StrokeNCT06554665
Powering Up Stroke Rehabilitation Through HIIT
A study testing High-intensity Interval Training, Moderate-Intensity Continuous Training and Stretching in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Objectives: To investigate the effects of high-intensity interval training (HIIT) on musculoskeletal fitness in chronic stroke survivors. Hypothesis to be tested: HIIT, performed on a recumbent stepper, will significantly enhance muscle power in chronic stroke survivors when compared with moderate-intensity continuous… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- High-intensity Interval Training, Moderate-Intensity Continuous Training and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Aug 2024to 5 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and postmenopausal women aged 50-80 years
- 1-5 years following the first-ever stroke confirmed by magnetic resonance imaging or computed tomography
- Able to walk 10 meters independently with or without a walking aid
- Class I or II according to the New York Heart Association Functional Classification (no limitation or slight limitation of physical activity due to symptoms during ordinary physical activity)
Who cannot join
- Presence of other neurological comorbidities, significant liver or renal diseases, thyroid or parathyroid diseases, rheumatoid arthritis, or a fracture within the past 6 months
- Undergoing osteoporosis treatments within the past 3 years, use of oral corticosteroids for more than 3 months within the past year, or botulinum toxin injections in the paretic lower limb within the past 6 months
- Participation in ongoing stroke rehabilitation services or structured exercise programme
- Cognitive or communication issues that could limit the ability to follow instructions
- Contraindications to HIIT, graded exercise testing, or failure to pass medical clearance from a specialist
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Kowloon
Chen Xu, PhD student, rschen.xu@connect.polyu.hk
Meizhen Huang, PhD, mei-zhen.huang@polyu.edu.hk
About this study
Official title: Powering Up Stroke Rehabilitation Through High-Intensity Interval Training
Objectives: To investigate the effects of high-intensity interval training (HIIT) on musculoskeletal fitness in chronic stroke survivors.
Hypothesis to be tested: HIIT, performed on a recumbent stepper, will significantly enhance muscle power in chronic stroke survivors when compared with moderate-intensity continuous training (MICT) Design and subjects: Assessor-blinded, stratified, randomised, placebo-controlled clinical trial involving eligible 66 chronic stroke survivors.
Read more
Interventions: Participants will be randomly allocated to one of three groups: the HIIT group, the MICT group, or a stretching group (active control). Each group will attend sessions three times per week for 12 consecutive weeks, totaling 36 training sessions.
Main outcome measures: Assessments will be conducted at baseline, at mid-term of the intervention (week 6), at the end of the intervention (week 12), and at a 12-week follow-up (week 24). The primary outcome measure will be muscle power. Secondary outcome measures will include muscle strength, body composition, biomarkers, motor function, balance function, cardiorespiratory response, and psychosocial response.
- Conditions
- Stroke
- Being tested
- High-intensity Interval Training, Moderate-Intensity Continuous Training, Stretching
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity Interval TrainingBehavioural
There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
Moderate-Intensity Continuous TrainingBehavioural
There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
StretchingBehavioural
There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | The HIIT session will consist of a 3-minute warm-up, a 20-minute main exercise, and a 2-minute cool-down. The main exercise for HIIT will include ten high-intensity intervals, interspersed with ten low-intensity intervals. Receives: Behavioral: High-intensity Interval Training |
| Moderate-intensity continuous training | Active comparator | The MICT session will consist of a 3-minute warm-up, a main exercise that approximately matches the total workload of the HIIT session (lasting about 30 minutes), and a 2-minute cool-down. The intensity during the main exercise for MICT will remain below the vigorous level by progressively adjusting the workload throughout the intervention period. Receives: Behavioral: Moderate-Intensity Continuous Training |
| Stretching | Active comparator | The stretching group will receive 25 minutes of whole-body stretching. Receives: Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Muscle Power at Week 12
Muscle power (watt) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer.
Change=(Week 12 Level - Baseline Level)
Measured: Baseline and Week 12
Secondary outcomes (21)
Change from Baseline in Muscle Power at Week 24
Muscle power (watt) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 24 Level - Baseline Level)
Measured: Baseline and Week 24
Change from Baseline in Muscle Strength (Nm) at Week 12
Muscle strength (Nm) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer.
Change=(Week 12 Level - Baseline Level)
Measured: Baseline and Week 12
Change from Baseline in Muscle Strength (Nm) at Week 24
Muscle strength (Nm) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer.
Change=(Week 24 Level - Baseline Level)
Measured: Baseline and Week 24
Change from Baseline in Muscle Strength (kg) at Week 12
Handgrip strength (kg) on both sides will be measured using a handheld dynamometer.
Change=(Week 12 Level - Baseline Level)
Measured: Baseline and Week 12
Change from Baseline in Muscle Strength (kg) at Week 24
Handgrip strength (kg) on both sides will be measured using a handheld dynamometer.
Change=(Week 24 Level - Baseline Level)
Measured: Baseline and Week 24
Change from Baseline in Body Composition (kg) at Week 12
Whole-body skeletal muscle mass (kg), bone mineral content (kg), fat mass (kg), and segmental lean mass (kg) will be measured using bioelectrical impedance analysis (BIA).
Change=(Week 12 Level - Baseline Level)
Measured: Baseline and Week 12
Change from Baseline in Body Composition (kg) at Week 24
Whole-body skeletal muscle mass (kg), bone mineral content (kg), fat mass (kg), and segmental lean mass (kg) will be measured using bioelectrical impedance analysis (BIA).
Change=(Week 24 Level - Baseline Level)
Measured: Baseline and Week 24
Change from Baseline in Body Composition (%) at Week 12
Body fat percentage (%) will be measured using bioelectrical impedance analysis (BIA).
Change=(Week 12 Level - Baseline Level)
Measured: Baseline and Week 12
Change from Baseline in Body Composition (%) at Week 24
Body fat percentage (%) will be measured using bioelectrical impedance analysis (BIA).
Change=(Week 24 Level - Baseline Level)
Measured: Baseline and Week 24
Change from Baseline in Biomarkers at Week 12
Volume-corrected serum concentration (mg/dL) of myokines, bone markers, pro-inflammatory markers, biomarkers of oxidative stress will be measured using enzyme-linked immunosorbent assay (ELISA) kits.
Change=(Week 12 Level - Baseline Level)
Measured: Baseline and Week 12
Change from Baseline in Biomarkers at Week 6
Volume-corrected serum concentration (mg/dL) of myokines, bone markers, pro-inflammatory markers, biomarkers of oxidative stress will be measured using enzyme-linked immunosorbent assay (ELISA) kits.
Change=(Week 6 Level - Baseline Level)
Measured: Baseline and Week 6
Change from Baseline in Motor Function at Week 12
Fugl-Meyer Motor Assessment (FMA) will be used to assess the degree of motor recovery of the hemiparetic upper (range: 0-66) and lower limbs (range: 0-34). Higher scores are indicative of better motor recovery. Short Physical Performance Battery (SPPB) will be used to assess the physical performance, including 5-times sit-to-stand, balance tests (side-by-side-stand, semi-tandem stand, and tandem stand), and gait speed.
Change=(Week 12 Score- Baseline Score)
Measured: Baseline and Week 12
Change from Baseline in Motor Function at Week 24
Fugl-Meyer Motor Assessment (FMA) will be used to assess the degree of motor recovery of the hemiparetic upper (range: 0-66) and lower limbs (range: 0-34). Higher scores are indicative of better motor recovery. Short Physical Performance Battery (SPPB) will be used to assess the physical performance, including 5-times sit-to-stand, balance tests (side-by-side-stand, semi-tandem stand, and tandem stand), and gait speed.
Change=(Week 24 Score- Baseline Score)
Measured: Baseline and Week 24
Change from Baseline in Motor Function (meters) at Week 12
The 6-minute walk test (6MWT) will be used to measure walking endurance and capacity. The total distance walked in meters during the test will be recorded.
Change=(Week 12 distance - Baseline distance)
Measured: Baseline and Week 12
Change from Baseline in Motor Function (meters) at Week 24
The 6-minute walk test (6MWT) will be used to measure walking endurance and capacity. The total distance walked in meters during the test will be recorded.
Change=(Week 24 distance - Baseline distance)
Measured: Baseline and Week 24
Change from Baseline in Balance Function at Week 12
Balance performance will be assessed using the Mini Balance Evaluation Systems Test (range: 0-28). Higher scores are indicative of better balance performance. Fear of falling will be assessed using the Chinese version of the Activities-Specific Balance Confidence Scale (range: 0-100). Higher scores are indicative of higher balance confidence.
Change=(Week 12 Score- Baseline Score)
Measured: Baseline and Week 12
Change from Baseline in Balance Function at Week 24
Balance performance will be assessed using the Mini Balance Evaluation Systems Test (range: 0-28). Higher scores are indicative of better balance performance. Fear of falling will be assessed using the Chinese version of the Activities-Specific Balance Confidence Scale (range: 0-100). Higher scores are indicative of higher balance confidence.
Change=(Week 24 Score- Baseline Score)
Measured: Baseline and Week 24
Change from Baseline in Cardiopulmonary Response at Week 12
Peak oxygen uptake (VO2peak) will be measured using a graded exercise test (GXT). The GXT will be conducted following a well-validated protocol that on a whole-body recumbent stepper to assess cardiopulmonary function in stroke patients.
Change=(Week 12 VO2peak - Baseline VO2peak)
Measured: Baseline and Week 12
Change from Baseline in Cardiopulmonary Response at Week 24
Peak oxygen uptake (VO2peak) will be measured using a graded exercise test (GXT). The GXT will be conducted following a well-validated protocol that on a whole-body recumbent stepper to assess cardiopulmonary function in stroke patients.
Change=(Week 24 VO2peak - Baseline VO2peak)
Measured: Baseline and Week 24
Change from Baseline in Psychosocial Responses at Week 12
Post-stroke fatigue will be assessed using the Fatigue Severity Scale (range: 1-7). Higher scores are indicative of more severe fatigue.
Health-related quality of life will be assessed using 12-Item Short Form Health Survey (range: 0-100). Higher scores are indicative of better quality of life.
Exercise enjoyment will be assessed by the Physical Activity Enjoyment Scale and Behavioural Regulation Exercise Questionnaire-3 (range: 0-400). Higher scores indicate a higher exercise enjoyment level.
Motivation for exercise will be assessed using the Behavioural Regulation Exercise Questionnaire-3 (range: 0-96). Higher scores indicate more motivation to exercise. A semi-structured interview will be additionally conducted at the end of the intervention (week 12) to explore the experiences of HIIT in stroke patients.
Change=(Week 12 Score - Baseline Score)
Measured: Baseline and Week 12
Change from Baseline in Psychosocial Responses at Week 24
Post-stroke fatigue will be assessed using the Fatigue Severity Scale (range: 1-7). Higher scores are indicative of more severe fatigue.
Health-related quality of life will be assessed using 12-Item Short Form Health Survey (range: 0-100). Higher scores are indicative of better quality of life.
Exercise enjoyment will be assessed by the Physical Activity Enjoyment Scale and Behavioural Regulation Exercise Questionnaire-3 (range: 0-400). Higher scores indicate a higher exercise enjoyment level.
Motivation for exercise will be assessed using the Behavioural Regulation Exercise Questionnaire-3 (range: 0-96). Higher scores indicate more motivation to exercise. A semi-structured interview will be additionally conducted at the end of the intervention (week 12) to explore the experiences of HIIT in stroke patients.
Change=(Week 24 Score - Baseline Score)
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start20 Aug 2024
- Primary completion5 Aug 2027 (estimated)
- Study completion5 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554665
- Sponsor's protocol ID
- HSEARS20230720002
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Powering Up Stroke Rehabilitation Through High-Intensity Interval Training
- ClinicalTrials.gov ID
- NCT06554665
- Acronym / sponsor ID
- HSEARS20230720002
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 5 Aug 2027 (estimated)
- Study completion
- 5 Aug 2027 (estimated)
- First posted
- 15 Aug 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.
Objectives: To investigate the effects of high-intensity interval training (HIIT) on musculoskeletal fitness in chronic stroke survivors.
Hypothesis to be tested: HIIT, performed on a recumbent stepper, will significantly enhance muscle power in chronic stroke survivors when compared with moderate-intensity continuous training (MICT) Design and subjects: Assessor-blinded, stratified, randomised, placebo-controlled clinical trial involving eligible 66 chronic stroke survivors.
Interventions: Participants will be randomly allocated to one of three groups: the HIIT group, the MICT group, or a stretching group (active control). Each group will attend sessions three times per week for 12 consecutive weeks, totaling 36 training sessions.
Main outcome measures: Assessments will be conducted at baseline, at mid-term of the intervention (week 6), at the end of the intervention (week 12), and at a 12-week follow-up (week 24). The primary outcome measure will be muscle power. Secondary outcome measures will include muscle strength, body composition, biomarkers, motor function, balance function, cardiorespiratory response, and psychosocial response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Behavioral: High-intensity Interval TrainingThe HIIT session will consist of a 3-minute warm-up, a 20-minute main exercise, and a 2-minute cool-down. The main exercise for HIIT will include ten high-intensity intervals, interspersed with ten low-intensity intervals. |
| Moderate-intensity continuous training | Active comparator | Behavioral: Moderate-Intensity Continuous TrainingThe MICT session will consist of a 3-minute warm-up, a main exercise that approximately matches the total workload of the HIIT session (lasting about 30 minutes), and a 2-minute cool-down. The intensity during the main exercise for MICT will remain below the vigorous level by progressively adjusting the workload throughout the intervention period. |
| Stretching | Active comparator | Behavioral: StretchingThe stretching group will receive 25 minutes of whole-body stretching. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and postmenopausal women aged 50-80 years
- 1-5 years following the first-ever stroke confirmed by magnetic resonance imaging or computed tomography
- Able to walk 10 meters independently with or without a walking aid
- Class I or II according to the New York Heart Association Functional Classification (no limitation or slight limitation of physical activity due to symptoms during ordinary physical activity)
Key exclusion criteria (5 listed)
- Presence of other neurological comorbidities, significant liver or renal diseases, thyroid or parathyroid diseases, rheumatoid arthritis, or a fracture within the past 6 months
- Undergoing osteoporosis treatments within the past 3 years, use of oral corticosteroids for more than 3 months within the past year, or botulinum toxin injections in the paretic lower limb within the past 6 months
- Participation in ongoing stroke rehabilitation services or structured exercise programme
- Cognitive or communication issues that could limit the ability to follow instructions
- Contraindications to HIIT, graded exercise testing, or failure to pass medical clearance from a specialist
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 TrainingThere will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions. | Behavioural | High-intensity interval training |
| Moderate-Intensity Continuous TrainingThere will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions. | Behavioural | Moderate-intensity continuous training |
| StretchingThere will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions. | Behavioural | Stretching |
Primary outcome
Change from Baseline in Muscle Power at Week 12
Time frame: Baseline and Week 12
Muscle power (watt) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 12 Level - Baseline Level)
21 secondary outcomes
Change from Baseline in Muscle Power at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Muscle Strength (Nm) at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Muscle Strength (Nm) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Muscle Strength (kg) at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Muscle Strength (kg) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Body Composition (kg) at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Body Composition (kg) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Body Composition (%) at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Body Composition (%) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Biomarkers at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Biomarkers at Week 6
Time frame: Baseline and Week 6
Change from Baseline in Motor Function at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Motor Function at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Motor Function (meters) at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Motor Function (meters) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Balance Function at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Balance Function at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Cardiopulmonary Response at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Cardiopulmonary Response at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Psychosocial Responses at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Psychosocial Responses at Week 24
Time frame: Baseline and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
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, Moderate-Intensity Continuous Training and Stretching in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 4 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Xu, PhD student (00000000, rschen.xu@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Muscle Power at Week 12 (time frame: Baseline and Week 12). 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 21 Sep 2026; AzTrials last refreshed its copy on 1 Nov 2026.