StrokeNCT07041138
Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue
A study testing cognitive behavioural programme with physical training and health education with physical training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study aims to evaluate the effects of a multidimensional intervention programme on fatigue and related outcomes among people with stroke. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- cognitive behavioural programme with physical training and health education with physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- Dec 2026to Jun 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with stroke at least 6 months ago
- Fatigue Assessment Scale score ≥20
- cognitively intact
Who cannot join
- Unstable medical conditions
- with any other neurological diseases
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
The Hong Kong Polytechnic University
Hong Kong
Shamay NG, 852-2766-4889, shamay.ng@polyu.edu.hk
About this study
This study aims to evaluate the effects of a multidimensional intervention programme on fatigue and related outcomes among people with stroke.
- Conditions
- Stroke
- Being tested
- cognitive behavioural programme with physical training, health education with physical training, Usual Care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioural programme with physical trainingBehavioural
Participants will receive 7 sessions of cognitive behavioural programme over 8 weeks and have physical training at home for 8 weeks.
health education with physical trainingBehavioural
Participants will receive 7 sessions of health education over 8 weeks and have physical training at home for 8 weeks.
Usual CareBehavioural
Participants will maintain their usual life and activities for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavioural programme with physical training | Experimental | Not described Receives: Behavioral: cognitive behavioural programme with physical training |
| health education with physical training | Active comparator | Not described Receives: Behavioral: health education with physical training |
| Usual care | Other | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessment Scale
The scale scores range from 10-50, with higher score indicating higher level of fatigue.
Measured: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Secondary outcomes (4)
Pittsburgh Sleep Quality Index
The scale scores range from 0-21, with higher score indicating poorer sleep quality.
Measured: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Geriatric Depression Scale
The scale scores range from 0-15, with higher score indicating worse depressive symptoms.
Measured: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
6-minute walk test
Measured: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Cardio-ankle vascular index
Measured: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamay Ng, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041138
- Sponsor's protocol ID
- CBTPT
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue
- ClinicalTrials.gov ID
- NCT07041138
- Acronym / sponsor ID
- CBTPT
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Jun 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 evaluate the effects of a multidimensional intervention programme on fatigue and related outcomes among people with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioural programme with physical training | Experimental | Behavioral: cognitive behavioural programme with physical training |
| health education with physical training | Active comparator | Behavioral: health education with physical training |
| Usual care | Other | Behavioral: Usual Care |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with stroke at least 6 months ago
- Fatigue Assessment Scale score ≥20
- cognitively intact
Key exclusion criteria (2 listed)
- Unstable medical conditions
- with any other neurological diseases
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 |
|---|---|---|
| cognitive behavioural programme with physical trainingParticipants will receive 7 sessions of cognitive behavioural programme over 8 weeks and have physical training at home for 8 weeks. | Behavioural | cognitive behavioural programme with physical training |
| health education with physical trainingParticipants will receive 7 sessions of health education over 8 weeks and have physical training at home for 8 weeks. | Behavioural | health education with physical training |
| Usual CareParticipants will maintain their usual life and activities for 8 weeks. | Behavioural | Usual care |
Primary outcome
Fatigue Assessment Scale
Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
The scale scores range from 10-50, with higher score indicating higher level of fatigue.
4 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Geriatric Depression Scale
Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
6-minute walk test
Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Cardio-ankle vascular index
Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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 cognitive behavioural programme with physical training and health education with physical training 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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Oct 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 Shamay NG (852-2766-4889, shamay.ng@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Assessment Scale (time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention). 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 13 Oct 2026.