comparative effect of preoperative resistance and aerobic training in pre frail to moderately frail patients for improving quality of recovery in post coronary artery bypass grafting surgery patients
To determine the comparative effect of resistance and aerobic training in pre frail to moderately frail patients for improving quality of recovery in post coronary artery bypass grafting surgery patients
Design
Non Randomized, quasi experimental design of 46 patients were enrolled. Two arm parallel group with non blinded outcome assessment
Settings and conduct
The setting was Faisalabad Institute of Cardiology Faisalabad and the trial was quasi experimental study and factorial design was used.
Participants/Inclusion and exclusion criteria
The participants were selected on the basis of age 40 -65 years, both male and female were included, patient with double and triple vessel coronary artery disease were also included and patients who were mildly to moderately frail and had a Clinical Frailty Scale of 4-6 before surgery at the hospital setting and the participants were excluded on the basis of patient with unstable or recently unstable cardiac syndrome, prehabilitation is contraindicated in cases where a patient cannot follow study protocols due to cognitive impairment, patients who were severely frail (CSF 7-9) and a lack of consistency in attending prehabilitation treatments.
Intervention groups
Intervention group 1: After giving participants the baseline treatment. Group 1 recieved aerobic training including walking for 10-15 minutes and stepping 8-12 repetitions.
Intervention group 2: After giving participants the baseline treatment. Group 2 recieved resistance training including shoulder overhead press, biceps curl, hamstrings curl and knee lift 10-15 repetitions.
Main outcome variables
Clinical Frailty Scale
Quality of recovery
WHO Disability Assessment Score 2.0
General information
Reason for update
Acronym
CABG
IRCT registration information
IRCT registration number:IRCT20220902055851N1
Registration date:2022-10-17, 1401/07/25
Registration timing:retrospective
Last update:2022-10-17, 1401/07/25
Update count:0
Registration date
2022-10-17, 1401/07/25
Registrant information
Name
Dr Nimra Aftab
Name of organization / entity
GOVT COLLEGE UNIVERSITY FIASALABAD, PUNJAB, PAKISTAN
Country
Pakistan
Phone
+92 41 8536999
Email address
nimraaftab866@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-04, 1401/03/14
Expected recruitment end date
2022-09-28, 1401/07/06
Actual recruitment start date
2022-06-04, 1401/03/14
Actual recruitment end date
2022-08-28, 1401/06/06
Trial completion date
2022-09-04, 1401/06/13
Scientific title
comparative effect of preoperative resistance and aerobic training in pre frail to moderately frail patients for improving quality of recovery in post coronary artery bypass grafting surgery patients
Public title
comparative effect of preoperative resistance and aerobic training in pre frail to moderately frail patients for improving quality of recovery in post coronary artery bypass grafting surgery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 4o -65 years
Both male and female
Patient with double and triple vessel coronary artery disease
Patients who were mildly to moderately frail and had a Clinical Frailty Scale of 4-6 before surgery at the hospital setting
Exclusion criteria:
Patient with unstable or recently unstable cardiac syndrome
Prehabilitation is contraindicated in cases where a patient cannot follow study protocols due to cognitive impairment
Patients who are severely frail (CSF 7-9)
A lack of consistency in attending prehabilitation treatments
Age
From 45 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
55
Actual sample size reached:
46
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 committe of Government College University Faisalabad
3 timepoints including Baseline, preoperative 3rd week after treatment and postoperative before discharge.
Method of measurement
15- item Quality of recovery was utilized to assess pain
Secondary outcomes
1
Description
The secondary outcome was frailty.
Timepoint
3 timepoints including Baseline, preoperative 3rd week after treatment and postoperative before discharge
Method of measurement
Clinical Frailty Scale was used to assess frailty. The CFS scale consist of 9 points, which range from non-frail that scores 1–3, vulnerable/pre-frail that has scoring of 4 and frailty scores from 5–9.
2
Description
Another secondary outcome was disability free survival.
Timepoint
2 timepoints including baseline and postoperative one month after discharge
Method of measurement
WHO Disability Assessment Schedule 2.o score was used to monitor changes in disability free survival. Disability scores ranges from 0-4%, 5-24%, 25-49%, 50-95%, 96-100% for none, mild moderate, severe and complete disability respectively.
Intervention groups
1
Description
Intervention group 1: After giving participants the baseline treatment. Group A recieved aerobic training included walking for 10-15 minutes and stepping 8-12 repetitions.
Category
Rehabilitation
2
Description
Intervention group 2: After giving participants the baseline treatment. Group B recieved resistance training included shoulder overhead press, biceps curls, hamstrings curls and knee lift one set of 10-15 repetitions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faisalabad Institute of Cardiology
Full name of responsible person
Dr. Amir Mushtaq
Street address
New Chenab Club, sargodha Rd, Civil Lines, Faisalabad, Punjab.
City
Faisalabad
Postal code
38000
Phone
+92 41 9201529
Email
ms.ic.fsd@punjab.gov.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faisal Institute Of Health Sciences
Full name of responsible person
Dr. Ramisha Tahir
Street address
673-A Lower Canal Rd E, Block A People's Colony No 1, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8536999
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Faisal Institute Of Health Sciences
Full name of responsible person
Dr. Komal Tariq; PT
Position
Principle Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
C483+95F, Block A People's Colony No 1, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8536999
Email
fihsfsd@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faisal Institute Of Health Sciences
Full name of responsible person
Dr. Komal Tariq; PT
Position
Principle Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
C483+95F, Block A People's Colony No 1, Faisalabad, Punjab
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
Full name of responsible person
Dr. Komal Tariq; PT
Position
Principle Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
C483+95F, Block A People's Colony No. 1, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8536999
Email
fihsfsd@outlook.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