StrokeNCT07273058
Effect of HIIT on Post-Stroke Fatigue
A study testing HIIT, MICT and stretching in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study aims to investigate the effect of high-intensity interval training (HIIT) on fatigue severity among individuals with chronic stroke. Participants will be randomly assigned to the HIIT group, the moderate-intensity continuous training (MICT) group, or the stretching group (active control). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- HIIT, MICT and stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Oct 2025to 1 Oct 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 40-80 years;
- a history of ischemic stroke resulting in unilateral limb impairment 6-60 months prior to consent to participate in the pilot trial;
- a stable medical condition;
- a subjective feeling of fatigue, defined as a period of apparent fatigue, decreased energy, increased need for rest, or fatigue out of proportion to physical activity for at least 2 weeks during the past month;
- ability to communicate with the investigators and lack of significant cognitive deficits;
- able to walk for 10 meters with or without a walking aid.
Who cannot join
- An FSS score of < 4 (20);
- other neurological conditions;
- other musculoskeletal comorbidities that would prevent safe participation in exercises;
- a medical diagnosis of significant cardiovascular, pulmonary, or metabolic disease(s);
- signs or symptoms indicative of significant cardiovascular, pulmonary, or metabolic disease(s) during the previous 3 months;
- severe lower limb spasticity (Ashworth Scale score ≥ 3);
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- Botulinum toxin use in the affected lower limb within the past six months;
- current or previous use of drugs intended to resolve post-stroke fatigue;
- active engagement in other stroke rehabilitation trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fong Sze Chung contact
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Kowloon
Meizhen Huang, +852 0000000, mei-zhen.huang@polyu.edu.hk
About this study
Official title: Effect of High-Intensity Interval Training Intervention on Post-Stroke Fatigue in Chronic Stroke Survivors: A Pilot Randomized Clinical Trial
This study aims to investigate the effect of high-intensity interval training (HIIT) on fatigue severity among individuals with chronic stroke. Participants will be randomly assigned to the HIIT group, the moderate-intensity continuous training (MICT) group, or the stretching group (active control). Each group will participate in supervised exercise sessions three times per week over a 12-week period, totaling 36 sessions. Outcome assessments will be conducted at baseline, mid-intervention (week 6), post-intervention (week 12), and follow-up (week 20). The primary outcome will be fatigue severity. Secondary outcomes will include inflammatory biomarkers and additional health-related indicators.
- Conditions
- Stroke
- Being tested
- HIIT, MICT, stretching
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
The HIIT intervention will consist of a 3-minute warm-up, a 25-minute main exercise, and a 2-minute cool-down. The main exercise will include four 4-minute high-intensity intervals, each interspersed with a 3-minute low-intensity recovery period. Participants will attend three supervised sessions per week over a 12-week period.
MICTBehavioural
The MICT intervention will include a 3-minute warm-up, 25 minutes of continuous exercise performed at a moderate intensity, and a 2-minute cool-down. Participants will attend three supervised sessions per week over a 12-week period.
stretchingBehavioural
The stretching intervention will consist of 30 minutes of whole-body stretching. Participants will attend three sessions per week over a 12-week period.
| Study group | Role | What they receive |
|---|---|---|
| HIIT | Experimental | Not described Receives: Behavioral: HIIT |
| MICT | Active comparator | Not described Receives: Behavioral: MICT |
| Stretching | Active comparator | Not described Receives: Behavioral: stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility rate (%)
Measured: Through study completion, an average of 12 weeks.
Recruitment rate (number of participants per month)
Measured: Through study completion, an average of 12 weeks.
Compliance with HIIT (%)
Measured: From baseline to week 12
Fidelity to the HIIT protocol (%)
Measured: From baseline to week 12
Retention of the intervention (%)
Measured: From baseline to week 12
Adverse events (number of events)
Measured: From baseline to week 12
Acceptability (qualitative)
Measured: At week 12
Secondary outcomes (4)
Fatigue Severity Scale (FSS)
The FSS consists of 9 items rated on a 7-point Likert scale from 1 (highly disagree) to 7 (highly agree). Higher scores indicate greater fatigue severity.
Measured: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Multidimensional Fatigue Inventory (MDI)
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report questionnaire designed to assess fatigue across five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity. Each subscale contains 4 items rated on a 5-point Likert scale. Higher scores indicate greater fatigue. The total score ranges from 20 to 100.
Measured: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Short Form-36 Health Survey (SF-36)
The SF-36 includes 36 items and one additional item assessing perceived change in health over time. Each domain is scored on a scale from 0 to 100, with higher scores indicating better health status.
Measured: Blinded assessors will conduct evaluations at baseline, week 6, and week 12.
Inflammatory biomarkers
Inflammatory biomarkers will be quantified using enzyme-linked immunosorbent assay (ELISA) kits obtained from commercial suppliers, following the manufacturer's instructions.
Measured: Blinded assessors will conduct evaluations at baseline, week 6, and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 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.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr HUANG Mei Zhen, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273058
- Sponsor's protocol ID
- HSEARS20241002001
- Status last verified
- Nov 2025
- First submitted
- 16 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Interval Training Intervention on Post-Stroke Fatigue in Chronic Stroke Survivors: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07273058
- Acronym / sponsor ID
- HSEARS20241002001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 9 Dec 2025 (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.
This study aims to investigate the effect of high-intensity interval training (HIIT) on fatigue severity among individuals with chronic stroke. Participants will be randomly assigned to the HIIT group, the moderate-intensity continuous training (MICT) group, or the stretching group (active control). Each group will participate in supervised exercise sessions three times per week over a 12-week period, totaling 36 sessions. Outcome assessments will be conducted at baseline, mid-intervention (week 6), post-intervention (week 12), and follow-up (week 20). The primary outcome will be fatigue severity. Secondary outcomes will include inflammatory biomarkers and additional health-related indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIIT | Experimental | Behavioral: HIIT |
| MICT | Active comparator | Behavioral: MICT |
| Stretching | Active comparator | Behavioral: stretching |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 40-80 years;
- a history of ischemic stroke resulting in unilateral limb impairment 6-60 months prior to consent to participate in the pilot trial;
- a stable medical condition;
- a subjective feeling of fatigue, defined as a period of apparent fatigue, decreased energy, increased need for rest, or fatigue out of proportion to physical activity for at least 2 weeks during the past month;
- ability to communicate with the investigators and lack of significant cognitive deficits;
Key exclusion criteria (9 listed)
- An FSS score of < 4 (20);
- other neurological conditions;
- other musculoskeletal comorbidities that would prevent safe participation in exercises;
- a medical diagnosis of significant cardiovascular, pulmonary, or metabolic disease(s);
- signs or symptoms indicative of significant cardiovascular, pulmonary, or metabolic disease(s) during the previous 3 months;
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 |
|---|---|---|
| HIITThe HIIT intervention will consist of a 3-minute warm-up, a 25-minute main exercise, and a 2-minute cool-down. The main exercise will include four 4-minute high-intensity intervals, each interspersed with a 3-minute low-intensity recovery period. Participants will attend three supervised sessions per week over a 12-week period. | Behavioural | HIIT |
| MICTThe MICT intervention will include a 3-minute warm-up, 25 minutes of continuous exercise performed at a moderate intensity, and a 2-minute cool-down. Participants will attend three supervised sessions per week over a 12-week period. | Behavioural | MICT |
| stretchingThe stretching intervention will consist of 30 minutes of whole-body stretching. Participants will attend three sessions per week over a 12-week period. | Behavioural | Stretching |
Primary outcome
Eligibility rate (%)
Time frame: Through study completion, an average of 12 weeks.
Recruitment rate (number of participants per month)
Time frame: Through study completion, an average of 12 weeks.
Compliance with HIIT (%)
Time frame: From baseline to week 12
Fidelity to the HIIT protocol (%)
Time frame: From baseline to week 12
Retention of the intervention (%)
Time frame: From baseline to week 12
Adverse events (number of events)
Time frame: From baseline to week 12
Acceptability (qualitative)
Time frame: At week 12
4 secondary outcomes
Fatigue Severity Scale (FSS)
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Multidimensional Fatigue Inventory (MDI)
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Short Form-36 Health Survey (SF-36)
Time frame: Blinded assessors will conduct evaluations at baseline, week 6, and week 12.
Inflammatory biomarkers
Time frame: Blinded assessors will conduct evaluations at baseline, week 6, and week 12.
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 9 Dec 2025.
- 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.
Fong Sze Chung contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT, MICT 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 6 inclusion and 9 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 9 Dec 2025. 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 Mei Zhen Prof. Huang (+852 00000000, mei-zhen.huang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rate (%) (time frame: Through study completion, an average of 12 weeks.). The study lists 7 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 9 Dec 2025.