The role of exercise in treatment of women with Polycystic Ovary Syndrome (PCOS): mechanisms of action
| ISRCTN | ISRCTN84763265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84763265 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/12/2008
- Registration date
- 23/01/2009
- Last edited
- 28/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Helena Teede
Scientific
Scientific
SHPM, Monash Institute of Health Services Research
Monash Medical Centre
246 Clayton Road
Clayton
Melbourne
3168
Australia
| Phone | +61 (0)3 9594 7545 |
|---|---|
| helena.teede@med.monash.edu.au |
Study information
| Study design | Prospective cohort non-randomised un-blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | A prospective cohort study examining the effect of 12 weeks of intensive endurance exercise on insulin sensitivity and muscle insulin signalling in overweight women with or without polycystic ovary syndrome (PCOS) |
| Study acronym | PCOS |
| Study objectives | Women with polycystic ovary syndrome (PCOS) have both intrinsic insulin resistance and extrinsic obesity-related insulin resistance mediated via different mechanisms. Exercise is an effective intervention decreasing central adiposity reducing extrinsic insulin resistance and improving symptoms. |
| Ethics approval(s) | Received from the Southern Health Human Ethics Committee in March 2005 |
| Health condition(s) or problem(s) studied | Polycystic ovary syndrome |
| Intervention | Both PCOS and non-PCOS women underwent the same study protocol. From baseline, participants in the two groups undertook a 12 week programme of supervised intensified endurance exercise (1 hr/day; 3 x per week). Two different exercise sessions alternated, performing 1 hour of moderate intensity treadmill walking to elicit work rates of 70% of maximal oxygen consumption (VO2max) or 75 - 85% of maximal heart rate (HRmax). These were adjusted as fitness improved. Alternate sessions involve high intensity exercise with intermittent walking up an incline with 6 - 8 repetitions (5 minutes walking, 2 minutes recoveries) targeting 90 - 100% VO2max or 95 - 100% HRmax. Participants progress to 8 repetitions by the 4th week, with 1 minute of recovery. After 12 weeks of exercise all baseline measurements were repeated. |
| Intervention type | Other |
| Primary outcome measure | Effects on insulin resistance, measured at baseline and after 12 weeks of exercise. |
| Secondary outcome measures | 1. Clinical symptom improvement 2. Insulin signalling 3. Mitochondrial function Measured at baseline and after 12 weeks of exercise. |
| Overall study start date | 01/03/2005 |
| Completion date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Overweight women (body mass index [BMI] greater than 27 kg/m^2) 2. Aged 18 - 40 years with PCOS and without 3. Diagnosed from a history of perimenarchal onset of irregular cycles (less than 21 days or greater than 35 days) 4. Clinical manifestations of hyperandrogenism (hirsutism, acne) or biochemical hyperandrogenism with elevation of at least one circulating ovarian androgen (1990 National Institute of Health [NIH] criteria) |
| Key exclusion criteria | 1. BMI less than 27 kg/m^2 2. Other concurrent medical conditions 3. Ongoing use of the oral contraceptive pill (OCP) 4. Pregnancy or desire for pregnancy 5. Secondary causes of amenorrhoea and hyperandrogenism |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 01/03/2008 |
Locations
Countries of recruitment
- Australia
Study participating centre
SHPM, Monash Institute of Health Services Research
Melbourne
3168
Australia
3168
Australia
Sponsor information
Southern Health (Australia)
Government
Government
246 Clayton Road
Clayton
Melbourne
3168
Australia
| Phone | +61 (0)3 9594 6666 |
|---|---|
| malar.thiagarajan@southernhealth.org.au | |
| Website | http://www.southernhealth.org.au |
Funders
Funder type
University/education
Monash University (Australia) - New Investigator Award 2005
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | Yes | No |
