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

April 6, 2021 updated by: Memoona Azhar, Akhtar Saeed Medical and Dental College

Hemiplegia is one of the most common sequelae of stroke. Stroke is 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
      • Lahore, Pakistan
        • Akhtar Saeed Hospital

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 75 years of age.
  • Ischemic 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.
  • Hemorrhagic Stroke.
  • 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Rehabilitation
Based on the functional capacity of each participant, customized Aerobic exercise plan was designed by the on-site physiotherapist.
Other: High intensity Interval Training
All the participants underwent 5 weeks of High intensity interval training.
Experimental: Combined Training (conventional rehabilitation plus high-intensity interval training):
The patients received 40 minutes of High intensity interval treadmill training in addition to their normal conventional rehabilitation.
Other: High intensity Interval Training
All the participants underwent 5 weeks of High intensity interval training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minute walk Test
Time Frame: 5 weeks
To determine the cardiorespiratory fitness of individual after sub-acute stroke.
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance test and rating scale
Time Frame: 5 weeks
The scale is used to determine 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
Time Frame: 5 weeks
The scale is used to measure the impairment and quality of life after stroke. The scale consists of 8 domains. In this study, only 4 domains related to hand function ,strength, mobility and Activity of daily living were used.The maximum score is 140.
5 weeks

Collaborators and Investigators

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

Sponsor

Akhtar Saeed Medical and Dental College

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)

October 5, 2020

Primary Completion (Actual)

November 15, 2020

Study Completion (Actual)

March 16, 2021

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/ASCRH/0006/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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