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Trial registered on ANZCTR
Registration number
ACTRN12625000023459
Ethics application status
Approved
Date submitted
3/09/2024
Date registered
15/01/2025
Date last updated
15/01/2025
Date data sharing statement initially provided
15/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The Effect of High-Intensity Interval Training versus Moderate Intensity Continuous Training in Prehabilitation among Patients Undergoing Upper Abdominal Surgery.
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Scientific title
The Effect of High-Intensity Interval Training versus Moderate Intensity Continous Training in Prehabilitation over Physical Function among Patients Undergoing Upper Abdominal Surgery.
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Secondary ID [1]
312882
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NIL
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Universal Trial Number (UTN)
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Trial acronym
PEFAST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
upper abdominal surgery
335037
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Condition category
Condition code
Physical Medicine / Rehabilitation
331776
331776
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0
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Physiotherapy
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Surgery
331787
331787
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This will be a tailored and supervised by a single Physiotherapist (more than 10 years clinical experiences in cardiorespiratory) in outpatient hospital setting. Participants will engage in a graduated aerobic, strengthening exercise and inspiratory muscles training program prior to the date of their surgery.
For aerobic exercise this will be a moderate intensity which is 55-75% of maximum heart rate (MHR) in week one with graduation to high intensity in week 2 on < 80% of MHR. Aerobic exercise training (eg: Treadmill, Cycle ergometer, body weight exercises) 1-3 times per week (30 minutes) for overall duration typical 2-4 week prior to date of surgery. Patients’ Maximum Heart rate (210-age) and Karvonen Formula will be used for targeted heart rate. Patients’s heart rate will be monitored along the aerobic training using smartwatch. The interval training will be 30-60 seconds of high intensity training with 1- 2 minutes of active recovery (light activity or complete rest) between intervals to facilitate recovery. Repeat for a total of 5-10 cycles. Aim for a total session duration of about 20-30 minutes, including warm-up and cool-down. This include 10-15 minutes of HIIT, depending on the patient's tolerance. Sessions will be done 1-3 times per week, with rest days in between to allow for recovery.
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. The intensity will be 70-80% of estimated 10 repetitions maximum.The load not provided 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.
Inspiratory muscles training will be given 20 mins per day with 30% of maximum inspiratory pressure (MIP)
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. Detailed session attendance checklist and vital sign will be recorded for every attendance for adherence monitoring
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Intervention code [1]
329423
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Rehabilitation
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Comparator / control treatment
This will be a tailored and supervised by a single Physiotherapist (more than 10 years clinical experiences in cardiorespiratory) in outpatient hospital setting. Participants will engage in an aerobic (moderate intensity continuous training), strengthening exercise and inspiratory muscles training program prior to the date of their surgery.
For aerobic exercise this will be a low intensity in week one with graduation to moderate intensity. Moderate intensity continuous training (MICT) will allow 55-75% of maximum heart rate (MHR). Aerobic exercise training (eg: treadmill, cycling, walking exercise ) 2-3 times per week (60 minutes) for overall duration typical 2-4 week prior to date of surgery. Patients’ Maximum Heart rate (210-age) and Karvonen Formula will be used for targeted heart rate. Patients’s heart rate will be monitored along the aerobic training using smartwatch. Aim for a total session duration of about 45-60 minutes, including warm-up and cool-down. This include 30-45 minutes minutes of MICT, depending on the patient's tolerance. Sessions will be done 1-3 times per week.
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. The intensity will be 70-80% of estimated 10 repetitions maximum.The load not provided 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.
Inspiratory muscles training will be given 20 mins per day with 30% of maximum inspiratory pressure (MIP)
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. Detailed session attendance checklist and vital sign will be recorded for every attendance for adherence
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Control group
Dose comparison
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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]
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Cardiorespiratory Fitness
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Assessment method [2]
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maximal insoiratory pressure (MIP) using power breath K2
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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 (primary timepoint) post-discharge
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Secondary outcome [1]
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Physical function
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Assessment method [1]
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Short Physical Performance Battery (SPPB)
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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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Functional assessment
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Assessment method [2]
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1 minute Sit to Stand
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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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Anxiety
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Assessment method [3]
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Hospital Anxiety and Depression Scale
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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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upper limb strength
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Assessment method [4]
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dynamometer hand grip test
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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]
440340
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Depression
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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 (T1), before operation (T2), before discharge (T3), 4 week post operation (T4), 12 week post operation (T5)
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Secondary outcome [6]
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Health-related QoL
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Assessment method [6]
440341
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EQ-5D-5L
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Timepoint [6]
440341
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Baseline (T1), before operation (T2), before discharge (T3), 4 week post operation (T4), 12 week post operation (T5)
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Secondary outcome [7]
440342
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body composition
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Assessment method [7]
440342
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Bioimpedence test
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Timepoint [7]
440342
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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]
440343
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fatigue
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Assessment method [8]
440343
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Fatigue severity scale
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Timepoint [8]
440343
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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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physical capacity
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Assessment method [9]
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Self Administered Questionnaire (SAQ)
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Timepoint [9]
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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
• Adults aged 18 years years old and over
• Scheduled for upper abdominal surgery.
• Able to perform the Six-Minute Walk Test (6MWT).
• 6MWT distance between 300-450 meters (moderate risk) or >450 meters (low risk).
• Provide written informed consent.
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Minimum age
18
Years
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Maximum age
70
Years
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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 or severe comorbidities that contraindicate exercise (e.g., unstable cardiovascular disease).
• Impaired cognition or confusion
• Impaired vision, cognition or physical impairment (UL and LL) in functional task components
• 6MWT distance <300 meters (high risk).
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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)
central randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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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
The sample size was calculated using primary outcome measure (6MWT). Sample size calculation based on data from previous study which examine 6MWT. With consideration for MCID changes in 6MWT performed by patients with pathology is 30 meter (Bahanon 2016). By using G-power with type 1 error rate for 0.9 and alpha 0.05. Total sample size calculated is n=46,. Considering 30% of the dropout rate, 60 participants will be recruited with 30 participants in each group for the RCT
Statistical analyses will be performed using the Statistical Package for Social Sciences version 22.0 for Windows and directed by the UKM statistical consulting unit. Descriptive statistics including mean and SD; median and interquartile range; number and percentage; and frequency will be used to summarize data (depending on distribution and type of data): this includes participant demographics. Differences between groups at baseline will be compared using an Independent-samples t-test and Mann-Whitney U test for parametric and non-parametric data respectively. Changes in outcome variables over time will be analysed with repeated measures analysis of variance (ANOVA) or nonparametric equivalent (Kruskall Wallis) comparing different assessment time points. Specific aspects will be examined, such as time effects, group effects, and interaction effects. Magnitude of difference between the two groups will be determined by utilised the Cohen's D. Simple effect analysis will be used to identify specific differences between time points. For all tests p<0.05 will be considered statistically significant and confidence interval 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
1/02/2025
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Actual
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Date of last participant enrolment
Anticipated
4/07/2026
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Actual
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Date of last data collection
Anticipated
5/11/2026
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26539
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Malaysia
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State/province [1]
26539
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Funding & Sponsors
Funding source category [1]
317323
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Hospital
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Name [1]
317323
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Hospital Canselor Tuanku Muhriz
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Address [1]
317323
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Country [1]
317323
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Malaysia
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Primary sponsor type
University
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Name
Universiti kebangsaan Malaysia
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Address
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Country
Malaysia
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Secondary sponsor category [1]
319605
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None
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Name [1]
319605
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Address [1]
319605
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Country [1]
319605
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316053
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Research Ethic Committee, National University of Malaysia
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Ethics committee address [1]
316053
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Sekretariat Etika Penyelidikan Universiti Kebangsaan Malaysia, Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Pusat Perubatan UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras Kuala Lumpur.
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Ethics committee country [1]
316053
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Malaysia
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Date submitted for ethics approval [1]
316053
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05/08/2024
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Approval date [1]
316053
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12/11/2024
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Ethics approval number [1]
316053
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JEP-2024-527
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Summary
Brief summary
The primary purpose of this study is to investigate high intensity interval training (HIIT) compared to moderate intensity interval training (MICT) on cardiorespiratory fitness (6MWT) and Inspiratory muscle strength (MIP) among patient undergoing for upper abdominal surgery. The hypothesis is HIIT exercise is effective in improving Cardiorespiratory Fitness, physical performance,fatigue, psychological recovery and health-related quality of life compared to standard care (MICT)Both groups will receive body conditioning and respiratory muscle strength exercises. For the intervention group, participants will receive HIIT and the control group MICT. This will be one-hour therapist-supervised intervention sessions for at least 4 weeks of exercise duration with 2 sessions per week before the surgery. The patient will be assessed at baseline, before the operation, before discharge and 4 weeks postoperatively and 3 months postoperatively. The outcomes will be assessed using multi-domain recovery measures that include physical measures (6MWT), Short Physical Performance Battery and 1 minute Sit to Stand), upper limb strength (Hand Grip Test), fatigue (Fatigue Severity Scale), psychological recovery (the Hospital Anxiety Depression Scale (HADS) and health-related quality of life (EuroQoL). Data will be analysed using intention-to-treat analysis. The changes from all timelines in the secondary outcomes will be analysed using the ANOVA test.
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Trial website
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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 bin Mohd Ali
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Address
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Jabatan Surgeri Tingkat 8, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur.
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Country
136626
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Malaysia
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Phone
136626
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+60123177845
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Fax
136626
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Email
136626
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drnurayub@gmail.com
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Contact person for public queries
Name
136627
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katijjahbe Md Ali
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Address
136627
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Physiotherapy Unit, JPPP, Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur.
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Country
136627
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Malaysia
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Phone
136627
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+601110253818
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Fax
136627
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Email
136627
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katijjahbe@yahoo.com
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Contact person for scientific queries
Name
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katijjahbe Md Ali
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Address
136628
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Physiotherapy Unit, JPPP, Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur.
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Country
136628
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Malaysia
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Phone
136628
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+601110253818
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Fax
136628
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Email
136628
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katijjahbe@yahoo.com
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Case-by-case basis at the discretion of Primary Sponsor
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
Participants number 1 to 60
Intervention grouping
individual outcome data
What types of analyses could be done with individual participant data?
•
For IPD meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
Completion of trials when published December 2027 (start date 1/1/2025- 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
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
completion of trials when published. Data will be provided as supplementary appendix
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
JEP-2024-527.pdf
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.
Download to PDF