Effects of High-intensity Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke.

Study Overview
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Brief Summary
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Stroke is one of the major cause of morbidity and mortality and the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen. The purpose of this study is to Determine the effect of high intensity speed based treadmill training on Balance, Walking capacity and quality of life in sub-acute stroke.

Official Title
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Effect of High Intensity Speed Based Treadmill Training on Balance, Walking Capacity, and Quality in People With Sub-acute Stroke.

Conditions
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Stroke

Intervention / Treatment
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* Other: Exercise Therapy
* Other: conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 40-80 years; first episode of stroke; >4 weeks of stroke onset; hemiparesis resulting from unilateral ischaemic stroke; Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively; mini-mental state examination score ≥23; ability to perform independent walking for at least five minutes with or without an assistive device (FAC=3). All patients will be determined to be in stable cardiovascular condition with a low although slightly greater risk for vigorous exercise than for apparently healthy persons (class B according to the American College of Sports Medicine [ACSM]).13 Exclusion Criteria: Participants will be excluded from the study if they had any of the following: (1) chronic cardiorespiratory or metabolic diseases; (2) severe osteoporosis; and (3) lesions pertaining to the brainstem or cerebellum; (4) having resting blood pressure above 160/100 mmHg even after taking medications; (5) cardiovascular comorbidity (aortic stenosis, depression of ST-segment, heart failure, arrhythmias, unstable angina, hypertrophic cardio-myopathy); (6) transient ischemic attack; (7) by-pass surgery in the recent three months; and (8) other musculoskeletal problems that prevented the participants from doing aerobic activity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIIT+CT<br>HIIT combined with conventional rehabilitation. | Other: Exercise Therapy<br>* High intensity speed based interval treadmill training<br>Other: conventional therapy<br>* conventional physical therapy<br>|
| Placebo Comparator: Conventional therapy<br>Conventional rehabilitation will be provided to this group of patients. | Other: conventional therapy<br>* conventional physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test | To determine the endurance after stroke | 6 weeks of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance scale | It is used to measure the Balance and stability of patient. Total score of the scale is 56. A score of < 45 indicates individuals may be at greater risk of falling. | 5 weeks | 
| Stroke Impact scale | To measure the impairment and quality of life after stroke. The maximum score is 140. | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebrovascular accident, Aerobic exercise, High intensity interval training