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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.
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.
Secondary ID [1] 312882 0
NIL
Universal Trial Number (UTN)
Trial acronym
PEFAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
upper abdominal surgery 335037 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331776 331776 0 0
Physiotherapy
Surgery 331787 331787 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 329423 0
Rehabilitation
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
Control group
Dose comparison

Outcomes
Primary outcome [1] 339286 0
cardiorespiratory fitness
Timepoint [1] 339286 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] 340178 0
Cardiorespiratory Fitness
Timepoint [2] 340178 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] 439375 0
Physical function
Timepoint [1] 439375 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] 440337 0
Functional assessment
Timepoint [2] 440337 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] 440338 0
Anxiety
Timepoint [3] 440338 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] 440339 0
upper limb strength
Timepoint [4] 440339 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] 440340 0
Depression
Timepoint [5] 440340 0
Baseline (T1), before operation (T2), before discharge (T3), 4 week post operation (T4), 12 week post operation (T5)
Secondary outcome [6] 440341 0
Health-related QoL
Timepoint [6] 440341 0
Baseline (T1), before operation (T2), before discharge (T3), 4 week post operation (T4), 12 week post operation (T5)
Secondary outcome [7] 440342 0
body composition
Timepoint [7] 440342 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] 440343 0
fatigue
Timepoint [8] 440343 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] 443179 0
physical capacity
Timepoint [9] 443179 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
• 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

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)
central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
4/07/2026
Actual
Date of last data collection
Anticipated
5/11/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26539 0
Malaysia
State/province [1] 26539 0

Funding & Sponsors
Funding source category [1] 317323 0
Hospital
Name [1] 317323 0
Hospital Canselor Tuanku Muhriz
Country [1] 317323 0
Malaysia
Primary sponsor type
University
Name
Universiti kebangsaan Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 319605 0
None
Name [1] 319605 0
Address [1] 319605 0
Country [1] 319605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316053 0
Research Ethic Committee, National University of Malaysia
Ethics committee address [1] 316053 0
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.
Ethics committee country [1] 316053 0
Malaysia
Date submitted for ethics approval [1] 316053 0
05/08/2024
Approval date [1] 316053 0
12/11/2024
Ethics approval number [1] 316053 0
JEP-2024-527

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136626 0
A/Prof Nur Ayub bin Mohd Ali
Address 136626 0
Jabatan Surgeri Tingkat 8, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur.
Country 136626 0
Malaysia
Phone 136626 0
+60123177845
Fax 136626 0
Email 136626 0
[email protected]
Contact person for public queries
Name 136627 0
katijjahbe Md Ali
Address 136627 0
Physiotherapy Unit, JPPP, Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur.
Country 136627 0
Malaysia
Phone 136627 0
+601110253818
Fax 136627 0
Email 136627 0
[email protected]
Contact person for scientific queries
Name 136628 0
katijjahbe Md Ali
Address 136628 0
Physiotherapy Unit, JPPP, Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur.
Country 136628 0
Malaysia
Phone 136628 0
+601110253818
Fax 136628 0
Email 136628 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 60
Intervention grouping
individual outcome data
When will data be available (start and end dates)?
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
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24429Ethical approval    388392-(Uploaded-06-01-2025-22-11-31)-JEP-2024-527.pdf



Results publications and other study-related documents

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