Investigating the effect of rehabilitation at home compared to rehabilitation at standard center on risk factors, quality of life and adherence to treatment in patients with cardiac disease
Determining the effect of cardiac rehabilitation at home on risk factors, quality of life and adherence to treatment in comparison with cardiac rehabilitation in the rehabilitation center in patients with cardiac disease
Design
Clinical trial with out control group, with parallel groups, randomized using random allocation software
Settings and conduct
The study is performed on 62 patients with heart disease referred to Afshar Hospital in Yazd, 31 patients are rehabilitated in the standard center and 31 patients are rehabilitated at home, and the effect of exercise on quality of life, risk factors and adherence to treatment is evaluated and compared.
The study is single blind in which subjects do not know what group they belong to.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 30 to 75 years, clinically stable condition
Non-inclusion criteria: Arrhythmia, uncontrolled blood pressure and diabetes, physical disability, dissatisfaction to participate in the study
Intervention groups
Intervention group 1: Exercise is done in Afshar Rehabilitation Center using treadmills and bicycles.
Intervention group 2: Doing exercise at home by walking.
Main outcome variables
Reduction of blood lipids, blood sugar, improvement of quality of life, adherence to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210927052610N1
Registration date:2021-11-28, 1400/09/07
Registration timing:retrospective
Last update:2021-11-28, 1400/09/07
Update count:0
Registration date
2021-11-28, 1400/09/07
Registrant information
Name
Najmeh Dehghanizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 9100 2550
Email address
n.dehghanizadeh@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
2020-09-22, 1399/07/01
Actual recruitment end date
2020-12-21, 1399/10/01
Trial completion date
2021-03-21, 1400/01/01
Scientific title
Investigating the effect of rehabilitation at home compared to rehabilitation at standard center on risk factors, quality of life and adherence to treatment in patients with cardiac disease
Public title
Effect of exercise in patients with cardiac disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Cardiac out put more than 40%
No ventricular arrhytmias and atrial fibrillation
Having a normal answer to exercise test
Age of 30_75 years
Clinically stable
Exclusion criteria:
Arrhythmia and uncontrolled blood pressure
Uncontrolled Diabetes
Systemic and pulmonary diseases limiting exercise
Physical disabilities and any restrictive exercise conditions
Severe valvular cardiac disease and known or suspected aortic dissection
Patient dissatisfaction
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To perform random allocation and divide the samples between two groups A (exercise in the center) and group B (exercise at home), first using random allocation software version 1, we generate a random sequence by simple random allocation method. Each of numbers 1 to 62 is assigned to the intervention group A or B. When patients are referred, the first person eligible for number 1 is taken, and the last person eligible for number 62 is assigned, respectively, and assigned to the group. A and B It is determined that in order to be blind to the random allocation of clients, the random allocation table is given to a third person who is out of the study and the researcher of the intervention group calls the third person by phone or text message before specializing.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam blvd, Professor Hesabi blvd.
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2020-08-02, 1399/05/12
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.093
Health conditions studied
1
Description of health condition studied
Cardiac patients rehabilitation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life score
Timepoint
The quality of life questionnaire sf36 is completed before the start of the rehabilitation program and after the completion of rehabilitation sessions
Method of measurement
Quality of Life Questionnaire short form 36
2
Description
Lipid profile and fasting blood glucose
Timepoint
Lipid profile and fasting blood glucose is measured before the start of the rehabilitation program and after the completion of rehabilitation sessions
Method of measurement
Level of fasting blood glucose and lipid profile is measured in labratory via Through blood sampling
3
Description
Treatment adherence
Timepoint
The treatment adherence form is completed at the beginning and end of the rehabilitation program
Method of measurement
Treatment adherence medanlo questionnaire
Secondary outcomes
1
Description
Quality of life score
Timepoint
Sf36 form is completed before exercise and after 36 exercise sessions
Method of measurement
Short Form 36 quality of life questionnaire
2
Description
Treatment adherence score
Timepoint
Modanloo questionarer form is completed before exercise and after 36 exercise sessions
Method of measurement
Treatment Adherence madanloo questionnaire
3
Description
Lipid profile level
Timepoint
Lipid profile is measured before the start of exercise and after 36 sessions of rehabilitation
Method of measurement
Blood lipids are measured in the laboratory through a blood sample
4
Description
Fasting blood glucose
Timepoint
Fasting blood sugar levels are measured before exercise and after 36 sessions of rehabilitation
Method of measurement
Fasting blood glucose is measured in the laboratory through a blood sample
5
Description
Blood pressure level
Timepoint
At the beginning of the rehabilitation program and at the end of the rehabilitation sessions
Method of measurement
Use a sphygmomanometer
Intervention groups
1
Description
Intervention group 1:Doing exercise in a standard center Using treadmills and bicycles ,3 sessions per week, each session 50 minutes, a total of 36 sessions over 3 months
Category
Rehabilitation
2
Description
Intervention group 2: Exercise at home, 30 minutes of walking daily, 5 days a week for 3 months
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar rehabilitation center
Full name of responsible person
Mohammad Reza Vafai Nasab
Street address
Afshar hospital; Jomhoori blvd
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 5011
Fax
+98 35 3525 3335
Email
Afsharhospital@ssu.ac.ir
Web page address
https://web.ssu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud mirzai
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam blvd, Professor Hesabi blvd
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3410
Fax
+98 35 3820 3414
Email
dr.n.dehghanizadeh@gmail.com
Web page address
https://web.ssu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Yazd University of Medical Sciences
Full name of responsible person
Najmeh Dehghanizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Unit 4, Floor 5, phase 5, Ahmadi Roshan residential complex, Ebne Sina blvd
City
Yazd
Province
Yazd
Postal code
8915888884
Phone
+98 35 9100 2550
Email
dr.n.dehghanizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Najmeh Dehghanizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Unit 4, Floor 5, phase 5, Ahmadi Roshan residential complex, Ebne Sina blvd
City
Yazd
Province
Yazd
Postal code
8915888884
Phone
+98 35 9100 2550
Email
dr.n.dehghanizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Najmeh Dehghanizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Unit 4, Floor 5, phase 5, Ahmadi Roshan residential complex, Ebne Sina blvd
City
Yazd
Province
Yazd
Postal code
8915888884
Phone
+98 35 9100 2550
Email
dr.n.dehghanizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Confirming the responsible person
From where data/document is obtainable
Dr najmeh dehghanizadeh
What processes are involved for a request to access data/document
By sending a request to the email of the person in charge dr.n.dehghanizadeh@gmail.com