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The effect of cardiac and respiratory rehabilitation in the second phase of cardiac rehabilitation on the quality of life of patients undergoing coronary artery bypass graft surgery

Protocol summary

Study aim
Determination of the effect of pulmonary cardiac rehabilitation in the second phase of cardiac rehabilitation on the quality of life of patients undergoing coronary artery bypass graft surgery
Design
Clinical practice with control group, with parallel groups, randomized
Settings and conduct
Department of Cardiac Rehab in Imam Reza Hospital, Mashhad
Participants/Inclusion and exclusion criteria
Entry requirements: Age aged 65-18 years The first experience of coronary artery bypass graft surgery EF equal to or greater than 25% No major respiratory illness, such as asthma, bronchiectasis, and COPD No history of participation in the cardiac rehab program No smoking and tobacco at the moment Not a history of any vascular surgery Conditions of non-arrival: Cancellation of the continuation of the program Abandonment more than twice in the rehab program Stressful life events (deaths of first class relatives, financial bankruptcy, severe family)
Intervention groups
In the control group, 10 sessions of 1.5 hours were performed on routine in the cardiac rehabilitation program, which included treadmill, fixed bicycle and arm restraint, and in the intervention group after each intervention, the cardiac rehab program was performed for 20-30 minutes Under the lung rehab program, including deep breathing and effective cough, motivational spirometry, lung function, upper and lower extremity exercises and resistance exercises, as well as training for these exercises at home.
Main outcome variables
respiratory muscle strength, lung capacity, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190707044132N1
Registration date: 2019-10-27, 1398/08/05
Registration timing: registered_while_recruiting

Last update: 2019-10-27, 1398/08/05
Update count: 0
Registration date
2019-10-27, 1398/08/05
Registrant information
Name
Mahjobe Akar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3252 3972
Email address
akarm961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cardiac and respiratory rehabilitation in the second phase of cardiac rehabilitation on the quality of life of patients undergoing coronary artery bypass graft surgery
Public title
cardiac and respiratory rehabilitation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 65-18 years The first experience of coronary artery bypass graft surgery EF equal to or greater than 25% No major respiratory illness, such as asthma, bronchiectasis, and COPD No history of participation in the cardiac rehab program No smoking and tobacco now No history of any thoracic surgery Having the ability to communicate verbally Having reading and writing skills No known psychological disorder
Exclusion criteria:
Cancel to continue to participate Abandonment more than twice in the rehab program Occurrence of pleural effusion and cardiogenic pulmonary edema Life-threatening events (deaths of first class relatives, financial bankruptcy, severe family members' illness ) Prohibition of rehabilitation according to a cardiologist or rehab
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Time Blocking Randomization Tool: SPSS statistical software
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 Mashhad University Of Medical Sciences
Street address
Mashhad Nursing And Midwifery Schole, Ebne Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2019-05-18, 1398/02/28
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.015

Health conditions studied

1

Description of health condition studied
Pulmonary Rehab, Cardiac Rehab, Open Heart Surgery
ICD-10 code
I24
ICD-10 code description
Other acute ischemic heart diseases

Primary outcomes

1

Description
Quality of Life Score in Power and Ferrans Questionnaire
Timepoint
Measure the quality of life score at the beginning of the intervention and the session of ten interventions
Method of measurement
Power and Ferrans Quality of Life Score Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients undergo pulmonary rehabilitation for 20-30 minutes after each session of cardiac rehabilitation program, including deep breathing and effective coughing, motivational spirometry, pulmonary exercise, upper and lower extremity exercises, and resistance training.
Category
Other

2

Description
Control group: Patients attend a 10-hour 1.5-hour routine routine cardiac rehabilitation program that includes a treadmill, a stationary bike, and an ergometer arm.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Seyed Reza Mazlum
Street address
ebne sina st
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 11 3252 3972
Email
mazlomr@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Robabeh Latifnezhad
Street address
Ebne- Sina Street,School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3852 8511
Fax
+98 51 3852 8511
Email
mazlomr@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad university of medical science
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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Reza Mazlum
Position
Academic staff
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ebne sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 11 3252 3972
Email
mazlomr@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Reza Mazlom
Position
Academic Staff
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ebne Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 11 3252 3972
Email
mazlomr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mahjobe akar
Position
Student of Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
mashhad nursing and midwifery schole, ebne sina st
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 911 717 2598
Email
akarm961@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
For researchers working only in academic and scientific institutions
Under which criteria data/document could be used
Health Centers
From where data/document is obtainable
Mashhad School of Nursing and Midwifery
What processes are involved for a request to access data/document
Immediately by visiting the library of Mashhad School of Nursing and Midwifery
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