Graded Activity Training and Task- Oriented Training on Post-Stroke Fatigue

NCT ID: NCT06846177

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-04-25

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.

Conditions

Post-Stroke Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Graded Activity Training

Graded Activity Training

Group Type: EXPERIMENTAL

Graded Activity Training

Intervention Type: OTHER

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 Training

Task Oriented Training

Group Type: ACTIVE_COMPARATOR

Task-Oriented Training

Intervention Type: OTHER

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.

Interventions

Graded Activity Training

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.

Intervention Type: OTHER

Task-Oriented Training

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr.Aroosa Tariq, MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Helping Hand Institute of Rehabilitation Sciences

Mansehra, KPK, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Dr.Aroosa Tariq, MS-NMPT

Role: CONTACT

aroosa.tariq@riphah.edu.pk

03161578156

Facility Contacts

Dr. AROOSA TARIQ, MS-NMPT

Role: primary

aroosa.tariq@riphah.edu.pk

03161578156

Sahar Khalid, MS-NMPT*

Role: backup

03449836564

Other Identifiers

Sahar Khalid

Identifier Type: -

Identifier Source: org_study_id