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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,
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Scientific title
The Efficacy Of Graduated Exercise-Based Prehabilitation Program In Improving Cardiorespiratiry Fitness(GEtFit) For People Schedule For Cardiothoracic Surgery- A RCT
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Secondary ID [1]
312167
0
nil known
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Universal Trial Number (UTN)
Nil
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Trial acronym
GEtFit Trial
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Linked study record
Not Appropriate
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Health condition
Health condition(s) or problem(s) studied:
Cardiothoracic surgery
333818
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Condition category
Condition code
Physical Medicine / Rehabilitation
330488
330488
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0
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Physiotherapy
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Cardiovascular
330928
330928
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328610
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Rehabilitation
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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cardiorespiratory fitness
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Assessment method [1]
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The 6-Min Walk Test
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Timepoint [1]
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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,
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Primary outcome [2]
338258
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Respiratory muscle strength via Maximal Inspiratory Pressure (MIP)
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Assessment method [2]
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Maximal Inspiratory Pressure (MIP) with a respiratory pressure meter,
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Timepoint [2]
338258
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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.
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Secondary outcome [1]
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Upper Limbs endurance
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Assessment method [1]
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The Unsupported Upper Limb Exercise Test (UULEX)
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Timepoint [1]
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
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Secondary outcome [2]
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upper limbs function and thoracic region
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Assessment method [2]
435181
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The Functional Difficulty Questionnaire Shortened Version
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Timepoint [2]
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
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Secondary outcome [3]
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Pain
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Assessment method [3]
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The Numerical Rating Scale For Pain
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Timepoint [3]
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
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Secondary outcome [4]
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Recovery using PostopQRS
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Assessment method [4]
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PostopQRS
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Timepoint [4]
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
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Secondary outcome [5]
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Anxiety
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Assessment method [5]
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Hospital Anxiety and Depression Scale
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Timepoint [5]
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
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Secondary outcome [6]
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Lung Function Testing
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Assessment method [6]
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Forced vital capacity (FVC), forced expiratory volume exhaled at the first second (FEV1) and FEV1/FVC ratio can be obtained from spirometry test
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Timepoint [6]
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Pre-op (3 days prior to surgery) and 4 weeks post after discharge
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Secondary outcome [7]
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Physical function
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Assessment method [7]
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Short Physical Performance Battery (SPPB)
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Timepoint [7]
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
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Secondary outcome [8]
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Functional assessment
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Assessment method [8]
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1 minute Sit to Stand
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Timepoint [8]
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
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Secondary outcome [9]
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sternum stability
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Assessment method [9]
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Sternal Instability Scale (SIS)
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Timepoint [9]
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at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
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Secondary outcome [10]
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self-reported measure of patients’ perceived change
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Assessment method [10]
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The Global Rating of Change Scale (7 point)
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Timepoint [10]
435193
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge,
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Secondary outcome [11]
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Health-related QoL
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Assessment method [11]
435194
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EQ-5D-5L
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Timepoint [11]
435194
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
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Secondary outcome [12]
435195
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handgrip strength (kg)
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Assessment method [12]
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handheld dynamometer.
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Timepoint [12]
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months
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Secondary outcome [13]
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Mobility tasks (supine to sitting on the edge of the bed, sit to stand, walking, and negotiation of one step),
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Assessment method [13]
437053
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Rate of change of the Modified Iowa Level of Assistance.
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Timepoint [13]
437053
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7 day post-operatively
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Secondary outcome [14]
437054
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Physical capacity
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Assessment method [14]
437054
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Self-Assessment of Physical Activity Questionnaire (SAQ).
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Timepoint [14]
437054
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
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Secondary outcome [15]
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Health Related Quality of Life
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Assessment method [15]
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the SF-36 Health Questionnaire shorthened version
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Timepoint [15]
437055
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
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Secondary outcome [16]
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Depression
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Assessment method [16]
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Hospital Anxiety and Depression Scale
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Timepoint [16]
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Baseline (4 weeks ± 1 weeks) prior to date of surgery), at time of discharge, 4 weeks, 3 months and 6 months post-discharge.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Emergency operation
• medically unstable
• Impaired vision, cognition, confusion or physical impairment (UL and LL) in functional task components
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation 1 to 78
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
31/12/2026
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
78
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26311
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Malaysia
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State/province [1]
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Kuala Lumpur
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Funding & Sponsors
Funding source category [1]
316533
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Hospital
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Name [1]
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Hospital Canselor Tuanku Muhriz
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Address [1]
316533
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Country [1]
316533
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Malaysia
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Primary sponsor type
University
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Name
Univeristy Kebangsaan Malaysia
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Address
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Country
Malaysia
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Secondary sponsor category [1]
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None
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Name [1]
318713
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Address [1]
318713
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Country [1]
318713
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Other collaborator category [1]
283038
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Individual
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Name [1]
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Prof. Alistair Royse - Royal Melbourne Hospital, Australia
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Address [1]
283038
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Country [1]
283038
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Australia
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Other collaborator category [2]
283039
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Individual
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Name [2]
283039
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Prof Doa El-Ansary - RMIT University, Melbourne Australia
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Address [2]
283039
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Country [2]
283039
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315326
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Research Ethics Commitee, National University of Malaysia
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Ethics committee address [1]
315326
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Sekretariat Etika Penyelidikan UKM Tingkat 1, Blok Klinikal, Pusat Perubatan UKM Jalan Yaakob Latiff, Bandar Tun Razak 56000 Cheras, Kuala Lumpur.
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Ethics committee country [1]
315326
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Malaysia
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Date submitted for ethics approval [1]
315326
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28/12/2023
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Approval date [1]
315326
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25/03/2024
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Ethics approval number [1]
315326
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JEP-2023-994
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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
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Trial website
None
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Nur Ayub Md Ali
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Address
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Heart and Lung Centre, Hospital Canselor Tuanku Muhkriz, Jalan Yaacob Latif Kuala lumpur, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia'.
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Country
134346
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Malaysia
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Phone
134346
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+60391454866
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Fax
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Email
134346
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[email protected]
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Contact person for public queries
Name
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Katijjahbe Md Ali
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Address
134347
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Heart and Lung Centre, Hospital Canselor Tuanku Muhkriz, Jalan Yaacob Latif Kuala lumpur, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia'.
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Country
134347
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Malaysia
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Phone
134347
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+60391454866
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Fax
134347
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Email
134347
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[email protected]
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Contact person for scientific queries
Name
134348
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Katijjahbe Md Ali
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Address
134348
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Heart and Lung Centre, Hospital Canselor Tuanku Muhkriz, Jalan Yaacob Latif Kuala lumpur, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia'.
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Country
134348
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Malaysia
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Phone
134348
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+60391454866
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Fax
134348
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Email
134348
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Participants number 1 to 78
Intervention grouping
individual outcome data
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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
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Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
For IPD meta-analyses,
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How or where can data be obtained?
Completion of trials when published. Data will be provided as supplementary appendix
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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.
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