NCT04835740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

April 6, 2021

Last Update Submit

April 6, 2021

Conditions

Keywords

Cerebrovascular accidentTreadmill TrainingHigh-intensity interval trainingWalking capacity.

Outcome Measures

Primary Outcomes (1)

  • 6 Minute walk Test

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

    5 weeks

Secondary Outcomes (2)

  • Berg Balance test and rating scale

    5 weeks

  • Stroke Impact scale

    5 weeks

Study Arms (2)

Conventional Rehabilitation

ACTIVE COMPARATOR

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

Other: High intensity Interval Training

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

EXPERIMENTAL

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

Other: High intensity Interval Training

Interventions

All the participants underwent 5 weeks of High intensity interval training.

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akhtar Saeed Hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 8, 2021

Study Start

October 5, 2020

Primary Completion

November 15, 2020

Study Completion

March 16, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations