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

• Sponsor: Akhtar Saeed Medical and Dental College (Other)
• Overall Status: Completed
• CT.gov ID: NCT04835740
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 9.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic; Cerebrovascular Accident	Other: High intensity Interval Training	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: Effects of High-intensity Interval Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke
• Actual Study Start Date: Oct 5, 2020
• Actual Primary Completion Date: Nov 15, 2020
• Actual Study Completion Date: Mar 16, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 6 Minute walk Test [5 weeks]

   To determine the cardiorespiratory fitness of individual after sub-acute stroke.

Secondary Outcome Measures

1. Berg Balance test and rating scale [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.

2. Stroke Impact scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akhtar Saeed Hospital	Lahore		Pakistan

Sponsors and Collaborators

• Akhtar Saeed Medical and Dental College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Memoona Azhar, Physiotherapist, Akhtar Saeed Medical and Dental College
• ClinicalTrials.gov Identifier: NCT04835740
• Other Study ID Numbers: IRB/ASCRH/0006/2020
• First Posted: Apr 8, 2021
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memoona Azhar, Physiotherapist, Akhtar Saeed Medical and Dental College: Cerebrovascular accident; Treadmill Training; High-intensity interval training; Walking capacity.
• Additional relevant MeSH terms: Stroke; Ischemic Stroke

Study Results

No Results Posted as of Apr 8, 2021