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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
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
Secondary ID [1] 297081 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian cancer 311620 0
Condition category
Condition code
Cancer 309721 309721 0 0
Ovarian and primary peritoneal
Physical Medicine / Rehabilitation 310244 310244 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313356 0
Treatment: Other
Intervention code [2] 313357 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 318688 0
Muscle mass as assessed with dual-energy x-ray absorptiometry (DEXA) and peripheral quantitative computed tomography (pQCT) scans
Timepoint [1] 318688 0
Baseline and one to two weeks after completion of 12-week intervention (primary timepoint)
Primary outcome [2] 318689 0
Muscle density as assessed with peripheral quantitative computed tomography (pQCT) scans
Timepoint [2] 318689 0
Baseline and one to two weeks after completion of 12-week intervention (primary timepoint)
Secondary outcome [1] 365734 0
Mobility as assessed as a composite of the 400 m corridor walk and 6 m usual pace walk
Timepoint [1] 365734 0
Baseline and one to two weeks after completion of 12-week intervention
Secondary outcome [2] 365735 0
Mobility and dynamic balance as assessed with a Timed Up and Go (TUG) test
Timepoint [2] 365735 0
Baseline and one to two weeks after completion of 12-week intervention
Secondary outcome [3] 365736 0
Upper body muscular strength as assessed with a one-repetition maximum (1-RM) chest press
Timepoint [3] 365736 0
Baseline and one to two weeks after completion of 12-week intervention
Secondary outcome [4] 365737 0
Lower body muscular strength as assessed with a 5-RM leg press
Timepoint [4] 365737 0
Baseline and one to two weeks after completion of 12-week intervention
Secondary outcome [5] 367134 0
Handgrip strength as assessed with a handgrip strength test done with a handgrip dynamometer
Timepoint [5] 367134 0
Baseline and one to two weeks after completion of 12-week intervention
Secondary outcome [6] 367135 0
Objective activity behaviors (objective physical activity and sedentary time) as assessed with accelerometers - composite secondary outcome
Timepoint [6] 367135 0
Baseline and one to two weeks after completion of 12-week intervention
Secondary outcome [7] 367136 0
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)
Timepoint [7] 367136 0
Baseline and one to two weeks after completion of 12-week intervention
Secondary outcome [8] 367137 0
Self-reported pelvic floor function as assessed with the Australian Pelvic Floor Questionnaire
Timepoint [8] 367137 0
Baseline and one to two weeks after completion of 12-week intervention

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed as central randomisation will be done by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2020
Actual
Date of last participant enrolment
Anticipated
15/01/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
40
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12921 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [2] 12922 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 25396 0
6008 - Subiaco
Recruitment postcode(s) [2] 25397 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 301649 0
University
Name [1] 301649 0
Edith Cowan University
Country [1] 301649 0
Australia
Funding source category [2] 301975 0
Charities/Societies/Foundations
Name [2] 301975 0
Cancer Council Western Australia (WA)
Country [2] 301975 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 301360 0
Hospital
Name [1] 301360 0
St John of God Subiaco Hospital
Address [1] 301360 0
12 Salvado Rd, Subiaco WA 6008
Country [1] 301360 0
Australia
Secondary sponsor category [2] 301695 0
Hospital
Name [2] 301695 0
Sir Charles Gairdner Hospital
Address [2] 301695 0
Hospital Ave, Nedlands WA 6009
Country [2] 301695 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302370 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 302370 0
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
ethics@sjog.org.au
Ethics committee country [1] 302370 0
Australia
Date submitted for ethics approval [1] 302370 0
05/03/2019
Approval date [1] 302370 0
12/04/2019
Ethics approval number [1] 302370 0
Ethics committee name [2] 302629 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [2] 302629 0
Sir Charles Gairdner Hospital
2nd Floor, A Block (Mailbox 26)
Hospital Ave, Nedlands WA 6009
HREC.SCGH@health.wa.gov.au
Ethics committee country [2] 302629 0
Australia
Date submitted for ethics approval [2] 302629 0
26/03/2019
Approval date [2] 302629 0
28/11/2019
Ethics approval number [2] 302629 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89990 0
Mrs Christelle Schofield
Address 89990 0
Edith Cowan University Exercise Medicine Research Institute
Joondalup Campus, Building 21, Level 2
270 Joondalup Dr, Joondalup WA 6027
Country 89990 0
Australia
Phone 89990 0
(61 8) 6304 3444
Fax 89990 0
Email 89990 0
cschofie@our.ecu.edu.au
Contact person for public queries
Name 89991 0
Mrs Christelle Schofield
Address 89991 0
Edith Cowan University Exercise Medicine Research Institute
Joondalup Campus, Building 21, Level 2
270 Joondalup Dr, Joondalup WA 6027
Country 89991 0
Australia
Phone 89991 0
(61 8) 6304 3444
Fax 89991 0
Email 89991 0
cschofie@our.ecu.edu.au
Contact person for scientific queries
Name 89992 0
Mrs Christelle Schofield
Address 89992 0
Edith Cowan University Exercise Medicine Research Institute
Joondalup Campus, Building 21, Level 2
270 Joondalup Dr, Joondalup WA 6027
Country 89992 0
Australia
Phone 89992 0
(61 8) 6304 3444
Fax 89992 0
Email 89992 0
cschofie@our.ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is currently not policy at the Edith Cowan University to make individual participant data publicly available.


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.