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Trial registered on ANZCTR


Registration number
ACTRN12614000517673
Ethics application status
Approved
Date submitted
7/05/2014
Date registered
15/05/2014
Date last updated
15/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of progressive resistance training in women with polycystic ovary syndrome. A feasibility study
Scientific title
A randomised control trial comparing the benefits of progressive resistance training and/or usual care on health status in women with polycystic ovary syndrome
Secondary ID [1] 284560 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
PCOSPRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polycystic ovary syndrome

291827 0
insulin resistance 291854 0
obesity 291855 0
menstrual disturbance 291856 0
depression 291857 0
anxiety 291858 0
Polycystic Ovary Syndrome health related quality of life 291859 0
exercise self efficacy 291860 0
health related quality of life 291861 0
perceived stress scale 291862 0
Condition category
Condition code
Metabolic and Endocrine 292192 292192 0 0
Other metabolic disorders
Reproductive Health and Childbirth 292193 292193 0 0
Other reproductive health and childbirth disorders
Mental Health 292194 292194 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women will be randomised into either the progressive resistance training group or usual care group. The trial will run for 12 weeks. Both groups will need to attend two baseline and two follow up session for 1-2 hours. Both groups will be assessed weekly to document for adverse changes or events
Exercise intervention
PRT- Participants randomised to the progressive resistance training (PRT) will be required to undertake every week for 12 weeks: two supervised exercise sessions on non consecutive days for 1 hour at the University of Western Sydney Campbelltown or Penrith campus as well as perform two unsupervised sessions for 30 minutes at home. The exercises will consist of muscles involving the arms, back, legs and core. the basis of the intervention is to train to neuromuscular fatigue (for instance training at an RM of 8-12 repetitions. for the supervised sessions, exercises will consist of mainly machines and free weight activities. for the first two weeks each exercise will be performed at 2 sets of 8-12 RM. on the third week most exercises will be progressed to 3 sets of 8-12 RM until study completion. Exercise sessions will be progressed and adjusted to account for individuals exercise capacity and training adaptations.
The home based exercises will consist of six different body callisthenics (such as body weight exercises) without the use of machines/free weights and each exercise will be performed with 3 sets of 10 repetitions. the home based exercises will be modified every four weeks to different and challenging exercises. adherence for the home based sessions will be measured via determine the number of sessions done for both supervised and unsupervised (home based). Participants are required to maintain a diary to record the number of sessions done for the home based sessions.
Intervention code [1] 289329 0
Lifestyle
Intervention code [2] 289330 0
Behaviour
Comparator / control treatment
Usual care group- participants randomised to the usual care group will be required to continue with their usual care (from physicians, practitioners etc). Upon completion participants will be evaluated and will be provided with an exercise program to incorporate as part of their lifestyle program
Control group
Active

Outcomes
Primary outcome [1] 292065 0
Primary outcome: Feasibility of prescribing PRT. This will be done by evaluating:
* recruitment strategies and rate
* adherence and compliance rates
* retention rates for PRT and usual care
* suitability of outcome measures
Timepoint [1] 292065 0
February to November, Before and 12 weeks
Secondary outcome [1] 308116 0
Secondary outcome: menstrual regularity via self-care diaries
Timepoint [1] 308116 0
before and after 12 weeks
Secondary outcome [2] 308117 0
Body composition changes by DEXA scans, waist circumference, hip circumference
Timepoint [2] 308117 0
before and after 12 weeks
Secondary outcome [3] 308118 0
haematological outcomes (i.e. insulin, glucose, SHBG, FAI, Testosterone, Hs-CRP, HbA1c)
Timepoint [3] 308118 0
before and after 12 weeks
Secondary outcome [4] 308119 0
Maximal isometric voluntary contractions for the upper and lower body - using an isokinetic machine such as the biodex.
Timepoint [4] 308119 0
before and after 12 weeks
Secondary outcome [5] 308120 0
psychological status: using validated questionnaires which include:
* Polycystic ovary syndrome quality of life
* Short-form 36
* Depression Anxiety stress scale
* Exercise self efficacy
* Perceived stress scale
Timepoint [5] 308120 0
before and after 12 weeks

Eligibility
Key inclusion criteria
Must be diagnosed with polycystic ovary syndrome by Rotterdam Criteria, which includes two of the following: (i) irregular menstrual cycles (<21 or >35 days), (ii) clinical (hirsutism, acne) or biochemical (elevation of at least one circulating ovarian androgen) and (iii) polycystic ovaries on untrasound along with the exclusion of other etiologies such as cushings syndrome, congenital adrenal hyperplasia and androgen secreting tumours. Must have BMI > 25 m/kg2 and not on any fertility treatments. Not currently engaged in a high training resistance program, willingness to be randomised and to undergo study protocols
Minimum age
18 Years
Maximum age
42 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Not pregnant or breastfeeding, no use of cigarettes greater than 6 months, no history of cardiovascular, liver, kidney, respiratory disease, uncontrolled hypertension or cancer, no acute or chronic medical conditions that would make assessment and interventions potentially hazardous or impossible to assess.

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)
Participants will be recruited by means of flyer advertisement posted on bulletin boards, and delivered by online social media (e.g Facebook), mail drops and newspaper. Participants will also be recruited via direct referral by local physicians and clinicians. All potential participants will be pre-screened via telephone or in-person, according to individual preference, for medical and study eligibility using a standardised eligibility checklist, detailed medical history questionnaire, and Physical Activity Readiness Questionnaire (PAR-Q). Participants will be required to attend a baseline testing session for 1-2 hours for the assessment of body composition, isometric strength, menstrual cyclicity and psychological status. Upon completion of baseline testing participants will be given a sealed envelope detailing the allocation to either the PRT or usual care group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation procedures used will be a simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). This will be done by an investigator not involved in testing or training
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Secondary analysis will be analysed via intention-to-treat with all patients included regardless of dropout or level of adherence. Missing data will be imputed according to the maximum likelihood expectation algorithm via the Statistical Package for the Social Sciences (SPSS Version 20.0). Data will be presented as the mean or median, with ranges, SD, and confidence intervals to express group differences as appropriate. Baseline characteristics will be compared using t-tests and Mann-Whitney U-tests for continuous parametric and non-parametric variables, respectively. Chi square tests will be used for all non-continuous, descriptive variables. Changes over time (group x time) in all continuous outcome variables and covariates will be determined by repeated measures analysis of variance (ANOVA) in unadjusted models, and analysis of covariance (ANCOVA) when appropriate. Effect sizes and 95% confidence intervals will be calculated. Categorical variables will be analyzed using logistic regression models. Linear and multivariate regression analyses will be used to analyze associations between variables of interest. A p value of <0.05 will be considered indicative of statistical significance; clinical significance will be interpreted in light of the meaningfulness and magnitude of the adaptations observed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289186 0
University
Name [1] 289186 0
University of Western Sydney
Address [1] 289186 0
School of Science and Health
University of Western Sydney
Locked Bag 1797
Penrith South NSW 2751
Country [1] 289186 0
Australia
Primary sponsor type
Individual
Name
Miss Lisa Vizza
Address
School of Science and Health
University of Western Sydney
Locked Bag 1797
Penrith South NSW 2751
Country
Australia
Secondary sponsor category [1] 287857 0
University
Name [1] 287857 0
University of Western Sydney
Address [1] 287857 0
School of Science and Health
Locked Bag 1797
Penrith South NSW 2751
Country [1] 287857 0
Australia
Secondary sponsor category [2] 287906 0
Commercial sector/Industry
Name [2] 287906 0
Douglas Hanly Moir
Address [2] 287906 0
14 Giffnock Avenue
Macquarie Park NSW
2113
Country [2] 287906 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290965 0
Human research Ethics committee
Ethics committee address [1] 290965 0
Locked bag 1797 Penrith NSW 2751 Australia
Ethics committee country [1] 290965 0
Australia
Date submitted for ethics approval [1] 290965 0
Approval date [1] 290965 0
03/12/2013
Ethics approval number [1] 290965 0
H10448

Summary
Brief summary
The purpose of this study is to investigate the feasibility of a 12 week progressive resistance training program versus usual care in overweight women with polycystic ovary syndrome. Participants will be required to attend two baseline and two follow up session for 1-2 hours at the University of Western Sydney Campbelltown for the assessment of body composition, isometric strength, menstrual cycle and psychological status. On separate days participants will also be asked to undertake fasting blood samples first thing in the morning at Douglas Hanly Moir pathology. Upon completion of baseline testing participants will be randomised to either the PRT or usual care group and will be given to participants in a sealed envelope. Participants randomised to the PRT group will be required to exercise four sessions per week, where two sessions will be supervised at the University Western Sydney Campbelltown campus while the other two sessions will be unsupervised (i.e. home based). . If you are allocated to the usual care group, you will be required to continue with your usual care management for the duration of the trial. The researcher will contact you weekly to document for any adverse events or reactions. Participants will also be required to maintain a diary to record their menstrual cycle details such as cycle length (i.e. day one of period and day one of next period), signs and symptoms etc.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48178 0
Miss Lisa Vizza
Address 48178 0
School of Science and Health
University of Western Sydney Locked Bag 1797 Penrith South NSW 2751
Country 48178 0
Australia
Phone 48178 0
+61 2 4620 3397
Fax 48178 0
+61 2 4620 3792
Email 48178 0
16310852@student.uws.edu.au
Contact person for public queries
Name 48179 0
Miss Lisa Vizza
Address 48179 0
School of Science and Health
University of Western Sydney Locked Bag 1797 Penrith South NSW 2751
Country 48179 0
Australia
Phone 48179 0
+61 2 4620 3397
Fax 48179 0
+61 2 4620 3792
Email 48179 0
16310852@student.uws.edu.au
Contact person for scientific queries
Name 48180 0
Miss Lisa Vizza
Address 48180 0
School of Science and Health
University of Western Sydney Locked Bag 1797 Penrith South NSW 2751
Country 48180 0
Australia
Phone 48180 0
+61 2 4620 3397
Fax 48180 0
+61 2 4620 3792
Email 48180 0
16310852@student.uws.edu.au

No information has been provided regarding IPD availability
Summary results
No Results