The aim of this study will be to compare the energy expenditure during physical activity of the patients of myocardial infarction –IV having home based and supervised cardiac rehabilitation.
Design
Rendomized clinical trial
Settings and conduct
Younas Hospital Daska
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with age range greater then 18.
Both males and females.
Patients clinically diagnosed with MI.
Patient who will give consent to abide by treatment .
Exclusion criteria:
Pregnant females
Unstble angina.
Any respiratory disease.
History of rib fracture.
Intervention groups
Group 1: patients will be treated with supervised cardiac rehabilitation program.
Group 2: patients will be treated with home based exercise program.
Main outcome variables
effect of home based and clinical exercise on physical activity of MI IV patients.
General information
Reason for update
Acronym
MI , CRP
IRCT registration information
IRCT registration number:IRCT20191117045462N8
Registration date:2022-05-09, 1401/02/19
Registration timing:retrospective
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-04, 1400/10/14
Expected recruitment end date
2022-04-05, 1401/01/16
Actual recruitment start date
2022-01-05, 1400/10/15
Actual recruitment end date
2022-04-01, 1401/01/12
Trial completion date
2022-05-02, 1401/02/12
Scientific title
Comparison of home based and supervised cardiac rehabilitation program on physical activity in Myocardial Infarction - IV patients.
Public title
Comparison of home based and supervised cardiac rehabilitation program on physical activity in Myocardial Infarction - IV patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both males and females .
patient with age range greater then 18
Patients clinically diagnosed with MI-IV.
Patients who will give consent to abide by treatment.
Exclusion criteria:
Pregnant females
Unstable angina
Any respiratory disease
MI-I , MI-II , MI-III .
Rib fracture.
Red flags like ; fever , night sweats , malaise.
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be recruited in the study through a convenient sampling technique and then will be randomly
assigned to each group through Random Sampling sealed opaque enveloped. Labeled as 1 for group G1 and 2 for group G2. Half enveloped will be labeled with 1 and a half with labeled 2. If a patient gets the envelope with label 1 then will be treated in group G1, and if a patient gets the envelope with label 2 that will be treated in group G2.
Blinding (investigator's opinion)
Single blinded
Blinding description
participants will be blind . they will only get treatment .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah college of rehabilitation & Allied Health Sciences
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Approval date
2022-01-05, 1400/10/15
Ethics committee reference number
RCR&AHS/REC/MS-OMPT/S19/003
Health conditions studied
1
Description of health condition studied
Mayocardial Infarction IV
ICD-10 code
I21.4
ICD-10 code description
Non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Pulse oximeter will be used to monitor heart rate and oxygen saturation level. Mercury sphygmomanometer will be used to measure blood pressure.
Timepoint
pre and post treatment
Method of measurement
Pulse oximeter and sphygmomanometer
Secondary outcomes
1
Description
Accelerometer will be used to measure energy expenditure of patients during cardiac rehabilitation. IPAQ is a 27-item self-reported measure of physical activity
Timepoint
pre and post treatment
Method of measurement
Accelerometer and IPAQ tool
Intervention groups
1
Description
Intervention group: home based rehabilitation program in IV Mayocardial ifraction
Category
Treatment - Other
2
Description
Intervention group: Supervised clinical rehabilitation in IV Mayocardial Infarction
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Rida Fatima
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
ridadpt1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Rida Fatima
Street address
28-M,Quaid-e Azam, Industrial Estate kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
ridadpt1@gmail.com
Grant name
Riphah International university
Grant code / Reference number
Educational
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International university
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah international university, QIE Campus, Lahore
Full name of responsible person
Wajeeha Zia
Position
physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Madar e millat road
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 21 86705503
Email
wajeeha_z@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation and Research
Street address
28-M,Quaid-e Azam, Industrial Estate kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Rida Fatima
Position
physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation
Street address
House no 8/707 Muhallah haq pura near civil hospital Daska
City
Daska
Province
punjab
Postal code
51010
Phone
+92 333 0484989
Email
ridadpt1@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no plan to make it available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available