StrokeNCT07824570
Effects of I-STROKEFIT+ on Physical Fitness Among Community-Dwelling Stroke Survivors: A Pilot RCT
A study testing Physical fitness and Self-Management and Patient Education in people with Stroke and Chronic Stroke Patient, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
This pilot randomized controlled study will evaluate whether a 12-week integrated home-based physical fitness and self-management programme (i-StrokeFit+) can improve physical fitness and physical activity among community-dwelling stroke survivors. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Stroke, Chronic Stroke Patient, Stroke (6 Months or More After Onset)
- What is being tested?
- Physical fitness and Self-Management and Patient Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 5 Oct 2023to 20 Jul 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 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who had been diagnosed with stroke more than 6 months since the accident occurred.
- The age ranged from 20 to 59 years.
- Able to ambulate with or without an assistive device with a score of (Functional Ambulatory Category ≥3).
- Presented with the National Institutes of Health Stroke Scale (NIHSS) score 5-14 (mild to moderately severe)
- Participants who have a sedentary lifestyle according to the Stroke Physical Activity Questionnaire
- Participants presented with normal cognitive function
- Able to understand and speak the Malay or English language.
Who cannot join
- Participants presented with aphasia
- Participants with uncontrolled blood pressure
- Participants who have contraindications towards submaximal exercise testing, such as active inflammatory heart disease or acute myocardial infarction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Integrated Home-Based Physical Fitness and Self-Management Programme (I-STROKEFIT+) on Physical Fitness Among Community-Dwelling Stroke Survivors: A Pilot Randomised Controlled Trial
This pilot randomized controlled study will evaluate whether a 12-week integrated home-based physical fitness and self-management programme (i-StrokeFit+) can improve physical fitness and physical activity among community-dwelling stroke survivors. The programme combines aerobic exercise, strengthening exercises, stretching, and self-management strategies. The study hypothesizes that participants receiving i-StrokeFit+ will demonstrate greater improvements in physical fitness and physical activity compared with participants receiving stroke education and simple stretching exercises.
Read the detailed description
This pilot randomised controlled study evaluated the effects of an integrated home-based physical fitness and self-management programme (i-StrokeFit+) among community-dwelling stroke survivors. The study was conducted to determine whether a structured home-based programme combining physical fitness training with self-management support could improve physical fitness and physical activity compared with an educational control programme.
Participants who met the study requirements were screened, provided informed consent, and underwent baseline assessment before being randomly allocated to either the i-StrokeFit+ intervention group or the control group. The intervention commenced with a 2-week supervised adaptation phase to familiarise participants with the exercise programme, ensure appropriate exercise technique, and support safe progression before transitioning to home-based training.
Following the adaptation phase, participants in the i-StrokeFit+ group continued a structured 12-week home-based exercise programme incorporating aerobic exercise, resistance exercise, mixed aerobic and resistance training, and self-management support. Exercise training was progressively adjusted according to frequency, intensity, duration, sets, and repetitions. Brisk walking was used for aerobic training, while resistance bands and bodyweight exercises were used for resistance training. Participants were provided with educational and self-management materials, including guidance on stroke management, nutrition, physical activity, lifestyle, exercise scheduling, and exercise monitoring. Exercise adherence was supported through an exercise handbook, checklist or diary, and activity monitoring devices.
Participants in the control group received stroke education and simple stretching exercises. The control programme did not include a structured progressive physical fitness training programme.
Assessments were conducted at baseline, Week 6, and Week 12. The study used a single-blinded assessment approach, with outcome assessments conducted at the participating study sites. The study was designed as a pilot randomised controlled trial to evaluate the preliminary effects of the i-StrokeFit+ programme and to provide information for future research involving a larger sample.
- Conditions
- Stroke, Chronic Stroke Patient, Stroke (6 Months or More After Onset), Community Dwelling, CVA, Cerebrovascular Accident (CVA)
- Being tested
- Physical fitness and Self-Management, Patient Education
- Keywords
- stroke, physical fitness, home-based, rehabilitation, physiotherapy, neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical fitness and Self-ManagementOther
A structured home-based exercise and self-management programme designed to improve physical fitness among community-dwelling stroke survivors. The programme included aerobic exercise, resistance exercise, mixed training, and self-management education, following a 2-week supervised adaptation phase before home-based training.
Patient EducationOther
An educational programme providing information about stroke, including its symptoms, risk factors, pathophysiology, and management, together with simple stretching exercises. The stretching exercises were unstructured and unsupervised.
| Study group | Role | What they receive |
|---|---|---|
| I-STROKEFIT+ | Experimental | Participants received the i-StrokeFit+ programme, an integrated physical fitness and self-management intervention. The programme included aerobic exercise, resistance exercise, mixed aerobic and resistance training, and self-management education. Participants first completed a 2-week supervised adaptation phase before continuing the structured exercise programme in a home-based setting. Exercise was progressively adjusted according to frequency, intensity, duration, sets, and repetitions. Participants also received materials to support exercise scheduling, monitoring, and adherence. Receives: Other: Physical fitness and Self-Management |
| Control Group | Active comparator | Participants received a stroke education programme covering stroke-related information, including symptoms, risk factors, pathophysiology, and management. Participants were also provided with simple stretching exercises. The control programme did not include a structured progressive physical fitness training programme, and the stretching exercises were unstructured and unsupervised Receives: Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 6-Minute Walk Test
The 6-Minute Walk Test (6MWT) is a functional walking test used to assess cardiorespiratory fitness and walking endurance. Participants are instructed to walk as far as possible along a designated walking course for 6 minutes, and the total distance walked is recorded in metres.
Measured: Baseline, 6 Week and 12 Week
Handheld Dyanamometer Muscle Strength
The handheld dynamometer is used to assess isometric muscle strength. Muscle strength is measured on the affected side for the biceps, triceps, quadriceps, and hamstrings, with the maximum force recorded in kilograms-force (kgf).
Measured: Baseline, 6 Week and 12 Week
30 Seconds Chair Stand Test
The 30-Second Chair Stand Test (30-SCST) is a functional test used to assess lower-limb muscle strength and endurance. Participants are instructed to stand up from a chair and sit down as many times as possible within 30 seconds. The total number of completed repetitions is recorded.
Measured: Baseline, 6 Week and 12 Week
Secondary outcomes (3)
10 Meter Walk Test
The 10-Meter Walk Test (10MWT) is a functional walking test used to assess walking performance. Participants are instructed to walk at their comfortable walking speed along a 10-meter walkway, and their walking speed is calculated and recorded in metres per second (m/s).
Measured: Baseline, 6 Week and 12 Week
Stroke Physical Activity Questionnaire
Stroke Physical Activity Questionnaire (SPAQ): Total time spent participating in physical activities during the previous 7 days, reported as minutes per week. The questionnaire assesses low, moderate, and vigorous physical activities. Scores are expressed as minutes per week, with higher values indicating greater physical activity
Measured: Baseline, 6 Week and 12 Week
Stroke Specific Quality of Life
Stroke-Specific Quality of Life Scale (SS-QOL): A 49-item, stroke-specific measure of health-related quality of life across 12 domains. Total scores range from 49 to 245, with higher scores indicating better quality of life and functioning.
Measured: Baseline, 6 Week and 12 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start5 Oct 2023
- Primary completion20 Jul 2025
- Study completion20 Jul 2025
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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Rasydan Bin Ramlan, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824570
- Sponsor's protocol ID
- FRGS
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because the study was conducted as a master's research project and the individual-level data contain participant information subject to confidentiality and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Integrated Home-Based Physical Fitness and Self-Management Programme (I-STROKEFIT+) on Physical Fitness Among Community-Dwelling Stroke Survivors: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07824570
- Acronym / sponsor ID
- FRGS
- Conditions
- Stroke, Chronic Stroke Patient, Stroke (6 Months or More After Onset), Community Dwelling, CVA, Cerebrovascular Accident (CVA)
- Keywords
- stroke, physical fitness, home-based, rehabilitation, physiotherapy, neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 17 Sep 2026 (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 pilot randomized controlled study will evaluate whether a 12-week integrated home-based physical fitness and self-management programme (i-StrokeFit+) can improve physical fitness and physical activity among community-dwelling stroke survivors. The programme combines aerobic exercise, strengthening exercises, stretching, and self-management strategies. The study hypothesizes that participants receiving i-StrokeFit+ will demonstrate greater improvements in physical fitness and physical activity compared with participants receiving stroke education and simple stretching exercises.
Detailed description
This pilot randomised controlled study evaluated the effects of an integrated home-based physical fitness and self-management programme (i-StrokeFit+) among community-dwelling stroke survivors. The study was conducted to determine whether a structured home-based programme combining physical fitness training with self-management support could improve physical fitness and physical activity compared with an educational control programme.
Participants who met the study requirements were screened, provided informed consent, and underwent baseline assessment before being randomly allocated to either the i-StrokeFit+ intervention group or the control group. The intervention commenced with a 2-week supervised adaptation phase to familiarise participants with the exercise programme, ensure appropriate exercise technique, and support safe progression before transitioning to home-based training.
Following the adaptation phase, participants in the i-StrokeFit+ group continued a structured 12-week home-based exercise programme incorporating aerobic exercise, resistance exercise, mixed aerobic and resistance training, and self-management support. Exercise training was progressively adjusted according to frequency, intensity, duration, sets, and repetitions. Brisk walking was used for aerobic training, while resistance bands and bodyweight exercises were used for resistance training. Participants were provided with educational and self-management materials, including guidance on stroke management, nutrition, physical activity, lifestyle, exercise scheduling, and exercise monitoring. Exercise adherence was supported through an exercise handbook, checklist or diary, and activity monitoring devices.
Participants in the control group received stroke education and simple stretching exercises. The control programme did not include a structured progressive physical fitness training programme.
Assessments were conducted at baseline, Week 6, and Week 12. The study used a single-blinded assessment approach, with outcome assessments conducted at the participating study sites. The study was designed as a pilot randomised controlled trial to evaluate the preliminary effects of the i-StrokeFit+ programme and to provide information for future research involving a larger sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-STROKEFIT+ | Experimental | Other: Physical fitness and Self-ManagementParticipants received the i-StrokeFit+ programme, an integrated physical fitness and self-management intervention. The programme included aerobic exercise, resistance exercise, mixed aerobic and resistance training, and self-management education. Participants first completed a 2-week supervised adaptation phase before continuing the structured exercise programme in a home-based setting. Exercise was progressively adjusted according to frequency, intensity, duration, sets, and repetitions. Participants also received materials to support exercise scheduling, monitoring, and adherence. |
| Control Group | Active comparator | Other: Patient EducationParticipants received a stroke education programme covering stroke-related information, including symptoms, risk factors, pathophysiology, and management. Participants were also provided with simple stretching exercises. The control programme did not include a structured progressive physical fitness training programme, and the stretching exercises were unstructured and unsupervised |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants who had been diagnosed with stroke more than 6 months since the accident occurred.
- The age ranged from 20 to 59 years.
- Able to ambulate with or without an assistive device with a score of (Functional Ambulatory Category ≥3).
- Presented with the National Institutes of Health Stroke Scale (NIHSS) score 5-14 (mild to moderately severe)
- Participants who have a sedentary lifestyle according to the Stroke Physical Activity Questionnaire
Key exclusion criteria (3 listed)
- Participants presented with aphasia
- Participants with uncontrolled blood pressure
- Participants who have contraindications towards submaximal exercise testing, such as active inflammatory heart disease or acute myocardial infarction.
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 |
|---|---|---|
| Physical fitness and Self-ManagementA structured home-based exercise and self-management programme designed to improve physical fitness among community-dwelling stroke survivors. The programme included aerobic exercise, resistance exercise, mixed training, and self-management education, following a 2-week supervised adaptation phase before home-based training. | Other | I-STROKEFIT+ |
| Patient EducationAn educational programme providing information about stroke, including its symptoms, risk factors, pathophysiology, and management, together with simple stretching exercises. The stretching exercises were unstructured and unsupervised. | Other | Control Group |
Primary outcome
The 6-Minute Walk Test
Time frame: Baseline, 6 Week and 12 Week
The 6-Minute Walk Test (6MWT) is a functional walking test used to assess cardiorespiratory fitness and walking endurance. Participants are instructed to walk as far as possible along a designated walking course for 6 minutes, and the total distance walked is recorded in metres.
Handheld Dyanamometer Muscle Strength
Time frame: Baseline, 6 Week and 12 Week
The handheld dynamometer is used to assess isometric muscle strength. Muscle strength is measured on the affected side for the biceps, triceps, quadriceps, and hamstrings, with the maximum force recorded in kilograms-force (kgf).
30 Seconds Chair Stand Test
Time frame: Baseline, 6 Week and 12 Week
The 30-Second Chair Stand Test (30-SCST) is a functional test used to assess lower-limb muscle strength and endurance. Participants are instructed to stand up from a chair and sit down as many times as possible within 30 seconds. The total number of completed repetitions is recorded.
3 secondary outcomes
10 Meter Walk Test
Time frame: Baseline, 6 Week and 12 Week
Stroke Physical Activity Questionnaire
Time frame: Baseline, 6 Week and 12 Week
Stroke Specific Quality of Life
Time frame: Baseline, 6 Week and 12 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because the study was conducted as a master's research project and the individual-level data contain participant information subject to confidentiality and data protection requirements.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical fitness and Self-Management and Patient Education in people with Stroke and Chronic Stroke Patient, run by Universiti Teknologi Mara at 1 site in Malaysia.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 17 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 6-Minute Walk Test (time frame: Baseline, 6 Week and 12 Week). 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 17 Sep 2026.