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Effect of Aerobic Exercise Training on Balance, Walking Capacity, and Quality of Life in Sub-acute Stroke.

Primary Purpose

Cerebrovascular Stroke, Cerebrovascular Accident, Acute, Cerebral Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Combined Therapy (Aerobic Exercise in addition to conventional therapy)
Sponsored by
Government College University Faisalabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Stroke focused on measuring Aerobic exercise, Stroke, Walking Capacity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 to 75 years of age.
  • Stroke that occurred in the recent 3 months.
  • Who can walk independently or by using assistive device.
  • Have a minimum Chedoke McMaster Stroke Assessment (CMSA) leg impairment score of 3 but less than 7.

Exclusion Criteria:

  • Patients were excluded from the study if they have a stroke that occurs more than 3 months.
  • If resting blood pressure more than 160/100 even after taking medications
  • Have by-pass surgery in recent 3 months.
  • Other musculoskeletal problems which restrict the patient's ability to do aerobic activity.

Sites / Locations

  • Bin-Inam Rehabilitation Clinic Faisalabad

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional Therapy

Combined Therapy

Arm Description

In this group, Patients receive Conventional Therapy for 40 minutes daily and 5 days in a week. The training period was 5 week after the recruitment of patients.

In this group, Patients receive Aerobic exercise training in addition to conventional Physical Therapy. Patients undergoes Aerobic exercise training for 25 minutes and 3 days in a week. A total of 15 session of aerobic exercise training session was given to patient.

Outcomes

Primary Outcome Measures

6 Minute walk Test:
To measure the physical performance of individual after stroke.

Secondary Outcome Measures

Berg Balance test and rating scale
It is use o 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.
Stroke Impact scale
To measure the impairment and quality of life after stroke. The maximum score is 140.

Full Information

First Posted
May 4, 2020
Last Updated
July 16, 2020
Sponsor
Government College University Faisalabad
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1. Study Identification

Unique Protocol Identification Number
NCT04377022
Brief Title
Effect of Aerobic Exercise Training on Balance, Walking Capacity, and Quality of Life in Sub-acute Stroke.
Official Title
Effect of Aerobic Exercise Training on Balance, Walking Capacity, and Quality of Life in Sub-acute Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
May 8, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government College University Faisalabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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 Aerobic exercise training on Balance, Walking capacity and quality of life in sub-acute stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Stroke, Cerebrovascular Accident, Acute, Cerebral Stroke
Keywords
Aerobic exercise, Stroke, Walking Capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Therapy
Arm Type
No Intervention
Arm Description
In this group, Patients receive Conventional Therapy for 40 minutes daily and 5 days in a week. The training period was 5 week after the recruitment of patients.
Arm Title
Combined Therapy
Arm Type
Experimental
Arm Description
In this group, Patients receive Aerobic exercise training in addition to conventional Physical Therapy. Patients undergoes Aerobic exercise training for 25 minutes and 3 days in a week. A total of 15 session of aerobic exercise training session was given to patient.
Intervention Type
Other
Intervention Name(s)
Combined Therapy (Aerobic Exercise in addition to conventional therapy)
Intervention Description
There are two intervention arm in the study Combined therapy Conventional Therapy
Primary Outcome Measure Information:
Title
6 Minute walk Test:
Description
To measure the physical performance of individual after stroke.
Time Frame
5 week
Secondary Outcome Measure Information:
Title
Berg Balance test and rating scale
Description
It is use o 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.
Time Frame
5 week
Title
Stroke Impact scale
Description
To measure the impairment and quality of life after stroke. The maximum score is 140.
Time Frame
5 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 to 75 years of age. Stroke that occurred in the recent 3 months. Who can walk independently or by using assistive device. Have a minimum Chedoke McMaster Stroke Assessment (CMSA) leg impairment score of 3 but less than 7. Exclusion Criteria: Patients were excluded from the study if they have a stroke that occurs more than 3 months. If resting blood pressure more than 160/100 even after taking medications Have by-pass surgery in recent 3 months. Other musculoskeletal problems which restrict the patient's ability to do aerobic activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Awais bin Inam, MSOMPT
Organizational Affiliation
Government College University, Faislabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bin-Inam Rehabilitation Clinic Faisalabad
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Aerobic Exercise Training on Balance, Walking Capacity, and Quality of Life in Sub-acute Stroke.

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