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NCT Number: NCT06846177

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

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.

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Key information

Conditions

Post-stroke Fatigue Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helping Hand Institute of Rehabilitation Sciences

Mansehra, KPK, Pakistan

Location status: Recruiting

Location contact

Dr. AROOSA TARIQ, MS-NMPT

CONTACT

[email protected]

03161578156

Sahar Khalid, MS-NMPT*

CONTACT

03449836564

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Graded Activity Training

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Timed Up and go test(Mobility)

    Time frame: 6 weeks

    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.

  2. Dynamic gait index (Gait)

    Time frame: 6 weeks

    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

Other outcomes

  1. Checklist individual strength-Fatigue (CIS-F) (Screening tool)

    Time frame: 1st week

    a 20-items questionnaire for fatigue and is used in various illnesses, including Myalgic encephalomyelitis/chronic fatigue syndrome CSF.

    4 components in the remaining 20 questions. These were easy to interpret and were called Subjective Fatigue 8 items, Concentration 5 items, Motivation 4 items, Physical activity 3 items. A higher score indicates more fatigue. cutt off score 40 or above will be selected for inclusion criteria

  2. Borg's Rating of Perceived Exertion (Monitoring Tool

    Time frame: 6 weeks

    The Borg Rating of Perceived Exertion (RPE) scale is a tool for measuring an individual's effort and exertion, breathlessness and fatigue during physical work .The Borg RPE scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr.Aroosa Tariq, MS-NMPT

CONTACT

[email protected]

03161578156

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects Of Graded Activity Training and Task-Oriented Training on Fatigue in Post-Stroke Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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