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

Sponsor

Government College University Faisalabad (Other)

Overall Status

Completed

CT.gov ID

NCT04377022

Collaborator

(none)

Enrollment

Location

Arms

6.3

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Stroke Cerebrovascular Accident, Acute Cerebral Stroke	Other: Combined Therapy (Aerobic Exercise in addition to conventional therapy)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2019

Actual Primary Completion Date :

May 8, 2020

Actual Study Completion Date :

Jun 10, 2020

Arms and Interventions

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 Combined therapy Conventional Therapy

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 Combined therapy Conventional Therapy

Outcome Measures

Primary Outcome Measures

6 Minute walk Test: [5 week]
To measure the physical performance of individual after stroke.

Secondary Outcome Measures

Berg Balance test and rating scale [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.
Stroke Impact scale [5 week]
To measure the impairment and quality of life after stroke. The maximum score is 140.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bin-Inam Rehabilitation Clinic Faisalabad	Faisalabad	Punjab	Pakistan	38000

Sponsors and Collaborators

Government College University Faisalabad

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ishtiaq Ahmed, Physiotherapist, Government College University Faisalabad

ClinicalTrials.gov Identifier:

NCT04377022

Other Study ID Numbers:

First Posted:

May 6, 2020

Last Update Posted:

Jul 20, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ishtiaq Ahmed, Physiotherapist, Government College University Faisalabad

Aerobic exercise

Stroke

Walking Capacity

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jul 20, 2020