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

ConditionPost-Stroke Fatigue

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-60

SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Graded Activity Training
Other intervention
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 intervention
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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Graded Activity TrainingExperimental treatment 1 intervention

Group B: Task Oriented TrainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

6 weeks

Secondary outcomes

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.

Time frame

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

Time frame

6 weeks

Other outcomes

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

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

Time frame

1st week

Borg's Rating of Perceived Exertion (Monitoring Tool

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.

Time frame

6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riphah International University

Lead sponsor

Source ClinicalTrials.gov

Apply now