None listed
Conditions
Brief summary
The purpose of the study is to determine if a strength-focused exercise program prior to surgery can improve participant’s physical function, reduce time in hospital and complications from surgery, and help restore physical function and quality of life post-surgery. Who is it for? You may be eligible for this study if you are an adult who is having surgery due to head and neck cancer at Fiona Stanley Hospital in Western Australia. Study details Participants in this study will receive one of three different treatments: 1. A ‘pre-habilitation’ exercise program, involving a strength and aerobic exercise program prior to surgery. Participants in this group will also receive an education program. 2. The same pre-habilitation program as group 1, plus an additional 6-week post-surgery rehabilitation program. 3. Usual care including an education program, and routine post-operative care. Participants in this study will be randomly allocated to one of these treatment groups, and will also need to complete a battery of physical function tests including a timed up and go test, grip strength, step test and DEXA scan. You will also need to complete a number of self reported questionnaires relating to your quality of life, quality of recovery and functional ability. It is hoped that this research will help determine if a pre-habiltiation program is effective at improving post-surgery outcomes in head and neck cancer patients.
Interventions
A 3 arm randomised controlled intervention trial will be conducted. ENT surgery patients will be randomised to either to 1) prehabilitation (pre-surgery) group, 2) prehabilitation (pre-surgery) + rehabilitation (post-surgery) group or 3) usual care group. A similar study, currently ongoing in general surgery patients has informed the logistics of recruitment and demonstrated the feasibility of pre- and post-operative measures as proposed below, including bio impedance analysis, isometric grip strength and QoL measures not routinely used in practice currently. This study design has been informed by Enhanced Recovery After Surgery (ERAS) best practice principles. The prehabilitation group (n=20) will involve an individualised exercise program (aerobic/resistance training + walking program), standardised education and engagement based on an in-person meeting at their first appointment at FSH. Patients will be invited to attend FSH or MU three times a week to undertake small group (<10 patients) gym-based resistance-focused exercises tailored to the patient, integrating a number of fitness activities with strength and functional training. Patients will complete 20 minutes of aerobic training (60-85% age predicted HR max) at the commencement of each gym based training session. The aerobic training will consist of various modes of exercise including treadmill, cycling and rowing ergometers. The strength training exercises will involve the large muscle groups that commence at 50% maximum voluntary contractions, as assessed by isometric dynamometry (Lafayette Muscle Meter, SI Instruments, Sth Australia). The gym based sessions will be supervised by either an Exercise Physiologist or Physiotherapist and last approximately 60 minutes. Patients will be provided a home walking program and diary to log their activity duration and sessional rating of perceived exertion (sRPE). Session attendance will be collected as will details of the weights lifted for each session. Following surgery this group will revert to usual post-operative care. As per inclusion criteria participants must have a scheduled surgery with a wait time >2 weeks therefore the prehabilitation program will run for at least 2 weeks (maximum of 6 weeks). Home based walking program: participants are encouraged to complete 150 minutes of moderate intense physical activity per week. For those in the usual care group, walking will be the selected mode of exercise. For the intervention groups participants will be asked to walk for 30mins on the days they do not attend the gym based exercise sessions. Standardised education: This takes place at the patient’s first visit and includes a one on one meeting with a senior physiotherapist who provides the patients with pamphlets on diet, exercise and lifestyle habits to achieve prior to surgery. This information/education pack is provided to all surgery patients at Fiona Stanley Hospital. The prehabilitation + rehabilitation group (n=20) will be identical to the prehabilitation group above, with the addition of a 6 week rehabilitation program (aerobic/resistance training + walking program) post-surgery. The 6 week rehabilitation program (post-surgery) will follow the same format as the prehabilitation program. This will consist of 3x 60minute gym based sessions per week supervised by the same staff responsible for the prehabilitation program. While the rehabilitation program aims to replicate the prehabilitation exercise program (same exercises/intensity etc.), the impact of surgery on each individual patient will be taken into consideration and exercises modified as required. Intensity prescribed post-surgery will commence low with the aim of returning to pre-surgery intensities if/when suitable. Individual session attendance will be documented and home based logs (detailing any home based walking) will be collected every 2 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
All general and head and neck cancer surgery patients at FSH with a predicted pre-operative lead time of 2 weeks or over. Patients undergoing pre-operative chemotherapy and/or radiotherapy at FSH will be recruited
Exclusion criteria
Any general and head and neck cancer surgery patients at FSH that have less than 2 week predicted lead time of their surgery. Patients that are unable to travel or access FSH to attend the three sessions of gym exercises per week will also be excluded.