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OpenTrials
Completed

NCT Number: NCT04752124

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bin Inam Rehabilitation Center.

Faisalābad, Punjab Province, 46000, Pakistan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Exercise therapy

Other

High intensity speed based interval treadmill training

Conventional Therapy

Other

conventional physical therapy

Primary outcomes

  1. 6 minute walk test

    Time frame: 6 weeks of training

    To determine the endurance after stroke

Secondary outcomes

  1. Berg Balance scale

    Time frame: 5 weeks

    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.

  2. Stroke Impact scale

    Time frame: 5 weeks

    To measure the impairment and quality of life after stroke. The maximum score is 140.

Sponsors and collaborators

Lead sponsor

Government College University Faisalabad

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2021
Registry last updated
Mar 16, 2021

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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