Assessing the effect of preoperative rehabilitation (prehab) program on physical function, balance and fear of fall of patients candidate for coronary artery bypass graft surgery
Determining the effect of preoperative rehabilitation program on physical function, balance and fear of falling in patients candidates for coronary artery bypass grafting (CABG)
Design
A clinical trial with a control group, with parallel groups without blinding, randomized on 92 patients, used the rand function of Excel software for randomization.
Settings and conduct
Research population: Elective heart surgery patients who refer to selected hospitals of Tehran University of Medical Sciences (Imam Khomeini Hospital and Tehran Heart Center). Otago exercise, leg exercise and breathing exercises in the first session in person for 45-60 minutes
Provide videos and educational booklets to patients
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
Adult patients at home (age over 60 years)
On the waiting list for heart surgery for four weeks or more
Heart surgery for the first time
Ability to speak Persian
Ability to use mobile and social networks
Hemodynamically stable
Willingness to participate in the study
Inclusion criteria include cases of rehabilitation contraindications, such as cognitive impairment
Inability to perform study steps
Physical limitations prevent rehabilitation such as severely impaired patients.
Intervention groups
Preoperative rehabilitation program includes Otago exercise, stimulus spirometry use, coughing, and walking.
Otago training protocol for four weeks, three sessions per week and the duration of each training session is 20 minutes
Telephone interviews twice a week with patients to evaluate performance
Upon completion of the study, postoperative care will be provided to members of the control group in order to comply with the Otago sports ethics and training manual.
Main outcome variables
preoperative rehabilitation program
Physical function, balance and fear of falling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220523054974N1
Registration date:2022-06-17, 1401/03/27
Registration timing:prospective
Last update:2022-06-17, 1401/03/27
Update count:0
Registration date
2022-06-17, 1401/03/27
Registrant information
Name
Zoleikha Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7644 3892
Email address
abbasi-z@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of preoperative rehabilitation (prehab) program on physical function, balance and fear of fall of patients candidate for coronary artery bypass graft surgery
Public title
Assessing the effect of preoperative rehabilitation (prehab) program on physical function, balance and fear of fall of patients candidate for coronary artery bypass graft surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients at home (over the age of 60, according to the World Health Organization) waiting for coronary artery bypass graft surgery.
Be on the waiting list for heart surgery for four weeks or more.
Patients undergoing heart surgery for the first time.
Be able to speak Persian and be literate.
Be able to use mobile phones and social networks.
Patients who are hemodynamically stable
And tend to participate in the study.
Exclusion criteria:
Inclusion criteria include cases of rehabilitation contraindications, such as those with cognitive impairment and inability to complete the study process.
Physical limitations that prevent rehabilitation, such as patients who are severely debilitated.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Since the participants in this study gradually enter the study and in order not to create a balance in the number of participants in the two intervention and control groups, we will use random block allocation with square blocks. Using Excel 23 software, four blocks are defined, which in each block of houses are randomly divided between the control and intervention groups. Then, based on the order of the houses, the preparation cards are determined, which is the order of the 92 cards, which represent the group of each participant. Then each card is completely covered using a paper cover and the cards are coded in the previously specified order. With each person entering, an uncoated card is assigned and the assigned group of each person is completely random and in full compliance. Blindness is responsible for random allocation.
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 School of Nursing and Midwifery and School of Rehabilitation, Tehran University
Street address
Nosrat st., Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-05-21, 1401/02/31
Ethics committee reference number
IR.TUMS.FNM.REC.1401.021
Health conditions studied
1
Description of health condition studied
Patients undergoing coronary artery bypass graft surgery
ICD-10 code
I51.9
ICD-10 code description
Heart disease, unspecified
Primary outcomes
1
Description
Physical function, balance
Timepoint
12 months
Method of measurement
Patients' physical function (sppb), balance (berg), fear of falling (fes1) will be measured using designated instruments. The Short-Term Physical Function Assessment Questionnaire (SPPB) is a test designed to assess a patient's physical function. Balance in this study is based on the Leaf Balance Test (BBS), which is used to measure the balance of the elderly.
Secondary outcomes
1
Description
Fear of falling
Timepoint
12 months
Method of measurement
International Fall Efficiency Scale Form: FES-1: This form has 10 items and the items in this questionnaire have four options (I am completely worried so I am not worried at all) (grades one to four) and each subject scores a total of 16 questions. Is (between 16 and 64); Each question measures the level of anxiety about falling when performing each of these activities on a 4-point scale (grades 1 to 4) and has 4 options (I am not worried about falling at all) to (I am completely worried about falling). Scores range from 16 to 64, with scores of 19-19 being the least worrying, scores of 20-27 being the average concern, and scores of 28-64 being the most worrying, with a higher score or score indicating concern or fear. more than
Intervention groups
1
Description
Intervention group: The members of the intervention group include people who will be randomly assigned to the intervention group based on the inclusion criteria. Consent to participate in the study will be taken from the group members. The use of the designated instrument in the form of practical tests based on performance will be completed by the researcher. The equipment required for these tests is a stopwatch, a chair and a meter. Then, preoperative rehabilitation program in the present study includes otago exercise, use of spirometer, cough and walking. Minutes will be taught. Intervention team members will be asked to practice the Otago Training Protocol for four weeks, three sessions per week, and each session lasts 20 minutes at home. The start of the Otago exercise program will include head movements, neck movements, torso extensions, torso movements and ankle movements, as well as balance exercises including bending the knee while standing, walking backwards, walking on heels and toes, standing on one foot. Changing posture from sitting to standing and walking up the stairs will also be included in the exercise program. Respiratory rehabilitation will also include diaphragmatic breathing and chest relaxation (10 attempts at deep breathing, deep nasal inhalation and exhalation), postural training (training in protective positions and cough movement, and use of respiratory spirometry with the patient. To provide the patient with self-care and correction of risk factors, nutritional care with the aim of providing energy to enable aerobic exercise, facilitate muscle repair and to adapt and help cope with metabolic stress surgery and psychological interventions to reduce anxiety and emotional burden. Patients will be taught about surgery, a comprehensive training program will be provided to patients in the form of a booklet and a training video, and subsequent sessions include telephone interviews with patients twice a week to assess their performance in exercise, breathing, nutrition and correction of risk factors. , Talk of new concerns and clarify and correct any misconceptions about heart surgery.If you need to retrain the exercises, the necessary explanations will be given and finally after four weeks of intervention and ensure complete and correct performance Intervention the day before surgery for the second time and the fourth week After the surgery, for the third time, the study variables of physical function, balance and fear of falling will be measured and recorded based on the patient's performance using tools and practical tests.
Category
Behavior
2
Description
Control group: Includes people who will be randomly assigned to the control group based on inclusion criteria. Consent to participate in the study will be taken from the group members Demographic characteristics questionnaire and physical function questionnaire, balance and fear of falling using the tools determined as a test The practice-based practice will be completed by the researcher and the group members will be explained that no intervention will be performed on these patients but will be monitored during the study and if necessary ambiguities and questions will be answered and one month later From heart surgery, when they go to visit their surgeon, the researcher will complete the questionnaires of physical function, balance and fear of falling again using the designated tools as practical tests based on performance. After completing the study, in order to observe exercise ethics Otago and the postoperative care training booklet will be provided to members of the group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Zoleikha Abbasi
Street address
North Kargar St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
zoleikhaabbasi@gmail.com
Web page address
https://thc.tums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Zoleikha Abbasi
Street address
Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2838
Email
Imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zoleikha Abbasi
Position
Master student of intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nosrat st., Tohid sq.
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 7644 3892
Email
zoleikhaabbasi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Elham Navab
Position
Associate Professor, School of Nursing & Midwifery, Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4412
Email
e-navab@sina.tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zoleikha Abbasi
Position
Master student of nursing intensive care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nosrat st., Tohid sq.
City
Tehran
Province
Tehran
Postal code
3981679111
Phone
+98 21 7644 3892
Email
zoleikhaabbsi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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