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

March 15, 2021 updated by: Ishtiaq Ahmed, Government College University Faisalabad

Effect of High Intensity Speed Based Treadmill Training on Balance, Walking Capacity, and Quality in People 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.

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
      • Faisalābad, Punjab, Pakistan, 46000
        • Bin Inam Rehabilitation Center.

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: HIIT+CT
HIIT combined with conventional rehabilitation.
Other: Exercise Therapy
High intensity speed based interval treadmill training
Other: conventional therapy
conventional physical therapy
Placebo Comparator: Conventional therapy
Conventional rehabilitation will be provided to this group of patients.
Other: conventional therapy
conventional physical therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Government College University Faisalabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 7, 2020

Primary Completion (Actual)

February 27, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 555

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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