Effect of physical exercise on treadmill in women with polycystic ovary syndrome
| ISRCTN | ISRCTN10416750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10416750 |
| Secondary identifying numbers | RBR/78qtwy |
- Submission date
- 24/07/2018
- Registration date
- 14/08/2018
- Last edited
- 06/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Polycystic ovary syndrome (PCOS) is a common condition that leads to hyperandrogenism (excess male sex hormones) and other hormone alterations, increased weight and waist-to-hip ratio (WHR), behavioural changes such as sexual dysfunction, anxiety and dperession, and a reduced quality of life. Physical exercise is one of the ways to reduce these effects of PCOS. However, there have been no studies that have evaluated the effects of exercise on sexual function in women with PCOS.
This study aims to look at the effects of continuous and intermittent aerobic exercise on hormones, metabolism, body measurements such as weight and WHR, sexual function, quality of life, depression and anxiety, and telomere length (part of human chromosomes, the length of which affect how we age) in women with PCOS.
Who can participate?
Women with PCOS aged 18-39 years old with a BMI of 18-39.9 kg/m² who do not participate in regular exercise
What does the study involve?
Participants will be randomised into 3 groups - CAT, IAT and control.
The CAT group will be asked to perform 40-60 minutes of continuous physical aerobic training on a treadmill 3 times per week for 16 weeks.
The IAT group will be asked to perform 40-60 minutes of intermittent physical aerobic training on a treadmill 3 times per week for 16 weeks.
The control group will not perform any exercise.
At the start of the study and after 16 weeks of training, all 3 groups will be assessed on their sexual function and depression/anxiety by questionnaire. Blood samples will be taken to assess metabolic, hormonal and genetic changes, and weight, height, WHR and BMI will be measured using standard techniques. Additionally, participants will undergo X-rays to determine body fat.
What are the possible benefits and risks of participating
The possible benefit of participating is that exercise may lead to improvements both physically and mentally. There is a possible minor risk of discomfort during blood collection or breathlessness during physical training.
Where is the study run from?
Ribeirão Preto Medical School, University of São Paulo, Brazil
When is the study starting and how long is it expected to run for?
July 2014 to October 2018
Who is funding the study?
State Research Support Foundation of São Paulo (FAPESP) (Brazil)
Who is the main contact?
Professor Rosana Maria dos Reis
romareis@fmrp.usp.br
Contact information
Scientific
Ribeirão Preto Medical School (FMRP), USP
Av. Bandeirantes, 3900, Monte Alegre
RIBEIRÃO PRETO
14049-900
Brazil
 ORCID ID |
0000-0001-8753-7975 |
|---|
Scientific
Ribeirão Preto Medical School (FMRP), USP
Av. Bandeirantes, 3900, Monte Alegre
Ribeirão Preto
14049-900
Brazil
| ORCID ID |
0000-0001-9631-4167 |
|---|
Scientific
Ribeirão Preto Medical School (FMRP), USP
Av. Bandeirantes, 3900, Monte Alegre
Ribeirão Preto
14049900
Brazil
| ORCID ID |
0000-0002-2860-846X |
|---|
Study information
| Study design | Interventional open three-arm randomized controlled parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Effect of continuous and intermittent aerobic physical training in women with polycystic ovary syndrome |
| Study acronym | Effect of physical exercise in women with polycystic ovary syndrome |
| Study objectives | Continuous and intermittent aerobic physical training improves anthropometric, endocrine, metabolic, and inflammatory parameters of body composition, telomere length, epigenetics, sexual function, quality of life, anxiety and depression and body image in women with polycystic ovary sundrome |
| Ethics approval(s) | Institutional Review Board of the University Hospital (UH), Ribeirao Preto Medical School, University of Sao Paulo, 26/08/2014, 9640/2014 |
| Health condition(s) or problem(s) studied | Polycystic ovary syndrome (PCOS) |
| Intervention | A randomisation stratified by BMI (<30 kg / m² and ≥ 30 kg / m²) was used using blocks of 15. Each block of 15 allocated 5 participants to Group I, 5 to Group II and 5 to Group III. The allocation group was placed into sequentially numbered sealed opaque envelopes that were grouped into blocks of 15. These blocks were picked up consecutively and separated depending on the participant's BMI at the time of inclusion. After the inclusion of the participant, the envelope was opened and the patient was allocated according to the contents of the envelope. 90 women with polycystic ovary syndrome (PCOS) will be placed randomly in three parallel groups. Participants in Group I will perform continuous aerobic physical training in a treadmill with 40-60 minutes of workout during 16 weeks, 3 times per week. Participants in Group II will perform intermittent aerobic exercise training in a treadmill with 40-60 minutes of workout during 16 weeks, 3 times per week. Participants in Group III will be the placebo group and therefore will not receive any intervention. The training protocol for the groups I and II will also have 5 minutes of heating and 5 minutes cool-down (50-60% of maximum heart rate). The intensity of the continuous aerobic physical training (Group I) and interval aerobic physical training (Group II) will be adjusted to provide the same volume of training for both groups. The intensity will be calculated using the formula 220 - age x % intensity, which is between 60 and 90%. Progressions of time as the intensity take place during the training, respecting the range of values mentioned above, as far as increased training volume. |
| Intervention type | Other |
| Primary outcome measure | Alterations in telomere content, analyzed by quantitative real time polymerase chain reaction (qPCR) at the baseline and after 16 weeks of physical training for all groups. The data are expressed in relative values of 2-CT in which it is expected a difference of 0.3 between the group. |
| Secondary outcome measures | Changes in the following were measured at the baseline and after 16 weeks of physical training for all groups: 1. Hormone concentrations and endocrine parameters, assessed by chemiluminescence 2. Body composition, assessed by absorptiometry method Dual Energy X-Ray absortiometry (DEXA), skin folds and bioelectrical impedance 3. Anthropometric indices 4. Epigenetic mechanisms, investigated by the Genome-Wide DNA methylation, X inactivation and the CAG repeat polymorphism within the androgen receptor gene 5. Quality of life, assessed using the Short Form 36 (SF-36) questionnaire 6. Anxiety and depression, assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire 7. Sexual function, assessed using the Female Sexual Function Index (FSFI) 8. Body image, assessed using the Body Shape Questionnaire (BSQ) and Figure Rating Scale (FRS) |
| Overall study start date | 10/07/2014 |
| Completion date | 20/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 39 Years |
| Sex | Female |
| Target number of participants | 90 (30 in each group) |
| Total final enrolment | 87 |
| Key inclusion criteria | 1. Polycystic ovary syndrome 2. Aged 18-39 years 3. BMI 18-39.9 kg/m² (normal, overweight and obesity grades I and II) 4. Do not practice regular physical activity |
| Key exclusion criteria | 1. Presence of systemic disease that contraindicate physical activity 2. Presence of disabling musculo-skeletal disorders 3. Use of drugs that interfere with the hypothalamic-pituitary-ovarian-axis 4. Use of hormonal contraceptives 5. Smoking 6. Pregnant 7. Not available to participate in all stages of the study |
| Date of first enrolment | 05/11/2014 |
| Date of final enrolment | 15/04/2017 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Ribeirão Preto-SP
CEP: 14049-900
Brazil
Sponsor information
Not defined
Av. Bandeirantes, 3900, Monte Alegre
Ribeirão Preto
14049900
Brazil
| Website | http://www.fmrp.usp.br/ |
|---|---|
"ROR" |
https://ror.org/00ey54k21 |
Funders
Funder type
Not defined
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 19/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to send for publication between 2018 and 2019 all the variables that are being evaluated in this study. |
| IPD sharing plan | The datasets analysed during the current study will be available upon request from romareis@fmrp.usp.br. The data can be made available with averages and standard deviations and final statistics after being published. In addition, the volunteers will not be identified, and the confidentiality of the information related to the participant's privacy will be maintained, as applied by the consent term of this study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/08/2020 | 19/08/2021 | Yes | No | |
| Results article | 27/10/2021 | 06/09/2023 | Yes | No |
Editorial Notes
06/09/2023: Publication reference added.
The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
