None listed
Conditions
Brief summary
The aim of this study is to test a telehealth-delivered, stoma-specific exercise and physical activity program, establishing whether the delivery of physical activity via telehealth is feasible, acceptable and safe for this group. Who is it for? You may be eligible for this study if you are a male or female age 18 or older, who have received a stoma as a result of cancer in the five years prior to enrolment. Stoma is either permanent or long-term. Have access to the internet and own, or have access to a computer or tablet device. Study details Participants will receive a stoma-specific exercise intervention delivered via telehealth. Intervention material will include an exercise manual, web-based exercise videos and guides, and a one-hour individual telehealth exercise and coaching session each week with a stoma-trained exercise professional for 12-weeks. Participants will also be encouraged to undertake self-managed sessions twice weekly, to accumulate three organised exercise sessions and progress towards a minimum physical activity target of equal to or greater than 150 minutes per week. Each exercise session will constitute three primary components: Soma-specific strengthening, aerobic exercise, and resistance exercise. After commencement of the intervention, participants will be asked to respond to questionnaires regarding acceptability and quality of life, safety data and feasibility data will be collected during the intervention. It is hoped that findings from this study will enhance physical activity and quality of life in people with a stoma following cancer.
Interventions
The intervention will comprise of a stoma-specific exercise intervention that can be delivered in a remote, telehealth setting. Intervention material will include an exercise manual, web-based exercise videos and guides, and a one-hour individual telehealth exercise and coaching session each week with a stoma-trained exercise professional (ExP), for 12-weeks. Participants will also be encouraged to undertake self-managed sessions twice weekly, to accumulate three organised exercise sessions and progress towards a minimum physical activity target of equal to or greater than 150 minutes per week, consistent with Australian Physical Activity and Exercise Guidelines for Adults. Initial exercise dose and progression will be prescribed based on a baseline assessment that will address the participants needs, stoma specific considerations or barriers to exercise, current ability, and current exercise efficacy. These consults will also allow for ExP-mediated discussions to identify and address current perceived barriers to exercise and safety concerns. Each exercise session will constitute three primary components: Stoma-specific strengthening, aerobic exercise, and resistance exercise. Stoma-specific exercises have been developed and tested elsewhere, and will be adapted for inclusion in the present study aligned with participant capability and goals. Exercise equipment including TheraBands and dumbbells will be provided as needed. Aerobic and resistance-based exercise prescription will adhere to Exercise and Sports Science Australia recommendations. In the present study, resistance training will utilise repetitions in reserve (RIR) to regulate intensity, with 1-4 used as a target intensity for a given set. For the aerobic component, moderate intensity exercise or physical activity prescription may be utilised by ExPs in cases where high intensity interval training (HIIT) is considered either not suitable or is not a preferred modality of a participant. Attention will be extended to perceived barriers to exercise and risk factor management through education and exercise counselling. FOXTROT Exercise Training Session Outline Stoma Specific Strength: 2-3 sets of 2-3 stoma-specific strengthening exercises. Progress from Level 1 to Level 3 across the intervention. Participants will be given materials that include videos demonstrating exercises for activating the body core and abdominal muscles and instructions on techniques and breathing for these exercises, as per the Hernia Active Living Trial (Hubbard et al,. 2020) Resistance Exercise: 2 – 3 sets of 8-12 repetitions; 30-60 seconds of rest between sets; Target intensity: 1-4 RIR; utilising upper and lower body strength exercises e.g., push-up and squat. Aerobic Exercise: HIIT, MICT, or PA HIIT: 5 min warm up 4 min HII 3 min recovery 4 min HII 3 min cooldown MICT: 20-30 min moderate intensity (50-80% HR peak) PA: Accumulate 150 minutes of MVPA HII, High intensity interval; HIIT, High intensity interval training; HR, Hear rate; MICT, Moderate intensity continuous training; MVPA, Moderate to vigorous physical acidity; PA, Physical activity; RIR, Repetitions in reserve; 1RM, One repetition maximum Exercise attendance and adherence will be recorded during exercise consults by the delivering ExP. This will include recording of the current exercise session, with notation of exercise dose and exercise selection (intensity, sets, reps, time of aerobic exercise), as well as prescription of an unsupervised session to be conducted in the same week. At the subsequent exercise consult, the ExP will retrospectively record participant adherence and attendance to this unsupervised session via participant self-report. Reasons for non-adherence will be recorded, and stoma specific barriers and concerns that may contribute to either modification of exercise prescription or non-adherence will also be recorded. Any AEs will also be recorded during ExP consults and facilitate identification of study relatedness and severity. One-week additional time may be allocated to participants that need to postpone exercise for any reason during the intervention; i.e., 13-weeks will be allowed to complete the 12-week intervention. Any exercise consults or “missed” exercise sessions that cannot be included in this time will inform the feasibility and acceptability assessment of the program
Sponsors
Study design
Eligibility
Inclusion criteria
1. Men and women 18 years and older, treated for cancer and who have received a stoma in the five years prior to enrolment (stoma formed at Uniting Care hospital) 2. More than six weeks since stoma surgery 3. Stoma is either permanent or long-term (in situ for greater than or equal to 26 weeks) 4. Stoma was received as a result of cancer and/or its treatments 5. Cancer treatment may be completed or ongoing 6. Reside in Australia 7. Have access to the internet and own, or have access to, a computer or tablet device 8. Willing and able to comply with all study requirements, including intervention, timing and nature of required assessments 9. Able to speak and read in English, or have access to English translation via a friend or family member, to ensure consent is informed and documentation of participant-reported outcomes measures can be adhere do. 10. Can provide voluntary informed consent
Exclusion criteria
1. Stoma was received in treatment of a diagnosis alternative to cancer (e.g. Irritable Bowel Disease, Crohn’s disease) 2. Any clinical contraindication that precludes safe completion of the program in the judgement of the project team