation / carbon dioxide production
Measured: Change from baseline at 8 weeks
Heart rate recovery (HRR): cardiovascular fitness-
Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort.
HRR = peak heart rate - heart rate after one minute
Measured: Change from baseline at 8 weeks
Blood pressure (BP): cardiovascular fitness
Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort.
Measured: Change from baseline at 8 weeks
6 minutes walking distance (6MWD): cardiovascular fitness
For the 6MWD, participants are asked to walk as fast as possible along a 30-meter corridor. During the test, heart rate and blood oxygen saturation level are continuously monitored. Record heart rate, blood pressure, blood oxygen saturation level, RPE, and total walking distance before and after the test.
Measured: Change from baseline at 8 weeks
International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form)
The IPAQ is a self-reported instrument assesses the time spent in the past 7 days on activities including work, housework, gardening/balcony work, commuting, leisure, and exercise. Total time spent per week is multiplied by the metabolic equivalent (MET) and summed to present the total MET-minutes per week. Physical activity intensity is classified into walking (3.3 METs), moderate (4.0 METs), and vigorous (8.0 METs).
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start16 Jul 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474832
- Sponsor's protocol ID
- NYCU113060AF
- Status last verified
- Sep 2024
- First submitted
- 19 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Interval Training on Cardiorespiratory Fitness and Gait Quality in People With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06474832
- Acronym / sponsor ID
- NYCU113060AF
- Conditions
- Chronic Stroke
- Keywords
- High-intensity interval training, Cardiorespiratory fitness, Gait quality, Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jun 2024 (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.
Both gait and cardiovascular dysfunction are primary factors limiting community ambulation for stroke individuals. Increased gait variability and asymmetry contributes to a higher risk of falls, leading to reduced physical activity, decreased cardiorespiratory endurance, and increased walking economy and sympathetic nervous system activity, thereby potentially triggering secondary strokes. Previous studies have primarily focused on the significant improvements in walking endurance and speed with high-intensity interval training (HIIT) on a treadmill, leaving a gap in understanding the effects of HIIT on oxygen uptake efficiency slope (OUES) and gait quality for stroke individuals using a stationary bicycle ergometer with exergaming. Therefore, this study aims to investigate the effects of HIIT using a stationary bicycle ergometer on improving cardiorespiratory fitness and gait quality in individuals with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training group | Experimental | Other: High-intensity interval trainingThe intervention is a 42-minute session and 3-sessions/week, totaling 8 weeks. |
| Moderate intensity continuous training group | Active comparator | Other: Moderate intensity continuous trainingThe intervention is a 45-minute session and 3-sessions/week, totaling 8 weeks. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-69 years
- At least 6 months post-stroke
- Functional Ambulation Category (FAC) ≥ 3
- Mini-Mental State Examination (MMSE) ≥ 24
- Able to walk 10 meters overground with or without assistive devices
Key exclusion criteria (5 listed)
- Unstable cardiopulmonary conditions within the last 3 months
- Other chronic neurological disorders
- Contraindications to exercise as recommended by the American College of Sports Medicine (ACSM)
- Severe lower limb spasticity (Modified Ashworth Scale > 2 points)
- Implanted pacemaker or cardioverter defibrillator
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 |
|---|---|---|
| High-intensity interval trainingTraining on a stationary bike and integrated with exergame (Jbike, JACFIT, USA), the exercise games connect to a map in the app through sensors, allowing players from different countries to ride together and complete the map, thus increasing the diversity of the training, including a warm-up and cool-down at 30% HRR for 5 minutes each. Perform HIIT with 5 intervals at 80% heart rate reserve (HRR), each interval lasting 4 minutes, with 3-minute intervals at 40% HRR between each interval. | Other | High-intensity interval training group |
| Moderate intensity continuous trainingTraining on a stationary bike and integrated with exergame (Jbike, JACFIT, USA), the exercise games connect to a map in the app through sensors, allowing players from different countries to ride together and complete the map, thus increasing the diversity of the training, including a warm-up and cool-down at 30% HRR for 5 minutes each. Perform continuous exercise at 59% HRR for 35 minutes. | Other | Moderate intensity continuous training group |
Primary outcome
Oxygen uptake efficiency slope (OUES): cardiovascular fitness
Time frame: Change from baseline at 8 weeks
Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort. OUES = Oxygen uptake / Log10 * Minute ventilation
Gait variability
Time frame: Change from baseline at 8 weeks
Using GAITRite system to measure coefficient of variation. During the assessment, participants will be asked to walk three times. The mean and standard deviation will be used to calculate the coefficient of variation (CV). CV = standard deviation / mean * 100%
Gait symmetry index (SI)
Time frame: Change from baseline at 8 weeks
Use the GAITRite system to assess the symmetry of spatial and temporal gait parameters. During the assessment, participants will be asked to walk three times. Calculate the symmetry index using the mean. SI = (affected side - unaffected side) / (1/2 * (affected side + unaffected side)) * 100%
6 secondary outcomes
Peak oxygen consumption (VO2peak): cardiovascular fitness
Time frame: Change from baseline at 8 weeks
Minute ventilation (VE) / carbon dioxide production (VCO2) slope: cardiovascular fitness
Time frame: Change from baseline at 8 weeks
Heart rate recovery (HRR): cardiovascular fitness-
Time frame: Change from baseline at 8 weeks
Blood pressure (BP): cardiovascular fitness
Time frame: Change from baseline at 8 weeks
6 minutes walking distance (6MWD): cardiovascular fitness
Time frame: Change from baseline at 8 weeks
International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form)
Time frame: Change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Moderate intensity continuous training in people with Chronic Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 19 Sep 2024. 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 Taiwan. 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 Yea-Ru Yang, PhD (+886-2-2826-7279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen uptake efficiency slope (OUES): cardiovascular fitness (time frame: Change from baseline at 8 weeks). The study lists 3 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 19 Sep 2024.