Post-Stroke FatigueNCT06846177
Graded Activity Training and Task- Oriented Training on Post-Stroke Fatigue
A study testing Graded Activity Training and Task-Oriented Training in people with Post-Stroke Fatigue, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled trial is to determine the effects of Graded Activity Training and Task Oriented Training on Fatigue in Post-Stroke Patients. Until now there is very limited work found on fatigue so this will increase quality of life in stroke patients and potentially reduce burden on healthcare… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Post-Stroke Fatigue
- What is being tested?
- Graded Activity Training and Task-Oriented Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 25 Apr 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female of age 40 to 60 years.
- Patient with both ischemic or hemorrhagic stroke.
- Patient with both right and left hemiplegia.
- Checklist Individual (CIS-F) fatigue score of 40 or more.
- Patients who had sustained a stroke more than 4 months before recruitment.
- Patients who can independently walk for 10 meters (about 33 feets)
Who cannot join
- Patients with severe comorbid health conditions (such as cardiac diseases, pulmonary diseases like COPD, Orthopedic Conditions Arthritis, joint replacements).
- Patients with uncontrolled diabetes, hypertension, Depression and Anxiety.
- Patients who are not willing to participate.
- Patient with any medications that can affect their ability to engage in physical training program like Antidepressants, Beta-Blockers, corticosteroids etc.
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Helping Hand Institute of Rehabilitation Sciences
Mansehra, KPK
Dr. AROOSA TARIQ, MS-NMPT, 03161578156, aroosa.tariq@riphah.edu.pk
Sahar Khalid, MS-NMPT*, 03449836564
About this study
Official title: Effects Of Graded Activity Training and Task-Oriented Training on Fatigue in Post-Stroke Patients
The aim of this randomized controlled trial is to determine the effects of Graded Activity Training and Task Oriented Training on Fatigue in Post-Stroke Patients. Until now there is very limited work found on fatigue so this will increase quality of life in stroke patients and potentially reduce burden on healthcare system.
Read the detailed description
Post stroke fatigue (PSF) is one of the most common outcomes of stroke. PSF is defined as "overwhelming feeling of exhaustion or tiredness" as a result of stroke PSF is an undesirable outcome by which patient's ability in study participation, adherence to medication and effectiveness of rehabilitation decrease which is unrelated to exertion, and does not typically improve with rest. Prevalence rate of PSF ranges between 25% and 85% One out of two stroke survivors experience post-stroke fatigue. The relationship between physical deconditioning and fatigue is bidirectional there was a negative relationship between fatigue and aerobic fitness in chronic stroke. PSF may arise from physical deconditioning (physical fatigue). Therefore, improving physical endurance through physical activity training could potentially reduce fatigue complaints.
The rationale of this study is to determine how task-oriented training and graded activity training effect stroke patient's levels of fatigue and to develop an improved fatigue management intervention protocol. This study will also determine effects of how both interventions affect Mobility and Gait. By doing so, we can identify a more effective PSF intervention plan, which will help reduce the burden on the healthcare system and will lessen strain on caregivers and in turn enhance patient quality of life.
- Conditions
- Post-Stroke Fatigue
- Being tested
- Graded Activity Training, Task-Oriented Training
- Keywords
- Task oriented training, Graded activity training, Post stroke, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Activity TrainingOther
4 types of progressive activities of 2 hour session two times/week with resting periods of 30 mins. Activities consist of treadmill walk ,walk on floor, core muscles exercises ,home tasks .
To ensure the proper heart rate and loads during the exercises, measurements of individual heart rate and muscle strength are taken during the first session (baseline) with HR Tracking portable device and also during the session to continuously monitor HR of the Patient. To withdraw or adjust the training intensity for each patient Borg's Scale of Perceived Exertion is used throughout the session for monitoring Training intensity of endurance, muscle training, individual's effort and exertion level.
Task-Oriented TrainingOther
4 task oriented physical fitness activities which include walk on floor, walk on inclined surface using treadmill ,sit to stand , stair climbing and descending for duration of 2 hour session with frequent breaks. Each treatment session began with 10 minutes of warm-up exercise, which consisted of passive stretching of the calf muscles, hamstring, and hip adductors. The level of difficulty and frequency for each task were gradually increased during the 6 weeks with the patients consent.10 minutes of cool down at the end of each treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Graded Activity Training | Experimental | Graded Activity Training Receives: Other: Graded Activity Training |
| Task Oriented Training | Active comparator | Task Oriented Training Receives: Other: Task-Oriented Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessment scale (FAS)
The FAS is a 10-item scale is used to evaluate symptoms of chronic fatigue. In contrast to other similar measures description of the fatigue experienced is presented for the total score of l<22 indicates normal, levels of fatigue between 22 to 34 indicates mild to moderate fatigue and score 35 or more indicates severe fatigue
Measured: 6 weeks
Secondary outcomes (2)
Timed Up and go test(Mobility)
The Timed Up and Go (TUG) is a commonly used outcome measure that is used to assess mobility and fall risk among older adults. It is a simple test that measures how quickly you can stand up, walk 10 feet, turn around, walk back, and sit down. cut off score of ≥12 seconds indicates high risk of fall.
Measured: 6 weeks
Dynamic gait index (Gait)
The DGI is 8 item scale to assess gait. The scoring of the DGI is based on a 4 point scale ranging from 0 to 3, with 0 indicating severe impairment and 3 indicating normal ability. The best performance total score is 24. A low composite DGI score thus indicates greater impairment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion25 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Stroke FatigueStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Aroosa Tariq, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846177
- Sponsor's protocol ID
- Sahar Khalid
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Graded Activity Training and Task-Oriented Training on Fatigue in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT06846177
- Acronym / sponsor ID
- Sahar Khalid
- Conditions
- Post-Stroke Fatigue
- Keywords
- Task oriented training, Graded activity training, Post stroke, Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 25 Apr 2026 (estimated)
- First posted
- 25 Feb 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.
The aim of this randomized controlled trial is to determine the effects of Graded Activity Training and Task Oriented Training on Fatigue in Post-Stroke Patients. Until now there is very limited work found on fatigue so this will increase quality of life in stroke patients and potentially reduce burden on healthcare system.
Detailed description
Post stroke fatigue (PSF) is one of the most common outcomes of stroke. PSF is defined as "overwhelming feeling of exhaustion or tiredness" as a result of stroke PSF is an undesirable outcome by which patient's ability in study participation, adherence to medication and effectiveness of rehabilitation decrease which is unrelated to exertion, and does not typically improve with rest. Prevalence rate of PSF ranges between 25% and 85% One out of two stroke survivors experience post-stroke fatigue. The relationship between physical deconditioning and fatigue is bidirectional there was a negative relationship between fatigue and aerobic fitness in chronic stroke. PSF may arise from physical deconditioning (physical fatigue). Therefore, improving physical endurance through physical activity training could potentially reduce fatigue complaints.
The rationale of this study is to determine how task-oriented training and graded activity training effect stroke patient's levels of fatigue and to develop an improved fatigue management intervention protocol. This study will also determine effects of how both interventions affect Mobility and Gait. By doing so, we can identify a more effective PSF intervention plan, which will help reduce the burden on the healthcare system and will lessen strain on caregivers and in turn enhance patient quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graded Activity Training | Experimental | Other: Graded Activity TrainingGraded Activity Training |
| Task Oriented Training | Active comparator | Other: Task-Oriented TrainingTask Oriented Training |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both male and female of age 40 to 60 years.
- Patient with both ischemic or hemorrhagic stroke.
- Patient with both right and left hemiplegia.
- Checklist Individual (CIS-F) fatigue score of 40 or more.
- Patients who had sustained a stroke more than 4 months before recruitment.
Key exclusion criteria (5 listed)
- Patients with severe comorbid health conditions (such as cardiac diseases, pulmonary diseases like COPD, Orthopedic Conditions Arthritis, joint replacements).
- Patients with uncontrolled diabetes, hypertension, Depression and Anxiety.
- Patients who are not willing to participate.
- Patient with any medications that can affect their ability to engage in physical training program like Antidepressants, Beta-Blockers, corticosteroids etc.
- Pregnant women.
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 |
|---|---|---|
| Graded Activity Training4 types of progressive activities of 2 hour session two times/week with resting periods of 30 mins. Activities consist of treadmill walk ,walk on floor, core muscles exercises ,home tasks . To ensure the proper heart rate and loads during the exercises, measurements of individual heart rate and muscle strength are taken during the first session (baseline) with HR Tracking portable device and also during the session to continuously monitor HR of the Patient. To withdraw or adjust the training intensity for each patient Borg's Scale of Perceived Exertion is used throughout the session for monitoring Training intensity of endurance, muscle training, individual's effort and exertion level. | Other | Graded Activity Training |
| Task-Oriented Training4 task oriented physical fitness activities which include walk on floor, walk on inclined surface using treadmill ,sit to stand , stair climbing and descending for duration of 2 hour session with frequent breaks. Each treatment session began with 10 minutes of warm-up exercise, which consisted of passive stretching of the calf muscles, hamstring, and hip adductors. The level of difficulty and frequency for each task were gradually increased during the 6 weeks with the patients consent.10 minutes of cool down at the end of each treatment session. | Other | Task Oriented Training |
Primary outcome
Fatigue Assessment scale (FAS)
Time frame: 6 weeks
The FAS is a 10-item scale is used to evaluate symptoms of chronic fatigue. In contrast to other similar measures description of the fatigue experienced is presented for the total score of l<22 indicates normal, levels of fatigue between 22 to 34 indicates mild to moderate fatigue and score 35 or more indicates severe fatigue
2 secondary outcomes
Timed Up and go test(Mobility)
Time frame: 6 weeks
Dynamic gait index (Gait)
Time frame: 6 weeks
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 11 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Post-Stroke Fatigue
Not yet recruiting
Development and Efficacy of a Novel, Cost-Effective Gait Training Device Utilized at Home for Stroke Survivors
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Post-Stroke Fatigue Perception Study (ReFast)
Post-stroke Fatigue
Not yet recruiting
Effects of Robotic Rehabilitation on Quality of Life, Mood, and Fatigue After Stroke
Stroke, Post-stroke Depression
Recruiting
The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation.
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Enrolling by invitationObservational study
Quest to Analyze One Thousand Humans Meditating
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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.
Dr.Aroosa Tariq, MS-NMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Activity Training and Task-Oriented Training in people with Post-Stroke Fatigue, run by Riphah International University at 1 site in Pakistan.
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 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 11 Mar 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 Pakistan. 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 Dr.Aroosa Tariq, MS-NMPT (03161578156, aroosa.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Assessment scale (FAS) (time frame: 6 weeks). 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 11 Mar 2025; AzTrials last refreshed its copy on 27 Oct 2026.