Clinical trial NCT06846177: Graded Activity Training and Task- Oriented Training on Post-Stroke Fatigue
Official title: Effects Of Graded Activity Training and Task-Oriented Training on Fatigue in Post-Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Stroke Fatigue
Keywords: Task oriented training
Graded activity training
Post stroke
Fatigue
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fatigue Assessment scale (FAS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Timed Up and go test(Mobility)
timeFrame: 6 weeks
measure: Dynamic gait index (Gait)
timeFrame: 6 weeks
Other outcomes:
measure: Checklist individual strength-Fatigue (CIS-F) (Screening tool)
timeFrame: 1st week
measure: Borg's Rating of Perceived Exertion (Monitoring Tool
timeFrame: 6 weeks
Locations:
city: Mansehra
country: Pakistan
facility: Helping Hand Institute of Rehabilitation Sciences
state: KPK
Study officials:
affiliation: Riphah International University
name: Dr.Aroosa Tariq, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References: