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Feasibility and acceptability of pre-operative exercise to improve patient outcomes after major pelvic cancer surgery: A pilot randomised controlled trial.

Feasibility and acceptability of pre-operative exercise to improve patient outcomes after major pelvic cancer surgery: A pilot randomised controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001129370
Acronym
PEPA Trial
Enrollment
22
Registered
2017-08-01
Start date
2017-10-10
Completion date
2018-10-18
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this trial is to evaluate the feasibility and acceptability of a pre-operative exercise program in people undergoing major pelvic cancer surgery. Who is it for? You may be eligible to enrol in this trial if you are aged 18-80 years and are scheduled to undergo major pelvic cancer surgery. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either the exercise program or to receive usual care. Participants allocated to the exercise program will receive a supervised one hour one-on-one exercise session once per week for 2-6 weeks, occurring prior to surgery. They will also be asked to complete the hour-long exercise session at home four days per week in addition to 150 minutes of moderate exercise (walking, cycling, etc.) per week. Following surgery, participants will be asked for their opinion of the exercise program, and some additional tests and questionnaires will also be completed to assess physical activity, strength, complications and other outcomes following surgery. It is hoped that the findings from this trial will provide information on whether the pre-operative exercise program is feasible and acceptable to participants, as well as providing preliminary data on the efficacy of the program for improving health outcomes following major pelvic cancer surgery.

Interventions

Pre-operative exercise programme: The exercise programme will consist of 60 minutes individualised (one-to-one) training session with a registered physiotherapist, once a week, for 2 to 6 weeks (maximal of 6 sessions) before the patient undergoes their scheduled surgery. The last day of exercise will be the day before the patient undergoes surgery. The duration (2-6 weeks), specific exercises performed and intensity of the exercise programme will all be tailored to each patient through a health

Pre-operative exercise programme: The exercise programme will consist of 60 minutes individualised (one-to-one) training session with a registered physiotherapist, once a week, for 2 to 6 weeks (maximal of 6 sessions) before the patient undergoes their scheduled surgery. The last day of exercise will be the day before the patient undergoes surgery. The duration (2-6 weeks), specific exercises performed and intensity of the exercise programme will all be tailored to each patient through a health assessment, taking into consideration their current health status, physical activity level, co-morbidities and medical history. Each session will consist of 10 minutes of warm-up (walking and cycling), 40 minutes of aerobic and endurance exercises (such as cycling, treadmill and rower activity), respiratory and muscle strength exercises (breathing and weights training), and 10 minutes cool down (stretches and flexibility exercises). The aerobic and endurance exercises will be performed at 40% to 60% of the maximum heart rate and the strength training will be performed at an intensity of 40% to 60% of the one repetition maximum. Participant will be given instruction and recommendations on how to complete and progress these exercises (or similar exercises) at home (4 sessions x 60 minutes at home per week, up to the scheduled date of surgery). Furthermore, apart from the prescribed exercises, participants will be recommended to engage in moderate-intensity exercise for at least 150 minutes per week (such as walking or cycling). Home exercises will be captured in a daily exercise diary that participants will complete until the end of the exercise programme.

Sponsors

Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

To be eligible for the study, patients will be adults aged 18-80 years :: (a) Undergoing elective major advanced or recurrent gastrointestinal cancer surgery; (b) Present at a gastrointestinal surgeon at least 2 weeks prior to planned surgery.

Exclusion criteria

Patients will be excluded from the study if they have: (a) Cognitive impairment such that they are unable to give informed consent; (b) Co-morbidity preventing participation in exercise (i.e. major cardiac, respiratory or musculoskeletal disease); (c) Inadequate English to complete outcome measures or understand verbal instructions; (d) Current participation in an exercise programme similar to the proposed intervention. (e) Unable to attend exercise program (e.g. living in other state).

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026