Comparison of the Effectiveness of Aerobic Training with Conventional Physical Therapy Treatment in improving the quality of life in Chronic Stroke Patient
this study aim is to compare the effects of Aerobic Exercise (Walking) Training and conventional physical therapy treatment in improving the quality of life in Chronic Stroke patient
Design
two study group were made after taking the sample size of 60 by using the epitol website to online calculate the sample size and then divide into two groups.The sample was recruited through convenient sampling technique and then randomly assigned to the two groups.
this will be single blinded study (assesor blind).
Settings and conduct
Data was collected from following settings,
• Haq orthopedic hospital sanda road lahore
• Hijaz hospital gulberg lahore
• Chudhary Muhammad teaching hospital lahore
• Journal hospita
our trial is single blind in which we have used the asssor blind technique through which the person who is taking the assesment after the treatment protocol is unawear
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Age 45–75years.
• Patients both Genders.
• Chronic stroke
• Lower limb should be functional atleast upto grade
• Walking independently with or without of an assistive device
Exclusion criteria
• Stroke due to subarachnoid hemorrhage
• Patients with any Systemic Illness(e.g. Rheumatism)
• Patient with Mental disability
Intervention groups
. Then participants were randomly divided into two groups.
Interventional group :
In group-A participants were given aerobic training (n=30) 30 minutes walk, 3 times a week for 12 weeks.
Group-B participants were given conventional physical therapy including stretching and strengthening with massage to involved limb For 30 minutes, 3 times a week for 12 weeks They were tested before and after treatment session by using the outcome measuring tool morticity index and SF-36( HR-QOL)
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051572N1
Registration date:2022-06-15, 1401/03/25
Registration timing:retrospective
Last update:2022-06-15, 1401/03/25
Update count:0
Registration date
2022-06-15, 1401/03/25
Registrant information
Name
gulnaz zaheer
Name of organization / entity
The superior university lahore pakistan
Country
Pakistan
Phone
+92 42 35244954
Email address
zaheergulnaz4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-28, 1400/11/08
Expected recruitment end date
2022-02-28, 1400/12/09
Actual recruitment start date
2022-03-05, 1400/12/14
Actual recruitment end date
2022-03-07, 1400/12/16
Trial completion date
2022-05-28, 1401/03/07
Scientific title
Comparison of the Effectiveness of Aerobic Training with Conventional Physical Therapy Treatment in improving the quality of life in Chronic Stroke Patient
Public title
Effects of Aerobic Training with Conventional Physical Therapy Treatment in Chronic Stroke Patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Age 45–75years
• Patients from both Genders
• Patient withChronic stroke
• Lower limb should be functional atleast upto grade 1
• Walking independently with or without of an assistive device
Exclusion criteria:
• Stroke due to subarachnoid hemorrhage
• Stroke due to subarachnoid hemorrhage
• Patients with lethargy obturant
• Patient with Mental disability
Age
From 45 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants who fulfilled the inclusion criteria were selected convenient sampling technique and were then allocated randomly to Group A and Group B using lottery method. This distribution process is hidden between participants and researchers. This was done by a research assistant who did not participate in any further research.
Blinding (investigator's opinion)
Single blinded
Blinding description
the assesor of the study is blind he will not know about the treatment protocol is given to participant and from which group the belongs
Placebo
Not used
Assignment
Parallel
Other design features
Sample size was calculated using data from previous studies, Health-related quality of life of SF-36 was used as a measure of outcome tool with µ1-µ2 and σ1² +σ2² n= (Z 1-β +Z α/2) + (σ1² + σ2²)(µ1-µ2)2Estimated Sample size was60
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Azra naheed centre for research and development Ethical Committee
Street address
17-km riwind road ,Lahore
City
Lahore
Postal code
54000
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
SU/ANCRD/IERC/55
Health conditions studied
1
Description of health condition studied
Arterial occlusion (stroke) results in infarction of brain in the distribution of that vessel. Brain infarct can be plain (80%) or hemorrhagic (20%)
ICD-10 code
163.9
ICD-10 code description
chronic stroke
Primary outcomes
1
Description
quality of life
Timepoint
befre and after the 12 weeks of treatment
Method of measurement
Health related quality of life Sf-36
Secondary outcomes
empty
Intervention groups
1
Description
Interventional Group:aerobic training walking (n=30) 30 minutes walk, 3 times a week for 12 weeks for improving morticity index and health realted quality of life
Category
Rehabilitation
2
Description
Control group: Control group:conventional physical therapy including stretching and strengthening with massage to involved limb (n=30) to improve morticity index and health related quality of life
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after de-identification will be shared
When the data will become available and for how long
When the trial has been completed after the end of August 2022 the data will be available for the future use and after the completion of trial when it get published approximately after 4 weeks in the start of october 2022 and the summry data will be available after the article get published
To whom data/document is available
It will be available to all Teaching institute and hospital for the better cure of the patient.more over it will available for the researcher as well
Under which criteria data/document could be used
Only for the research and for the benefits of public
From where data/document is obtainable
the document will be available on the following details
email: zaheergulnaz4@gmail.com
contact no :03244694034
postal address:Department of physicaltherapy The Superior University, 17 km riwid road ,Lahore
What processes are involved for a request to access data/document
application sent on email on request
zaheergulnaz4@gmail.com