None listed
Conditions
Brief summary
The purpose of this project is to investigate the effect of a resistance exercise intervention on muscle structure and function, health-related quality of life, activity behaviours and self-reported pelvic floor function in advanced-stage ovarian cancer survivors who have completed first-line treatment. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who has a confirmed diagnosis of stage III or IV epithelial ovarian cancer, for which you have completed first-line surgical and chemotherapy treatment at least four weeks and no more than three months ago. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group (immediate exercise group) will immediately receive supervised and home based-exercise training for 12 weeks. Participants in the other group (delayed exercise group) will receive usual care for 12 weeks, after which time they will be offered supervised and home-based exercise training for 12 weeks. The individualised exercise program consists of resistance training and flexibility exercises, and involves two 60 minute clinic-based supervised sessions and one 30 minute home-based session each week. Supervised sessions are conducted in small groups of 2-4 participants. All participants will be required to undergo various assessments prior to and following the intervention, in order to evaluate muscle structure, function and quality of life. Assessments include two different types of muscle scans, physical function tests, and completion of questionnaires. It is hoped that the study will contribute important new information that will be useful to clinicians and survivors in the ongoing management of ovarian cancer.
Interventions
The intervention is a 12-week resistance exercise program. (Resistance exercises are exercises that involve repetitive execution of selected movements against resistance). The exercise program involves two clinic-based supervised exercise sessions and one home-based exercise session each week for 12 weeks.
• Supervised exercise sessions will consist of a 5-minute warm-up on a stationary bike or treadmill, eight resistance exercises and flexibility exercises to conclude the session. Resistance e
The intervention is a 12-week resistance exercise program. (Resistance exercises are exercises that involve repetitive execution of selected movements against resistance). The exercise program involves two clinic-based supervised exercise sessions and one home-based exercise session each week for 12 weeks. • Supervised exercise sessions will consist of a 5-minute warm-up on a stationary bike or treadmill, eight resistance exercises and flexibility exercises to conclude the session. Resistance exercises will be done on weight machines and with free weights such as dumbbells. Exercises will include, unless contraindicated: leg press, leg extension, leg curl, calf raises (standing and seated), chest press, seated row or lat pull down, biceps curl and triceps extension.The intensity will be moderate to vigorous (i.e., somewhat hard to hard) and will be progressed by varying the amount of weight each participant lifts and how many times in a row she lifts it. Programs will be modified according to participants’ progress and how they are feeling. The supervised exercise sessions will be delivered face-to-face to small groups (2-4 participants/session) by an accredited exercise physiologist who has experience in working with people with cancer. Sessions will take approximately 60 minutes to complete and will take place in one of two university exercise clinics. • Home-based exercise sessions will be conducted at participants’ homes and consist of body weight resistance exercises and flexibility exercises. Additional, specific rehabilitation exercises will be prescribed to participants with pre-existing musculoskeletal conditions (such as lower back pain or a joint replacement). Participants will receive written material with details of their specific exercises, but will receive information regarding the correct execution of exercises in a face-to-face contact session with an accredited exercise physiologist who has experience in working with people with cancer. Exercise programs will be individualised based on each participant’s medical history and the results of the physical fitness and functioning assessment conducted before the start of the intervention. Exercise adherence will be monitored with individual exercise diaries. All participants will be asked to fill in information about the type, volume and intensity of exercises they completed at each session. The exercise physiologist supervising clinic-based sessions will remind participants at each session to complete daily diary entries.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women with histologically confirmed stages III and IV epithelial ovarian cancer who have completed first-line surgical and chemotherapy treatment at least four weeks and no more than three months prior to participation.
Exclusion criteria
Exclusion criteria: (1) age younger than 18 years, (2) inability to obtain approval from the treating gynaecological or medical oncologist or general practitioner, (3) inability to understand and speak English, (4) on anti- angiogenetic (Bevacizumab) treatment, (5) recurrent ovarian cancer, (6) existing or suspected bone metastasis, (7) acute illness or any musculoskeletal, cardiovascular or neurological disorder that could put participants at risk during exercise testing or exercise training, as determined by their specialist or general practitioner.
Outcome results
None listed