Effects of Prehabilitation Resistance Exercise in mild to moderate clinically frail patients for improving postoperative outcomes in Coronary Artery Bypass Grafting patients.
To evaluate effects of Prehabilitation Resistance Exercise in mild to moderate clinically frail patients for improving postoperative outcomes in Coronary Artery Bypass Grafting patients.
Design
Single Blinded Quasi Experimental Clinical Design
Settings and conduct
Faisalabad Institute of Cardiology,Faisalabad,Punjab,Pakistan setting used for research purpose.Patients will be allocated in groups according to Inclusion and exclusion Criteria.HHQ-GP 1 will be used as screening tool.Trails will be performed and results obtained from outcome variables will be noted at baseline,3rd week and Postoperative before discharge.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients between the ages of 40-65 years. Both male and female. Patients who are awaiting Coronary Artery Bypass Grafting. Pstients who are willing to participate in study will be included.Exclusion Criteria: Patients who are suffering from Chronic respiratory conditions like asthma,chronic obstructive pulmonary and intersitial lung disease. Patients with neurological disability.
Patients with endocrine abnormalities e.g; hypo and hyperthyroidism. Patients with concomitant valve disease,anemia,pacemaker reliance and obesity according to Body Mass Index will be excluded.
Intervention groups
Treatment will be provided for 2 times a day , 10-15 repetitions, five days and for three weeks to both groups. Resistance Training Group will perform resistance exercises of major mucle groups of upper and lower limbs which consists of Shoulder over head press, Biceps Curl, Knee lift and Hamstring Curls exercises . Conventional Group will perform Early Mobilization and Deep Breathing exercises which includes Diaphragmatic Breathing with pursing of lips .
Main outcome variables
Clinical Frailty Scale,Distance covered in 6 Minute Walk Test,Heart Rate and Oxygen Saturation.
General information
Reason for update
Acronym
CABG
IRCT registration information
IRCT registration number:IRCT20220704055364N2
Registration date:2023-02-18, 1401/11/29
Registration timing:prospective
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
Registrant information
Name
Umama Umar
Name of organization / entity
Faisal institute of health sciences faisalabad
Country
Pakistan
Phone
+92 317 7816746
Email address
umamaumar450@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-26, 1401/12/07
Expected recruitment end date
2023-05-25, 1402/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Prehabilitation Resistance Exercise in mild to moderate clinically frail patients for improving postoperative outcomes in Coronary Artery Bypass Grafting patients.
Public title
Effects of Prehabilitation Resistance Exercise in mild to moderate clinically frail patients for improving postoperative outcomes in Coronary Artery Bypass Grafting patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between the ages of 40-65 Years.
Patients who are awaiting Coronary artery bypass grafting.
Patients who are willing to participate in study.
Exclusion criteria:
Patients who are suffering from chronic respiratory conditions like asthma,chronic obstructive pulmonary disease and intersitial lung disease.
Patients suffering from chronic renal insufficiency.
Patients with endocrine abnormalities e.g hypo and hyperthyroidism.
Patients with concomitant valve disease,Anemia,pacemaker reliance and obesity according to Body Mass Index will be excluded .
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
More than 1 sample in each individual
Number of samples in each individual:
29
Patients will be non -randomly assigned each group each group will comprise of 29 patients.
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 Faisal institute of health sciences, faisalabad
Street address
673-A Lower Canal Road E, Block A peoples Colony no 1, Faisal Hospital, Faisalabad.
City
Faisalabad
Postal code
38000
Approval date
2023-01-25, 1401/11/05
Ethics committee reference number
FIHS/DPT/805
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Grafting (CABG) is a medical treatment to increase blood flow to the heart is often known as heart bypass surgery.
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass graft and biological heart valve graft
Primary outcomes
1
Description
The Clinical Frailty Scale (CFS) is a frailty instrument based on judgement that assesses key areas such as comorbidity, function, and cognition to produce a frailty score ranging from 1 (extremely fit) to 9 (terminally ill).
Timepoint
3time points including Baseline, After 3rd week and Postoperatively before discharge .
Method of measurement
CFS will be measured by Clinical Frailty Scale Questionnaire.
Secondary outcomes
1
Description
The six-minute walk test (6MWT) calculates a person's maximum walking distance over the course of six minutes on a level, firm surface.
Timepoint
3time points including Baseline, After 3rd week and Postoperatively before discharge
Method of measurement
6 Minute Walk Test will be measured by Distance Covered in 6 Minute Walk .
2
Description
Heart rate is define as the rate of heartbeat."The average heart rate is 72 beats per minute."
Timepoint
3time points including Baseline, After 3rd week and Postoperatively before discharge
Method of measurement
Heart Rate will be measured by pulse Oximetry.
3
Description
The oxygen saturation test determines how much oxygen is carried by your blood's haemoglobin. Humans' arterial blood oxygen saturation values are typically between 97 and 100 percent.
Timepoint
3time points including Baseline, After 3rd week and Postoperatively before discharge
Method of measurement
Pulse oximetry will be used to measured Oxygen Saturation.
4
Description
Ventilation Duration(hours) is the time from the patient entered the ICU to the time of extubation.
Timepoint
1 time postoperatively.
Method of measurement
Ventilation Duration will be measured in hours from the patient entered the ICU to the time of extubation.
5
Description
Postoperative Hospital Stay (Days) is the days patient stay in hospital after surgery.
Timepoint
1 time postoperatively
Method of measurement
Postoperative Hospital Stay (Days) will be measured by days patient stay in hospital after surgery.
Intervention groups
1
Description
Intervention group 1; Resistance Training Group will perform resistance exercises of major mucle groups of upper and lower limbs which consists of Shoulder over head press, Biceps Curl, Knee lift and Hamstring Curls exercises will be provided for 2 times a day , 10-15 repetitions, five days and for three weeks.
Category
Rehabilitation
2
Description
Control group 2; Conventional Group will perform Early Mobilization and Deep Breathing exercises which includes Diaphragmatic Breathing with pursing of lips will be provided for 2 times a day , 10-15 repetitions, five days and for three weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faisalabad Institute of Cardiology Faisalabad
Full name of responsible person
Dr Amir Mushtaq
Street address
Faisalabad Institute of Cardiology, Club-Road, Opposite Chenab Club Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9201529
Fax
+92 41 9201518
Email
ms.ic.fsd@punjab.gov.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faisal Institute of Health Sciences Faisalabad
Full name of responsible person
Dr Komal Tariq
Street address
673-A, Canal Road E, A Block Peoples colony, Faisal Hospital, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 331 7867850
Email
fihsfsd@outlook.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self Financed
Proportion provided by this source
100
Public or private sector
Private
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
Faisal Institute of Health Sciences Faisalabad
Full name of responsible person
Dr Umama Umar
Position
Principle Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
673-A,Canal Road E, A Block ,Peoples Colony no: 1, Faisal Hospital , Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
009241856999
Email
Umamaumar450@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faisal Institute of Health Sciences Faisalabad
Full name of responsible person
Dr Komal Tariq
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal Institute of Health Sciences Faisalabad Full name of responsible person Dr Komal Tariq Street address 673-A, Canal Road E, A Block Peoples colony, Faisal Hospital, Faisalabad Email fihsfsd@outlook.com
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8536999
Email
fihsfsd@outlook.com
Person responsible for updating data
Contact
Name of organization / entity
Faisal Institute of Health Sciences Faisalabad
Full name of responsible person
Dr Umama Umar
Position
Principle Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
673-A Canal Road E, A Block , Faisal Hospital Peoples Colony no 1 Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
009241856999
Email
Umamaumar450@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available