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Trial registered on ANZCTR
Registration number
ACTRN12619000261112
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
20/02/2019
Date last updated
13/02/2020
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of resistance exercise on muscle in advanced-stage ovarian cancer survivors who have completed first line treatment: A pilot randomised controlled trial
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Scientific title
The effect of a supervised resistance exercise intervention on muscle morphology in advanced-stage epithelial ovarian cancer survivors who have completed first line treatment: A pilot randomised controlled trial
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Secondary ID [1]
297081
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian cancer
311620
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Condition category
Condition code
Cancer
309721
309721
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0
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Ovarian and primary peritoneal
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Physical Medicine / Rehabilitation
310244
310244
0
0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
313356
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Treatment: Other
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Intervention code [2]
313357
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Rehabilitation
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Comparator / control treatment
Comparator treatment for the 12-week intervention period will involve "standard care" for women who have completed first-line treatment for ovarian cancer. "Standard care" in this case will mostly involve clinician surveillance while women recovery from cancer and cancer treatment. Following the post-intervention assessment, control participants will be offered supervised and home-based exercise training for 12 weeks. The structure and content of the exercise program for the Control (Delayed Exercise) Group will be similar to that of the Experimental (Immediate Exercise) Group.
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Control group
Active
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Outcomes
Primary outcome [1]
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Muscle mass as assessed with dual-energy x-ray absorptiometry (DEXA) and peripheral quantitative computed tomography (pQCT) scans
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Assessment method [1]
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Timepoint [1]
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Baseline and one to two weeks after completion of 12-week intervention (primary timepoint)
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Primary outcome [2]
318689
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Muscle density as assessed with peripheral quantitative computed tomography (pQCT) scans
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Assessment method [2]
318689
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Timepoint [2]
318689
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Baseline and one to two weeks after completion of 12-week intervention (primary timepoint)
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Secondary outcome [1]
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Mobility as assessed as a composite of the 400 m corridor walk and 6 m usual pace walk
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Assessment method [1]
365734
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Timepoint [1]
365734
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Baseline and one to two weeks after completion of 12-week intervention
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Secondary outcome [2]
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Mobility and dynamic balance as assessed with a Timed Up and Go (TUG) test
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Assessment method [2]
365735
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Timepoint [2]
365735
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Baseline and one to two weeks after completion of 12-week intervention
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Secondary outcome [3]
365736
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Upper body muscular strength as assessed with a one-repetition maximum (1-RM) chest press
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Assessment method [3]
365736
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Timepoint [3]
365736
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Baseline and one to two weeks after completion of 12-week intervention
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Secondary outcome [4]
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Lower body muscular strength as assessed with a 5-RM leg press
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Assessment method [4]
365737
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Timepoint [4]
365737
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Baseline and one to two weeks after completion of 12-week intervention
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Secondary outcome [5]
367134
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Handgrip strength as assessed with a handgrip strength test done with a handgrip dynamometer
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Assessment method [5]
367134
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Timepoint [5]
367134
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Baseline and one to two weeks after completion of 12-week intervention
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Secondary outcome [6]
367135
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Objective activity behaviors (objective physical activity and sedentary time) as assessed with accelerometers - composite secondary outcome
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Assessment method [6]
367135
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Timepoint [6]
367135
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Baseline and one to two weeks after completion of 12-week intervention
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Secondary outcome [7]
367136
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Health-related quality of life as assessed with the with the European Organisation for Research and Treatment of Cancer (EORTC) cancer-specific health-related QoL questionnaire (QLQ-C30) and supplementary ovarian cancer specific questionnaire (QLQ-OV28)
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Assessment method [7]
367136
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Timepoint [7]
367136
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Baseline and one to two weeks after completion of 12-week intervention
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Secondary outcome [8]
367137
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Self-reported pelvic floor function as assessed with the Australian Pelvic Floor Questionnaire
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Assessment method [8]
367137
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Timepoint [8]
367137
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Baseline and one to two weeks after completion of 12-week intervention
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed as central randomisation will be done by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample Size Calculation:
To undertake the trial with 80% power at an alpha level of 0.05 (two-tailed tests) and to detect a large effect size (d = 1.0) which we would consider to be clearly meaningful, 16 participants per group are required. In order to account for an attrition of up to 20% in each group we will aim to recruit 40 participants (20 participants per group) over the course of two years.
Data analyses will include:
Standard descriptive statistics
Pearson Chi square, independent t-tests or Mann-Whitney U tests to assess baseline differences between groups
ANCOVA (controlling for baseline values) to assess differences from baseline to post-intervention
Effect sizes - small (r = 0.10 – 0.29), moderate (r = 0.30 – 0.49) & large (r = 0.50 – 1.00)
Associations - Pearson’s or Spearman’s Correlation Coefficient
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/03/2020
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Actual
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Date of last participant enrolment
Anticipated
15/01/2021
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Actual
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Date of last data collection
Anticipated
30/04/2021
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Actual
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Sample size
Target
40
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
12921
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St John of God Hospital, Subiaco - Subiaco
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Recruitment hospital [2]
12922
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
25396
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6008 - Subiaco
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Recruitment postcode(s) [2]
25397
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
301649
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University
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Name [1]
301649
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Edith Cowan University
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Address [1]
301649
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270 Joondalup Dr, Joondalup WA 6027
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Country [1]
301649
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Australia
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Funding source category [2]
301975
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Charities/Societies/Foundations
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Name [2]
301975
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Cancer Council Western Australia (WA)
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Address [2]
301975
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Cancer Council WA Head Office
420 Bagot Rd, Subiaco WA 6008
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Country [2]
301975
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Australia
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Primary sponsor type
University
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Name
Edith Cowan University
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Address
270 Joondalup Dr, Joondalup WA 6027
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Country
Australia
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Secondary sponsor category [1]
301360
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Hospital
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Name [1]
301360
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St John of God Subiaco Hospital
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Address [1]
301360
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12 Salvado Rd, Subiaco WA 6008
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Country [1]
301360
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Australia
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Secondary sponsor category [2]
301695
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Hospital
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Name [2]
301695
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Sir Charles Gairdner Hospital
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Address [2]
301695
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Hospital Ave, Nedlands WA 6009
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Country [2]
301695
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302370
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St John of God Health Care Human Research Ethics Committee
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Ethics committee address [1]
302370
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St John of God Health Care Human Research Ethics Committee
C/o St John of God Subiaco Hospital
12 Salvado Road
Subiaco Western Australia 6008
[email protected]
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Ethics committee country [1]
302370
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Australia
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Date submitted for ethics approval [1]
302370
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05/03/2019
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Approval date [1]
302370
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12/04/2019
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Ethics approval number [1]
302370
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Ethics committee name [2]
302629
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Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
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Ethics committee address [2]
302629
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Sir Charles Gairdner Hospital
2nd Floor, A Block (Mailbox 26)
Hospital Ave, Nedlands WA 6009
[email protected]
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Ethics committee country [2]
302629
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Australia
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Date submitted for ethics approval [2]
302629
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26/03/2019
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Approval date [2]
302629
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28/11/2019
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Ethics approval number [2]
302629
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Christelle Schofield
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Address
89990
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Edith Cowan University Exercise Medicine Research Institute
Joondalup Campus, Building 21, Level 2
270 Joondalup Dr, Joondalup WA 6027
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Country
89990
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Australia
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Phone
89990
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(61 8) 6304 3444
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Fax
89990
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Email
89990
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[email protected]
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Contact person for public queries
Name
89991
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Mrs Christelle Schofield
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Address
89991
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Edith Cowan University Exercise Medicine Research Institute
Joondalup Campus, Building 21, Level 2
270 Joondalup Dr, Joondalup WA 6027
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Country
89991
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Australia
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Phone
89991
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(61 8) 6304 3444
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Fax
89991
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Email
89991
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[email protected]
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Contact person for scientific queries
Name
89992
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Mrs Christelle Schofield
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Address
89992
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Edith Cowan University Exercise Medicine Research Institute
Joondalup Campus, Building 21, Level 2
270 Joondalup Dr, Joondalup WA 6027
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Country
89992
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Australia
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Phone
89992
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(61 8) 6304 3444
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Fax
89992
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Email
89992
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
It is currently not policy at the Edith Cowan University to make individual participant data publicly available.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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