RecruitingACTRN12621000814875

Physiotherapy Prehabilitation for cancer surgery patients.

Does Physiotherapy led exercise Prehabilitation reduce cancer surgery patients’ length of stay and risk of post-operative complications?


Sponsor

Sir Charles Gairdner Hospital

Enrollment

38 participants

Start Date

Sep 8, 2020

Study Type

Interventional

Conditions

Summary

The purpose of this study is to determine whether a physiotherapist-led exercise prehabilitation program is effective in improving exercise tolerance, reducing hospital length of stay, and reducing post-operative complications in patients undergoing cancer surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are scheduled for complex surgery with a planned long anaesthetic time for upper gastrointestinal cancer, bowel cancer, or sarcoma. You will be included if you are receiving additional chemo radiation treatment or not. Study details All participants will receive a 6-week exercise program prior to surgery consisting of 2 sessions per week supervised by a physiotherapist. Sessions will be one hour in duration, and involve a walking program and resistance exercises using gymnasium equipment. The prescribed exercises will be tailored to each participant based on fitness levels assessed prior to the exercise program. Participants will complete a number of tests/questionnaires to assess exercise tolerance, frailty, strength, and quality of life before and after the 6-week exercise program, and will be monitored post-surgery until your hospital discharge date to record the length of stay in intensive care, time to mobilise out of bed, post-operative complications, and length of hospital stay. It is hoped that this study may demonstrate that an exercise prehabilitation program is effective at improving physical fitness and post-operative outcomes in patients undergoing complex cancer surgery.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Major cancer surgery — such as operations for stomach, bowel, or bone cancers — is physically demanding. Patients who are unfit or deconditioned going into surgery face higher risks of complications and longer recovery times. Prehabilitation is the concept of getting fitter before surgery, rather than only focusing on rehabilitation afterwards. This study tests whether a structured physiotherapy-led exercise program in the 6 weeks before surgery improves fitness and recovery. Participants will attend 2 supervised sessions per week at a gym, completing walking and resistance exercises tailored to their individual fitness levels. Researchers will track exercise capacity, frailty, strength, and quality of life before surgery, and monitor hospital stay length, intensive care time, and post-operative complications after the operation. You may be eligible if you are 18 or older, are scheduled for complex cancer surgery (upper gastrointestinal, bowel, or sarcoma) in 6 weeks or more, and have been assessed as having low physical fitness. People whose surgery is scheduled in less than 6 weeks, those who are neutropenic, cannot participate in group exercise, weigh over 150kg, or have cognitive impairment or significant mental illness would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will participate in an initial assessment conducted by a senior physiotherapist to determine baseline exercise tolerance and other descriptors. This includes a 6 minute walking test (6MWT

Participants will participate in an initial assessment conducted by a senior physiotherapist to determine baseline exercise tolerance and other descriptors. This includes a 6 minute walking test (6MWT) and a balance/frailty assessment called a short physical performance battery (SPPB). A quality of life survey (QLQ C30) will also be assessed at this time. They will then participate in a 2x weekly, one hour in length duration tailored supervised exercise program. This is conducted by a senior physiotherapist and 4th year physiotherapy students from Curtin University. Participants recruited may be currently receiving neoadjuvant chemoradiotherapy (CRT), have finished CRT on not completing CRT. The intervention is carried out despite their current CRT as to not impact on their cancer care. It has already been proven that exercise is safe at any point within the patients' treatment journey and this is why this approach was taken. The program will consist of a walking program (determined from their 6MWT result) and resistance exercises via standard gymnasium equipment. The program is run as a group class, with a maximum of 10 participants per class. Their program will be documented and progressed / regressed as deemed appropriate by the supervising physiotherapist. The participants will be asked to exercise at a 'moderate intensity' which is described as 'difficulty walking and talking'. The walking program is implemented on a flat walking track within the hospital, and resistance exercises are completed on standard gymnasium equipment in the Physiotherapy gym. These include, upper limb exercise with free weights, sit to stand, step ups, calf raises, body weight push up, large muscle group exercise on gym equipment (leg press, latissimus dorsi pull down, tricep push, Smith machine etc). At the end of the 6 week program, the physiotherapist will repeat the initial assessment as a discharge assessment. As patients CRT treatment time / time to surgery differs for each surgical group - patients attend the surgical gym class for 6 weeks which is usually between 1-2 weeks pre-op. Adherence to the program is monitored via WebPAS - on online booking system used by the Physiotherapy clerks. Adherence is measured as appointments attended. Once the patient is discharged from hospital, we will record the patients’ length of stay in ICU and in hospital and post-operative complications occurred during their inpatient stay. If required, medical records will be pulled to allow for data collection.


Locations(1)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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ACTRN12621000814875


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