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Comparison of the impacts of progressive early physical rehabilitation & early comprehensive rehabilitation on illness outcome including fatigue, functional independence, anxiety, depression, medication adherence & quality of life in patients undergoing coronary artery bypass graft surgery (CABG): A randomized clinical trial

Protocol summary

Study aim
Comparison of the impacts of progressive early physical rehabilitation & early comprehensive rehabilitation on patients' outcomes in patients undergoing coronary artery bypass graft surgery
Design
This study is a single-blinded randomized clinical trial with a parallel three-arm design. Eligible samples will be randomly assigned to a control group and two intervention groups in a 1:1:1 ratio. Random allocation sequences will be generated using RAS by a non-research person, with random blocking using 3 and 6 blocks for allocation in the three groups.
Settings and conduct
The study will be conducted in the ICU ward of Shahid Madani Hospital in Tabriz on patients undergoing CABG surgery. Blinding in this study will be carried out using sealed opaque envelopes, and sequential numbering from one to the end will be used. The statistical analyst and outcome assessor will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Four-score more than 16; Age older than 18; ; Stable hemodynamics; No musculoskeletal issues; No amputations, No sensory& cognitive problems, cerebral vascular accidents, brain injury, radiotherapy, or chemotherapy. Exclusion criteria : History of arrest, activity-induced syncope, mechanical ventilation over 24 hours, tachycardia, bradycardia, ventricular dysrhythmias, opened sternum
Intervention groups
research involves 3 groups: 2 intervention groups and 1 control group. The control group receives routine rehabilitation, while the first intervention group undergoes comprehensive rehabilitation (physical, mental, and educational )for thirty days after discharge. The second intervention group focuses solely on physical rehabilitation for the same duration.
Main outcome variables
Fatigue; functional independence; depression; anxiety;medication adherence ; quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160110025937N8
Registration date: 2024-04-19, 1403/01/31
Registration timing: registered_while_recruiting

Last update: 2024-04-19, 1403/01/31
Update count: 0
Registration date
2024-04-19, 1403/01/31
Registrant information
Name
Aefeh Allahbakhshian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
allahbakhshiana@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-04, 1403/01/16
Expected recruitment end date
2024-09-06, 1403/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the impacts of progressive early physical rehabilitation & early comprehensive rehabilitation on illness outcome including fatigue, functional independence, anxiety, depression, medication adherence & quality of life in patients undergoing coronary artery bypass graft surgery (CABG): A randomized clinical trial
Public title
Comparison of the impacts of early physical rehabilitation & early comprehensive rehabilitation on patients' outcomes in patients undergoing coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ّFour Score scale equal to 16 patients who are candidates for non-emergency coronary artery bypass surgery over 18 years old patients with the ability to speak Farsi or Turkish stable hemodynamic status without taking cardiac inotropic drugs
Exclusion criteria:
Cardiac and respiratory arrest during surgery and after admission to the ward Syncope caused by activity and exercise Duration under mechanical ventilation for more than 24 hours Heart rate above 100 or having ventricular dysrhythmias Open sternum SpO2 below 90 Inability to establish correlation New ischemic changes in ECG Tachypnea Neuromusculoskeletal problems Unstable fractures limb amputation Hearing, vision and cognitive problems History of cerebrovascular accidents or traumatic brain injury Radiotherapy or chemotherapy in the last 6 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible available samples will be randomly assigned to the control group, The First Intervention group, and the Second Intervention group by assigning a 1: 1: 1 ratio. Random Allocation Sequences will be generated by the non-research person using RAS (Random Allocation Software) Software and Random Blocking will be generated using blocks of size 3 and 6 for Allocation in three groups (two intervention groups and one control group). The allocation concealment will be done based on the generated sequence using opaque, closed and uniform envelopes numbered from number 1 to the end. The first person to enter the study will be given envelope number 1 and this process will continue until the end.
Blinding (investigator's opinion)
Single blinded
Blinding description
Allocation concealment will be done based on the generated sequence using opaque, sealed envelopes numbered from 1 to the last. The first person who enters the study will be given envelope number 1 and this process will continue until the end. Therefore, the researcher and the research subject will not have any information about the type of allocation received until after the envelopes are opened. In this study, the statistical analyst and outcome reviewer will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
3rd floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.TBZMED.REC.1402.892

Health conditions studied

1

Description of health condition studied
Chronic ischemic heart disease
ICD-10 code
I25.82
ICD-10 code description
Chronic total occlusion of coronary artery

Primary outcomes

1

Description
functional independence
Timepoint
Before intervention , at discharge, a month after discharge
Method of measurement
modified barthel scale

2

Description
Quality of life
Timepoint
Before intervention , at discharge, a month after discharge
Method of measurement
SF-12 scale

3

Description
Fatigue
Timepoint
Before intervention , at discharge, a month after discharge
Method of measurement
MFI scale

4

Description
Anxiety and depression
Timepoint
Before intervention , at discharge, a month after discharge
Method of measurement
HADS scale

5

Description
Medical adherence
Timepoint
Before intervention , at discharge, a month after discharge
Method of measurement
MARS scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: common rehabilitation in cardiac wards
Category
Rehabilitation

2

Description
Intervention group 1: A comprehensive rehabilitation intervention will be used, conducted by the comprehensive rehabilitation team, including a heart surgeon, an anesthesiologist, and a researcher. Rehabilitation will begin one day before the surgical operation during the patient's hospitalization and will continue up to 30 days after discharge through weekly follow-up phone calls. It includes 4 components: physical rehabilitation, educational support, and relaxation. Physical rehabilitation includes exercises during hospitalization, such as breathing exercises, spirometry, walking, neck exercises, and post-discharge exercises, including walking at home and strengthening exercises for leg muscles (sitting and standing). Hospital-based exercises start 24 hours after the surgical operation and continue until discharge. They include 7-10 deep breathing exercises, spirometry exercises 4 times a day for 3-5 minutes until transfer from the intensive care unit to the surgical ward, and walking exercises until discharge from the hospital. Neck exercises consist of 10 repetitions, twice a day until discharge from the hospital. Post-discharge physical exercises include walking exercises for 30 days in 5-day episodes. Additionally, leg muscle strengthening exercises, including sitting and standing exercises, are performed at home in 2 episodes per day, each consisting of 10 repetitions. This educational component includes 3 sessions from pre-surgery to discharge, covering the nature of the disease, disease risk factors and exacerbating factors, medical and surgical treatments, familiarity with prescribed medications, awareness of the procedure type and its side effects, common complaints, treatment goals, attitude adjustment and expectations, familiarity with the intensive care unit environment, education on the importance of healthy behaviors, healthy and appropriate nutrition, physical exercises, blood pressure control, underlying diseases, personal risk factors, understanding signs of cardiac and vascular insufficiency, motivation to eliminate personal risk factors, and instilling the ability to control the disease and improve quality of life. Solutions to avoid stressful environments, including emotional control methods, emotional management counseling, and encouragement to participate in cardiac rehabilitation programs, are also provided. All the education provided and home care and rehabilitation instructions, including daily walking according to the protocol and the booklet provided to the patient in the first session, will be carried out. Relaxation techniques include 1 instructional session with the patient and performing techniques from the third day after the operation or admission to the surgical ward until 30 days after discharge, under hospital supervision and through follow-up phone calls. This includes teaching rhythmic breathing, then asking the intervention group patients to perform rhythmic breathing for 20 minutes, once every 5 minutes, and each time for 1 minute, as instructed. During the intervention, patients will not receive any supplemental oxygen. Additionally, progressive muscle relaxation is performed in the same relaxation session. The patient will perform this technique 4 times a day for 20 minutes and will be encouraged by the researcher to continue these techniques until discharge and at home, at least twice a day, with 2 repetitions each time.
Category
Rehabilitation

3

Description
Group 2 Intervention: For the second group, a physical rehabilitation intervention will be used, conducted by the comprehensive rehabilitation team, including a heart surgeon, an anesthesiologist, and a researcher. Rehabilitation will begin one day before the surgical operation during the patient's hospitalization and will continue up to 30 days after discharge through weekly follow-up phone calls. It includes 4 components: physical rehabilitation, educational support, and relaxation. Physical rehabilitation includes exercises during hospitalization, such as breathing exercises, spirometry, walking, neck exercises, and post-discharge exercises, including walking at home and strengthening exercises for leg muscles (sitting and standing). Hospital-based exercises start 24 hours after the surgical operation and continue until discharge. They include 7-10 deep breathing exercises, spirometry exercises 4 times a day for 3-5 minutes until transfer from the intensive care unit to the surgical ward, and walking exercises until discharge from the hospital. Neck exercises consist of 10 repetitions, twice a day until discharge from the hospital. Post-discharge physical exercises include walking exercises for 30 days in 5-day episodes. Additionally, leg muscle strengthening exercises, including sitting and standing exercises, are performed at home in 2 episodes per day, each consisting of 10 repetitions.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Atefe Allahbakhshian
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
allahbakhshiana@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Aefeh Allahbakhshian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
allahbakhshiana@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aefeh Allahbakhshian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
Associate professor
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
allahbakhshiana@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aefeh Allahbakhshian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
516566593198
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
allahbakhshiana@tbzmed.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
The information requested by the researchers for statistical analysis of the submitted proposal (meta-analysis) will be provided to them
When the data will become available and for how long
Starting access immediately after publication
To whom data/document is available
Data will be available to researchers as well as to journals
Under which criteria data/document could be used
The data will be available to researchers upon request and submission of a meta-analysis proposal using IPD data after individuals have been identified. It will also be made available to journals exclusively for exceptional data checking.
From where data/document is obtainable
Refer to allahbakhshiana@tbzmed.ac.ir
What processes are involved for a request to access data/document
Requests will be emailed and data will be available within a week.
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