NCT04377022

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.

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 Dec 2019

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

December 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

May 4, 2020

Last Update Submit

July 16, 2020

Conditions

Keywords

Aerobic exerciseStrokeWalking Capacity

Outcome Measures

Primary Outcomes (1)

  • 6 Minute walk Test:

    To measure the physical performance of individual after stroke.

    5 week

Secondary Outcomes (2)

  • Berg Balance test and rating scale

    5 week

  • Stroke Impact scale

    5 week

Study Arms (2)

Conventional Therapy

NO INTERVENTION

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.

Combined Therapy

EXPERIMENTAL

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)

Interventions

There are two intervention arm in the study 1. Combined therapy 2. Conventional Therapy

Combined Therapy

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bin-Inam Rehabilitation Clinic Faisalabad

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Psychotherapy, MultipleExercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Awais bin Inam, MSOMPT

    Government College University, Faislabad

    PRINCIPAL INVESTIGATOR

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

May 4, 2020

First Posted

May 6, 2020

Study Start

December 1, 2019

Primary Completion

May 8, 2020

Study Completion

June 10, 2020

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations