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

Primary Purpose

Stroke, Ischemic, Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High intensity Interval Training
Sponsored by
Akhtar Saeed Medical and Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Cerebrovascular accident, Treadmill Training, High-intensity interval training, Walking capacity.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Akhtar Saeed Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Rehabilitation

Combined Training (conventional rehabilitation plus high-intensity interval training):

Arm Description

Based on the functional capacity of each participant, customized Aerobic exercise plan was designed by the on-site physiotherapist.

The patients received 40 minutes of High intensity interval treadmill training in addition to their normal conventional rehabilitation.

Outcomes

Primary Outcome Measures

6 Minute walk Test
To determine the cardiorespiratory fitness of individual after sub-acute stroke.

Secondary Outcome Measures

Berg Balance test and rating scale
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.
Stroke Impact scale
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.

Full Information

First Posted
April 6, 2021
Last Updated
April 6, 2021
Sponsor
Akhtar Saeed Medical and Dental College
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1. Study Identification

Unique Protocol Identification Number
NCT04835740
Brief Title
Effects of High-intensity Interval Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke
Official Title
Effects of High-intensity Interval Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
March 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akhtar Saeed Medical and Dental College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Cerebrovascular Accident
Keywords
Cerebrovascular accident, Treadmill Training, High-intensity interval training, 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 Rehabilitation
Arm Type
Active Comparator
Arm Description
Based on the functional capacity of each participant, customized Aerobic exercise plan was designed by the on-site physiotherapist.
Arm Title
Combined Training (conventional rehabilitation plus high-intensity interval training):
Arm Type
Experimental
Arm Description
The patients received 40 minutes of High intensity interval treadmill training in addition to their normal conventional rehabilitation.
Intervention Type
Other
Intervention Name(s)
High intensity Interval Training
Intervention Description
All the participants underwent 5 weeks of High intensity interval training.
Primary Outcome Measure Information:
Title
6 Minute walk Test
Description
To determine the cardiorespiratory fitness of individual after sub-acute stroke.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Berg Balance test and rating scale
Description
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.
Time Frame
5 weeks
Title
Stroke Impact scale
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Akhtar Saeed Hospital
City
Lahore
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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