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

July 16, 2020 updated by: Ishtiaq Ahmed, Government College University Faisalabad

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • Bin-Inam Rehabilitation Clinic Faisalabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Conventional Therapy
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.
EXPERIMENTAL: Combined Therapy
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.
Other: Combined Therapy (Aerobic Exercise in addition to conventional therapy)

There are two intervention arm in the study

  1. Combined therapy
  2. Conventional Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minute walk Test:
Time Frame: 5 week
To measure the physical performance of individual after stroke.
5 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance test and rating scale
Time Frame: 5 week
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.
5 week
Stroke Impact scale
Time Frame: 5 week
To measure the impairment and quality of life after stroke. The maximum score is 140.
5 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Government College University Faisalabad

Investigators

  • Principal Investigator: Awais bin Inam, MSOMPT, Government College University, Faislabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2019

Primary Completion (ACTUAL)

May 8, 2020

Study Completion (ACTUAL)

June 10, 2020

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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