Polycystic Ovary SyndromeNCT05603169
High Intensity Resistance and Aerobic Training Among Women With PCOS
A study testing High intensity resistance Exercise Training and High intensity aerobic Exercise Training in people with Polycystic Ovary Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
polycystic ovarian syndrome (PCOS) is the most common endocrine female disorder, affecting 4-18% women of reproductive age. The prevalence of PCOS in South Asian women, especially in Pakistani women, is much higher (52%) as compared to white population (20 - 25% in UK). Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- High intensity resistance Exercise Training and High intensity aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women diagnosed with PCOS according to Rotterdam criteria
- Age limit: 18-30
- Women who are not part of planned physical activity for the last six months.
- BMI<=30
Who cannot join
- Women with PCOS who are already on birth control or hormone therapy.
- Women with PCOS who are already are taking some medication for psychological issues
- Women who are already taking cholesterol control medications.
- Women who are a part of any physical activity already
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Intensity Resistance and Aerobic Training Among Women With Polycystic Ovarian Syndrome.
polycystic ovarian syndrome (PCOS) is the most common endocrine female disorder, affecting 4-18% women of reproductive age. The prevalence of PCOS in South Asian women, especially in Pakistani women, is much higher (52%) as compared to white population (20 - 25% in UK). On the basis of cultural, environment, diet and lifestyle practices these women are more prone to development of such disorder. So such public health issue needs to be addressed by strong evidence conducted by a clinical trial. The current study is planned to compare effects of two different exercise protocols of high intensity on anthropometric measures, hormonal profile and quality of life.
Read the detailed description
PCOS is a prevalent condition that is affecting adolescent girls now and has serious impacts on menstrual health and quality of life making them prone to early risk development for chronic metabolic diseases. The comparison between high intensity resistance and aerobic training would give results that which one is more effective in gaining benefits and better effects on overall health both physically(menstrual) as well as mentally that would eventually tell us about the quality of life of such patients.
After the initial screening process, the participants fulfilling the Roterdam criteria, willing to participate in the exercise trial will be recruited and then randomized to the allocated groups of either high intensity resistance or high intensity aerobics. At baseline, their anthropometrics measurements, LH/FSH ratios and fasting plasma glucose test will be done. Patient will be called thrice a week for 3 months for training. It is hypothesized that high intensity resistance or high intensity aerobics will improve anthropometric measures along with hormonal profile and quality of life.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- High intensity resistance Exercise Training, High intensity aerobic Exercise Training
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity resistance Exercise TrainingOther
The resistance training will consist of five resistance exercises (thrice a week on non-consecutive days): squat, leg press, knee extension, lunges, and abdominal crunches. Every participant will be assessed pre and post intervention for hormonal change, BMI/anthropometric measures, fasting glucose and quality of life.The plan will be followed for 12 weeks
High intensity aerobic Exercise TrainingOther
The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Resistance Training | Active comparator | This group will perform high intensity resistance training under supervised physiotherapist in a gym setting. The training load for the first 2 weeks will be 60%-75% of 1RM and increased to 75%-90% of 1RM the following weeks. Load would be increased if the participants will be able to perform 3 sets of 12 repetitions with that load. Receives: Other: High intensity resistance Exercise Training |
| High Intensity Aerobic Training | Active comparator | This group will perform aerobic training under supervision of a physical therapist in gym setting. To calculate exercise intensity, the HR will be maintained at 75-90% of the maximum (HRmax). The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity Receives: Other: High intensity aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Measured: changes from Baseline to 4 weeks
Body Mass Index
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Measured: changes from 4 weeks to 8weeks
Body Mass Index
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Measured: changes from 8 weeks to 12 weeks
Waist Hip Ratio
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Measured: changes from Baseline to 4 weeks
Waist Hip Ratio
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Measured: changes from 4 weeks to 8weeks
Waist Hip Ratio
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Measured: changes from 8 weeks to 12 weeks
Polycystic ovarian syndrome questionnaire (PCOSQ)
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.
Measured: changes from Baseline to 6 weeks
Polycystic ovarian syndrome questionnaire (PCOSQ)
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.
Measured: changes from 6 weeks to 12 weeks
SF-36 QOL
The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
Measured: changes from Baseline to 6 weeks
SF-36 Quality of life
The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
Measured: changes from 6 weeks to 12 weeks
Secondary outcomes (1)
LH/FSH ratios
Luteinizing hormone (LH), follicle-stimulating hormone (FSH), and LH/FSH ratio will be measured when considering a PCOS diagnosis. The LH/FSH ratio is a valid and frequently employed method to test the ovulation and menstrual health of such women and have been reported by many studies
Measured: changes from Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Nov 2022
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment into two groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603169
- Sponsor's protocol ID
- RiphahIU Mobeena Maqsood
- Status last verified
- May 2023
- First submitted
- 28 Oct 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benham JL, Booth JE, Corenblum B, Doucette S, Friedenreich CM, Rabi DM, Sigal RJ. Exercise training and reproductive outcomes in women with polycystic ovary syndrome: A pilot randomized controlled trial. Clin Endocrinol (Oxf). 2021 Aug;95(2):332-343. doi: 10.1111/cen.14452. Epub 2021 May 3.
PubMed 33638879Shele G, Genkil J, Speelman D. A Systematic Review of the Effects of Exercise on Hormones in Women with Polycystic Ovary Syndrome. J Funct Morphol Kinesiol. 2020 May 31;5(2):35. doi: 10.3390/jfmk5020035.
PubMed 33467251Mario FM, Graff SK, Spritzer PM. Habitual physical activity is associated with improved anthropometric and androgenic profile in PCOS: a cross-sectional study. J Endocrinol Invest. 2017 Apr;40(4):377-384. doi: 10.1007/s40618-016-0570-1. Epub 2016 Oct 22.
PubMed 27771865Wright PJ, Corbett CF, Pinto BM, Dawson RM, Wirth M. Resistance Training as Therapeutic Management in Women with PCOS: What is the Evidence? Int J Exerc Sci. 2021 Aug 1;14(3):840-854. doi: 10.70252/NEEX8658. eCollection 2021.
PubMed 34567361Kogure GS, Miranda-Furtado CL, Pedroso DCC, Ribeiro VB, Eiras MC, Silva RC, Caetano LC, Ferriani RA, Calado RT, Dos Reis RM. Effects of Progressive Resistance Training on Obesity Indices in Polycystic Ovary Syndrome and the Relationship With Telomere Length. J Phys Act Health. 2019 Aug 1;16(8):601-607. doi: 10.1123/jpah.2018-0256.
PubMed 31319405Mitrašinović-Brulić M, Buljan M, Suljević D. Association of LH/FSH ratio with menstrual cycle regularity and clinical features of patients with polycystic ovary syndrome. Middle East Fertility Society Journal. 2021;26(1):40.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Resistance and Aerobic Training Among Women With Polycystic Ovarian Syndrome.
- ClinicalTrials.gov ID
- NCT05603169
- Acronym / sponsor ID
- RiphahIU Mobeena Maqsood
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
polycystic ovarian syndrome (PCOS) is the most common endocrine female disorder, affecting 4-18% women of reproductive age. The prevalence of PCOS in South Asian women, especially in Pakistani women, is much higher (52%) as compared to white population (20 - 25% in UK). On the basis of cultural, environment, diet and lifestyle practices these women are more prone to development of such disorder. So such public health issue needs to be addressed by strong evidence conducted by a clinical trial. The current study is planned to compare effects of two different exercise protocols of high intensity on anthropometric measures, hormonal profile and quality of life.
Detailed description
PCOS is a prevalent condition that is affecting adolescent girls now and has serious impacts on menstrual health and quality of life making them prone to early risk development for chronic metabolic diseases. The comparison between high intensity resistance and aerobic training would give results that which one is more effective in gaining benefits and better effects on overall health both physically(menstrual) as well as mentally that would eventually tell us about the quality of life of such patients.
After the initial screening process, the participants fulfilling the Roterdam criteria, willing to participate in the exercise trial will be recruited and then randomized to the allocated groups of either high intensity resistance or high intensity aerobics. At baseline, their anthropometrics measurements, LH/FSH ratios and fasting plasma glucose test will be done. Patient will be called thrice a week for 3 months for training. It is hypothesized that high intensity resistance or high intensity aerobics will improve anthropometric measures along with hormonal profile and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment into two groups
| Arm | Type | Receives |
|---|---|---|
| High Intensity Resistance Training | Active comparator | Other: High intensity resistance Exercise TrainingThis group will perform high intensity resistance training under supervised physiotherapist in a gym setting. The training load for the first 2 weeks will be 60%-75% of 1RM and increased to 75%-90% of 1RM the following weeks. Load would be increased if the participants will be able to perform 3 sets of 12 repetitions with that load. |
| High Intensity Aerobic Training | Active comparator | Other: High intensity aerobic Exercise TrainingThis group will perform aerobic training under supervision of a physical therapist in gym setting. To calculate exercise intensity, the HR will be maintained at 75-90% of the maximum (HRmax). The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women diagnosed with PCOS according to Rotterdam criteria
- Age limit: 18-30
- Women who are not part of planned physical activity for the last six months.
- BMI<=30
Key exclusion criteria (4 listed)
- Women with PCOS who are already on birth control or hormone therapy.
- Women with PCOS who are already are taking some medication for psychological issues
- Women who are already taking cholesterol control medications.
- Women who are a part of any physical activity already
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity resistance Exercise TrainingThe resistance training will consist of five resistance exercises (thrice a week on non-consecutive days): squat, leg press, knee extension, lunges, and abdominal crunches. Every participant will be assessed pre and post intervention for hormonal change, BMI/anthropometric measures, fasting glucose and quality of life.The plan will be followed for 12 weeks | Other | High Intensity Resistance Training |
| High intensity aerobic Exercise TrainingThe training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity | Other | High Intensity Aerobic Training |
Primary outcome
Body Mass Index
Time frame: changes from Baseline to 4 weeks
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Body Mass Index
Time frame: changes from 4 weeks to 8weeks
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Body Mass Index
Time frame: changes from 8 weeks to 12 weeks
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Waist Hip Ratio
Time frame: changes from Baseline to 4 weeks
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Waist Hip Ratio
Time frame: changes from 4 weeks to 8weeks
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Waist Hip Ratio
Time frame: changes from 8 weeks to 12 weeks
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Polycystic ovarian syndrome questionnaire (PCOSQ)
Time frame: changes from Baseline to 6 weeks
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.
Polycystic ovarian syndrome questionnaire (PCOSQ)
Time frame: changes from 6 weeks to 12 weeks
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.
SF-36 QOL
Time frame: changes from Baseline to 6 weeks
The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
SF-36 Quality of life
Time frame: changes from 6 weeks to 12 weeks
The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
1 secondary outcome
LH/FSH ratios
Time frame: changes from Baseline to 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 33638879Benham JL, Booth JE, Corenblum B, Doucette S, Friedenreich CM, Rabi DM, Sigal RJ. Exercise training and reproductive outcomes in women with polycystic ovary syndrome: A pilot randomized controlled trial. Clin Endocrinol (Oxf). 2021 Aug;95(2):332-343. doi: 10.1111/cen.14452. Epub 2021 May 3.
- Background: PubMed 33467251Shele G, Genkil J, Speelman D. A Systematic Review of the Effects of Exercise on Hormones in Women with Polycystic Ovary Syndrome. J Funct Morphol Kinesiol. 2020 May 31;5(2):35. doi: 10.3390/jfmk5020035.
- Background: PubMed 27771865Mario FM, Graff SK, Spritzer PM. Habitual physical activity is associated with improved anthropometric and androgenic profile in PCOS: a cross-sectional study. J Endocrinol Invest. 2017 Apr;40(4):377-384. doi: 10.1007/s40618-016-0570-1. Epub 2016 Oct 22.
- Background: PubMed 34567361Wright PJ, Corbett CF, Pinto BM, Dawson RM, Wirth M. Resistance Training as Therapeutic Management in Women with PCOS: What is the Evidence? Int J Exerc Sci. 2021 Aug 1;14(3):840-854. doi: 10.70252/NEEX8658. eCollection 2021.
- Background: PubMed 31319405Kogure GS, Miranda-Furtado CL, Pedroso DCC, Ribeiro VB, Eiras MC, Silva RC, Caetano LC, Ferriani RA, Calado RT, Dos Reis RM. Effects of Progressive Resistance Training on Obesity Indices in Polycystic Ovary Syndrome and the Relationship With Telomere Length. J Phys Act Health. 2019 Aug 1;16(8):601-607. doi: 10.1123/jpah.2018-0256.
- BackgroundMitrašinović-Brulić M, Buljan M, Suljević D. Association of LH/FSH ratio with menstrual cycle regularity and clinical features of patients with polycystic ovary syndrome. Middle East Fertility Society Journal. 2021;26(1):40.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Riaz principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity resistance Exercise Training and High intensity aerobic Exercise Training in people with Polycystic Ovary Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: changes from Baseline to 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603169, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.