Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000932561
Ethics application status
Approved
Date submitted
25/05/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of an early supervised exercise program in patients undergoing elective cardiothoracic surgery,
Scientific title
The Efficacy Of Graduated Exercise-Based Prehabilitation Program In Improving Cardiorespiratiry Fitness(GEtFit) For People Schedule For Cardiothoracic Surgery- A RCT
Secondary ID [1] 312167 0
nil known
Universal Trial Number (UTN)
Nil
Trial acronym
GEtFit Trial
Linked study record
Not Appropriate

Health condition
Health condition(s) or problem(s) studied:
Cardiothoracic surgery 333818 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330488 330488 0 0
Physiotherapy
Cardiovascular 330928 330928 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Exercise Progression Protocol Patients will be routinely referred to a Pre habilitation program. This will be a supervised groups of 4-6 participants at the outpatient hospital setting by a single Physiotherapist (more than 10 years clinical experiences in cardiac rehabilitation). Participants will engage in a graduated aerobic and strengthening exercise program prior to the date of their surgery. For the progressive resistance exercise, the following muscle groups will be targeted: biceps brachii, triceps brachii, pectoralis major and minor, latissimus dorsi, deltoid and rhomboids using free weights. Example of strength is the PVC weighted bar of 0.5 will be used as baseline and progressively increase until 8 weeks postoperatively at an intensity of 70-80% of estimated 10 repetitions maximum to accelerate recovery. The loads will be increased when the patients could manage 12 repetitions for both set on 2 consecutive training sessions, provided no sternal or joint pain or severe muscle fatigue and/or arm fatigue on RPE score of 10-13 on 6-20 of Rating Perceived Exertion Scale (RPE). In our study, in addition to the PVC weighted bar, we also used different types of resistance training such as band, dumbells, kettlebells. For aerobic exercise this will be a low intensity in week one with graduation to moderate intensity in week 2 on 6-20 of Rating Perceived Exertion Scale (RPE) of 10-13) of cardiovascular aerobic exercise training (Treadmill, Cycle ergometer) and education for secondary prevention 1-3 times per week (60 minutes) for overall duration typical 4(+/- 1 week) prior to date of surgery. In addition, participants will be given an illustrated handout to assist further training support by the carer (advice regarding maintaining a set amount of aerobic/strength exercise per week standard including sternal precautions based on Keep Your Move in the Tube'' (MinT) principles in the acute setting. The MinT conceptual framework using simple graphics depicting movements “in a green tube” and “out of a red tube”. Detailed session attendance checklist will be recorded weekly for adherence monitoring.
Intervention code [1] 328610 0
Rehabilitation
Comparator / control treatment
No prehabilitation was offered at the HCTM prior to this study. Participants in the standard care group (SG) will receive treatment as early supervised incremental resistance training (ESpIRiT) trial intervention protocol published previously (Md Ali et al, 2023). Specifically including education on standard sternal precautions based on Keep Your Move in the Tube'' (MinT) principles, dietary advice, advice regarding maintaining a set amount of strehgth/aerobic exercise per week, etc with the addition of the early supervised incremental upper limb resistance exercise with moderate to high intensity exercise of upper limb from the first week post-operatively in the acute setting. The standard treatment will be delivered in both verbal and written formats by the treating physiotherapists, and recommended for the first six weeks postoperatively. Physiotherapy care will commence pre-operatively in the form of education. Patients will be routinely assessed and screened for risk of post-operative pulmonary complications. Following extubation progressive mobilization (i.e. walking); active upper limb, foot and ankle exercise will commence. Prior to discharge the physiotherapist will educate the patient in continuing movement in the tube sternal precautions and a progressive program of mobilization. Patients will be routinely referred to a cardiac rehabilitation program in the outpatient hospital setting and will be able to commence this program 4-8 weeks following surgery pending availability. Cardiac rehabilitation (phase 2) will predominantly consist of low intensity (on 6-20 of Rating Perceived Exertion Scale (RPE) of 10-13) cardiovascular aerobic exercise training and education for secondary prevention 1-3 times per week (60 minutes) for a typical duration 6-12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 338257 0
cardiorespiratory fitness
Timepoint [1] 338257 0
Baseline (4 weeks ± 1 weeks prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months (primary timepoint) post-discharge,
Primary outcome [2] 338258 0
Respiratory muscle strength via Maximal Inspiratory Pressure (MIP)
Timepoint [2] 338258 0
Baseline (4 weeks ± 1 weeks prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months (primary timepoint) post-discharge.
Secondary outcome [1] 435180 0
Upper Limbs endurance
Timepoint [1] 435180 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
Secondary outcome [2] 435181 0
upper limbs function and thoracic region
Timepoint [2] 435181 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
Secondary outcome [3] 435182 0
Pain
Timepoint [3] 435182 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
Secondary outcome [4] 435183 0
Recovery using PostopQRS
Timepoint [4] 435183 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
Secondary outcome [5] 435184 0
Anxiety
Timepoint [5] 435184 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
Secondary outcome [6] 435189 0
Lung Function Testing
Timepoint [6] 435189 0
Pre-op (3 days prior to surgery) and 4 weeks post after discharge
Secondary outcome [7] 435190 0
Physical function
Timepoint [7] 435190 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
Secondary outcome [8] 435191 0
Functional assessment
Timepoint [8] 435191 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
Secondary outcome [9] 435192 0
sternum stability
Timepoint [9] 435192 0
at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
Secondary outcome [10] 435193 0
self-reported measure of patients’ perceived change
Timepoint [10] 435193 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
Secondary outcome [11] 435194 0
Health-related QoL
Timepoint [11] 435194 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
Secondary outcome [12] 435195 0
handgrip strength (kg)
Timepoint [12] 435195 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months
Secondary outcome [13] 437053 0
Mobility tasks (supine to sitting on the edge of the bed, sit to stand, walking, and negotiation of one step),
Timepoint [13] 437053 0
7 day post-operatively
Secondary outcome [14] 437054 0
Physical capacity
Timepoint [14] 437054 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
Secondary outcome [15] 437055 0
Health Related Quality of Life
Timepoint [15] 437055 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
Secondary outcome [16] 438129 0
Depression
Timepoint [16] 438129 0
Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.

Eligibility
Key inclusion criteria
1.Scheduled for elective cardiothoracic surgery at least 4 weeks after enrolment into study;
2.Able to provide informed consent; and
3 Adults over the age of 18
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Emergency operation
• medically unstable
• Impaired vision, cognition, confusion or physical impairment (UL and LL) in functional task components

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After recruitment and baseline testing, participants will be randomised post-operatively by an independent person using a computer-generated random number sequence which, will allocate each participant to one of two groups that include standard care or intervention group via block randomization table (7 block of 70) via sealed opaques envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation 1 to 78
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat analaysis. Changes in outcome variables over time will be analysed with repeated measures analysis of variance (ANOVA) or non-parametric equivalent (Kruskall Wallis) comparing different assessment time points. For all tests p<0.05 will be considered statistically significant and confidence interval will be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment outside Australia
Country [1] 26311 0
Malaysia
State/province [1] 26311 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 316533 0
Hospital
Name [1] 316533 0
Hospital Canselor Tuanku Muhriz
Country [1] 316533 0
Malaysia
Primary sponsor type
University
Name
Univeristy Kebangsaan Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 318713 0
None
Name [1] 318713 0
Address [1] 318713 0
Country [1] 318713 0
Other collaborator category [1] 283038 0
Individual
Name [1] 283038 0
Prof. Alistair Royse - Royal Melbourne Hospital, Australia
Address [1] 283038 0
Country [1] 283038 0
Australia
Other collaborator category [2] 283039 0
Individual
Name [2] 283039 0
Prof Doa El-Ansary - RMIT University, Melbourne Australia
Address [2] 283039 0
Country [2] 283039 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315326 0
Research Ethics Commitee, National University of Malaysia
Ethics committee address [1] 315326 0
Sekretariat Etika Penyelidikan UKM Tingkat 1, Blok Klinikal, Pusat Perubatan UKM Jalan Yaakob Latiff, Bandar Tun Razak 56000 Cheras, Kuala Lumpur.
Ethics committee country [1] 315326 0
Malaysia
Date submitted for ethics approval [1] 315326 0
28/12/2023
Approval date [1] 315326 0
25/03/2024
Ethics approval number [1] 315326 0
JEP-2023-994

Summary
Brief summary
This is randomized controlled trial in Malaysia is to investigate whether the effects of graduated exercise-based prehabilitation program compared to standard care will impact on cardiorespiratory fitness, respiratory muscle strength, upper limbs function, pain, functional capacity, multi-domain recovery, psychological recovery, recovery of physical function and QOL for people awaiting Cardiothoracic surgery
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134346 0
A/Prof Nur Ayub Md Ali
Address 134346 0
Heart and Lung Centre, Hospital Canselor Tuanku Muhkriz, Jalan Yaacob Latif Kuala lumpur, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia'.
Country 134346 0
Malaysia
Phone 134346 0
+60391454866
Fax 134346 0
Email 134346 0
[email protected]
Contact person for public queries
Name 134347 0
Katijjahbe Md Ali
Address 134347 0
Heart and Lung Centre, Hospital Canselor Tuanku Muhkriz, Jalan Yaacob Latif Kuala lumpur, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia'.
Country 134347 0
Malaysia
Phone 134347 0
+60391454866
Fax 134347 0
Email 134347 0
[email protected]
Contact person for scientific queries
Name 134348 0
Katijjahbe Md Ali
Address 134348 0
Heart and Lung Centre, Hospital Canselor Tuanku Muhkriz, Jalan Yaacob Latif Kuala lumpur, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia'.
Country 134348 0
Malaysia
Phone 134348 0
+60391454866
Fax 134348 0
Email 134348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participants number 1 to 78
Intervention grouping
individual outcome data
When will data be available (start and end dates)?
Completion of trials when published December 2027 (start date 1/8/2024 - end date i.e Immediately following publication (estimated December 2027) and data will be available for 5 years after publication. Data will be provided as supplementary appendix during publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For IPD meta-analyses,
How or where can data be obtained?
Completion of trials when published. Data will be provided as supplementary appendix


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.