None listed
Conditions
Brief summary
The purpose of this study is to investigate the feasibility, safety and acceptability of a Pilates exercise intervention for adults living with advanced cancer. Additionally, the aim is to also understand the impact of a Pilates exercise intervention on the strength, balance, physical activity, quality of life and sleep quality of adults living with advanced cancer. Who is it for? This study is for adults aged 18 years and older living with a confirmed diagnosis of an advanced cancer who are able to attend and perform Pilates in-person and on-line (telehealth) across 8 weeks. Participants must not currently be engaging in structured exercise for more than 2x per week over the previous 3 months. Study details Participants will be randomised to either attend Pilates intervention or to continue to receive usual care. Participants allocated to the Pilates intervention will undertake 2x 60 minute supervised mat-based Pilates sessions per week for 8-weeks, delivered by a certified Pilates instructor who is also an accredited exercise physiologist. Sessions are in a small group format of up to 3 participants per class, and each week one of the two sessions will be delivered in-person (face-to-face) while the second session will be delivered on-line (telehealth). Participants in this study will completed a variety of physical tests, including but not limited to: grip strength test, sit-to-stand test, up-and-go test, balance. Participants will also be asked to complete questionnaires to assess quality of life, sleep, and physical activity. It is hoped that the findings from this study will help determine whether Pilates could become a practical component of cancer rehabilitation programs and inform the design of a larger clinical trial.
Interventions
Intervention group: Pilates Exercise Program
Participants allocated to the intervention group will undertake an 8-week supervised Pilates mat-based exercise program delivered by an accredited exercise physiologist who is also a certified Pilates instructor. The Pilates intervention will comprise:
2 supervised Pilates sessions per week for 8 weeks, 60 minutes per session, 1 face-to-face session weekly, and 1 telehealth session weekly. Small group format (approx. 3–5 participants per class). Deliv
Intervention group: Pilates Exercise Program Participants allocated to the intervention group will undertake an 8-week supervised Pilates mat-based exercise program delivered by an accredited exercise physiologist who is also a certified Pilates instructor. The Pilates intervention will comprise: 2 supervised Pilates sessions per week for 8 weeks, 60 minutes per session, 1 face-to-face session weekly, and 1 telehealth session weekly. Small group format (approx. 3–5 participants per class). Delivered at Southern Cross University, and online via telehealth. Exercises will be individualised and modified according to participant ability, symptoms, and safety, and progression is individualised. Exercise intensity will be monitored through Rating of Perceived Exertion (RPE). Symptom monitoring adherence and compliance will be monitored (i.e., session attendance, drop out, drop out reason, and study completion rate). Any adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) V6.0 (National Cancer Institute, 2017) and reported. Examples of Pilates exercises that will be prescribed as part of the intervention include: Bridging, dead bugs, arm arcs, chest lift, side to side, book openings, prone spine extension, quadruped and standing roll down.
Sponsors
Southern Cross University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adults aged 18 years and older - Confirmed diagnosis of advanced cancer - Not participating in structured exercise greater than or equal to twice/week during previous 3 months - Able to attend Southern Cross University at least once weekly - Medical clearance to undertake Pilates exercise intervention - Adequate English language skills - Capacity to provide informed consent - Access to a device capable of telehealth participation - Participants receiving active cancer treatment or not on treatment are eligible
Exclusion criteria
- Inability to understand study procedures or provide informed consent - Contraindications to exercise determined by treating clinician - Severe cardiovascular, musculoskeletal or medical conditions precluding participation - ECOG performance status > 2 - CTCAE > Grade 2 - Current moderate-to-severe bone pain - Already achieving recommended cancer-specific exercise levels
Outcome results
None listed