Determining and comparing the rehabilitation of CABG patients through telerehabilitation and in-hospital rehabilitation on clinical outcomes
Design
non-randomized clinical trial
30 patients in each group
Settings and conduct
The study will assess the telerehabilitation of patients from the Rajaei Cardiovascular Institute. Patients will be divided into two groups based on their entry criteria and preferences. The home base group will receive rehabilitation at home 4 weeks after CABG and will attend the rehabilitation department for two sessions. They will then continue rehabilitation at home using live communication with a nurse, participating in two sessions per week, each lasting 1- 2 hours. they will receive further training from the rehabilitation team through the same system. The control group will undergo rehabilitation at rehabilitation department. After 24 rehabilitation sessions in both groups, the study will compare the outcomes.
Participants/Inclusion and exclusion criteria
CABG patients
lives in Tehran
EuroSCORE 0-5
Lack of movement problems
No major complications
Hemoglobin ≥ 8.5
low and medium-risk patients
have a caregiver at home
literacy patient
Non-entry criteria:
Insulin-dependent diabetes
Overt chronic respiratory insufficiency
Major complication of Cardiac surgery
Intervention groups
home-based rehabilitation patients
Main outcome variables
number of Hospital readmissions in the period of the rehabilitation period
rest and peak spo2 in 6MWT before and after intervention
6MWD distance before and after intervention
LVEF (%): First postoperative echocardiography compared to echocardiography after the rehabilitation period
Hemoglobin (mg/dL): Discharge time Hemoglobin compared to Hemoglobin after the rehabilitation period
patient’s satisfaction at the end of the rehabilitation period (0-10)
quality of life-based on the SF36 questioner
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240727062553N1
Registration date:2024-08-12, 1403/05/22
Registration timing:prospective
Last update:2024-08-12, 1403/05/22
Update count:0
Registration date
2024-08-12, 1403/05/22
Registrant information
Name
Shiva Khaleghparast
Name of organization / entity
Rajaie Cardiovasclular Medical and Research Institude
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2645
Email address
khaleghparast.sh@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of telemedicine-based rehabilitation on clinical outcomes of patients undergoing coronary artery bypass grafting (CABG)
Public title
The impact of telemedicine-based rehabilitation on clinical outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
EuroSCORE 0-5
No major complications Cardiac surgery (need for reoperation after surgery due to bleeding or tamponade), the occurrence of mediastinitis, long-term hospitalization in ICU for more than 5 days, long-term intubation in ICU (more than 24 hours), long-term hospitalization in Hospital (more than 12 days)
Lack of movement problems in upper and lower limbs due to previous CVA or following surgery
Hemoglobin ≥ 8.5
CABG patients
The patient lives in Tehran
All patients are required to have a caregiver at home
The patient or the patient's companion must have the ability to learn to work with the Polar device
Low and medium irsk patients base on AACVPR criteria
The patient should be literate
Exclusion criteria:
Insulin-dependent diabetes
Overt chronic respiratory insufficiency
Major complication of Cardiac surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 cardiovascular Medical and Research Institue
Street address
Valiasr St. - Niayesh highway intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2024-06-15, 1403/03/26
Ethics committee reference number
IR.RHC.REC.1403.029
Health conditions studied
1
Description of health condition studied
Coronary Artery bypass Graft patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemoglobin
Timepoint
: First postoperative Hemoglobin compared to Hemoglobin after the rehabilitation period
Method of measurement
Through testing the amount of hemoglobin in the laboratory of the institute with a specific kit
2
Description
number of Hospital readmissions in period of the rehabilitation period
Timepoint
From the beginning of the rehabilitation period (4 weeks after heart surgery) until the end of the 24th rehabilitation session
Method of measurement
The rate of hospital visits based on the admission data
3
Description
Mileage in the 6-minute test
Timepoint
The first rehabilitation session after cardiac surgery and the end of the 24th rehabilitation session
Method of measurement
Refer the patient to the rehabilitation clinic and perform a 6-minute test at the institute
4
Description
LVEF (%)
Timepoint
First postoperative echocardiography compared to echocardiography after the rehabilitation period
Method of measurement
Through echocardiography with Echo Philips device
5
Description
patient’s satisfaction at the end of the rehabilitation period (0-10)
Timepoint
After the rehabilitation period
Method of measurement
It is measured by a question from zero to ten
6
Description
quality of life
Timepoint
Before starting the rehabilitation program and after the 24th session of rehabilitation
Method of measurement
SF36 questioner
7
Description
spo2 rest& peak in 6MWD
Timepoint
Before the rehabilitation period at the rehabilitation clinic and after the end of the 24th rehabilitation session
Method of measurement
via 6MWT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Homebased group
Category
Rehabilitation
2
Description
Control group:Hospital Rehabilitation group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Institue
Full name of responsible person
Shiva Khaleghparast
Street address
Valiasr Ave, Niayesh Blvd, Rajaie Cardiovascular Medical and Research Institue
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3283
Fax
Email
khaleghparast.sh@rhc.ac.ir
Web page address
https://rhc.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular, Medical and Research Institue
Full name of responsible person
Saiedeh Mazloomzadeh
Street address
Valiasr Ave, Niayesh Blvd, Rajaie Cardiovascular, Medical and Research Institue
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3283
Email
khaleghparast.sh@rhc.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular, Medical and Research Institue
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
Rajaie Cardiovascular Medical and Research Institue
Full name of responsible person
Shiva Khaleghparast
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Ave, Niayesh Blvd, Rajaie Cardiovascular Medical and Research Institue
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2645
Email
khaleghparast.sh@rhc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Institue
Full name of responsible person
Shiva Khaleghparast
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Ave, Niayesh Blvd, Rajaie Cardiovascular Medical and Research Institue
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2645
Email
khaleghparast.sh@rhc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Institue
Full name of responsible person
Shiva Khaleghparast
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Ave, Niayesh Blvd, Rajaie Cardiovascular Medical and Research Institue
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2645
Email
khaleghparast.sh@rhc.ac.ir
Sharing plan
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 will be made available to others after de-identification
When the data will become available and for how long
data availability starts 6 months after final publishing of results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
All the data will be placed in the Mendeley software after publshing , and it will be possible to access this way.
From where data/document is obtainable
It will be accessible in the Mendeley software. Just search the title of the study
What processes are involved for a request to access data/document
After publishing, the data will be placed in the Mendeley software and other researchers can access this data by searching the title.