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

Sponsor
Government College University Faisalabad (Other)
Overall Status
Completed
CT.gov ID
NCT04752124
Collaborator
(none)
50
1
2
4.2
11.9

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 high intensity speed based treadmill training on Balance, Walking capacity and quality of life in sub-acute stroke.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise Therapy
  • Other: 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 High Intensity Speed Based Treadmill Training on Balance, Walking Capacity, and Quality in People With Sub-acute Stroke.
Actual Study Start Date :
Nov 7, 2020
Actual Primary Completion Date :
Feb 27, 2021
Actual Study Completion Date :
Mar 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 6 minute walk test [6 weeks of training]

    To determine the endurance after stroke

Secondary Outcome Measures

  1. Berg Balance scale [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.

  2. Stroke Impact scale [5 weeks]

    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 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bin Inam Rehabilitation Center. Faisalābad Punjab Pakistan 46000

Sponsors and Collaborators

  • Government College University Faisalabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ishtiaq Ahmed, Physiotherapist, Government College University Faisalabad
ClinicalTrials.gov Identifier:
NCT04752124
Other Study ID Numbers:
  • 555
First Posted:
Feb 12, 2021
Last Update Posted:
Mar 16, 2021
Last Verified:
Mar 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 Ishtiaq Ahmed, Physiotherapist, Government College University Faisalabad
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2021