Polycystic Ovary SyndromeNCT05577949
Effect of Aerobics on Physical and Mental Health in Polycystic Ovary Syndrome
A study testing Structured aerobics exercise in people with Polycystic Ovary Syndrome, run by Muhammad Irfan at 4 sites in Pakistan.
Trial summary
Polycystic ovary is one of the most common metabolic and endocrine disorders in women of reproductive age group. The Rotterdam criteria are used internationally for its diagnosis. It has been reported that 57% of these women have at least one mental disorder. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Structured aerobics exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 4 sitesPakistan
- Study dates
- 1 Sep 2022to 30 Apr 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women diagnosed with PCOS according to the Rotterdam criteria with the age range of 18-49 years
Who cannot join
- Women that do not own personal smartphones
- Patients with endocrinological diseases like diabetes mellitus
- Thyroid, adrenal, or pituitary dysfunction
- Hepatic and pulmonary diseases
- Orthopedic
- Other diseases which can limit their physical activity or make it hazardous for them
- Participants with significant cognitive impairment, like intellectual disability or dementia, or active psychosis.
Trial locations and contacts
4 sites in 1 country.
Mifrah R Sethi, MSc, Mphil contact
Pakistan4 sites, 4 recruiting
- Recruiting
Hayatabad Medical Complex
Peshawar, Khyber Pakhtunkhwa
Rukhsana Karim, MBBS,FCPS
- Recruiting
Khyber teaching hospital
Peshawar, Khyber Pakhtunkhwa
Mahjabina S Ghayur, MBBS, FCPS
- Recruiting
Northwest teaching hospital and research centre
Peshawar, Khyber Pakhtunkhwa
Sumaira Inayat, MBBS,FCPS
- Recruiting
Mercy teaching hospital
Peshawar, Khyber Pukhtunkhwa
Samdana Wahab, MBBS,FCPS
About this study
Official title: The Effect of Structured Aerobics Exercise Programme for the Improvement of Mental and Physical Health Parameters in Patients With Polycystic Ovary Syndrome: A Randomised Controlled Trial
Polycystic ovary is one of the most common metabolic and endocrine disorders in women of reproductive age group. The Rotterdam criteria are used internationally for its diagnosis. It has been reported that 57% of these women have at least one mental disorder. There is no health without mental health and it is fundamental to the good health and well-being of an individual. Women with PCOS are at risk of a wide range of significant psychological difficulties including depression, anxiety, eating disorders, sexual disorders, low self-esteem, poor body image, and overall low quality of life. In the healthy population, exercise plays a pivotal role in the optimization of mental health, but there is little evidence available to demonstrate its effects on women with PCOS. So, this study has been designed to study the effects of structured aerobics exercise programs on the mental and physical health of women with PCOS.
Read the detailed description
Polycystic ovary syndrome is also referred to as "Hyperandrogenic anovulation or Stein Levinthal Syndrome". It has affected approximately 10 % of women of childbearing age. The prevalence of PCOS is higher among Pakistani women i.e. 52% as compared to the UK. The Rotterdam criteria are internationally used for the diagnosis of PCOS, which requires two out of the three features: signs of hyperandrogenism, ovulatory dysfunction, and ultrasound features of PCOS.
Although physical symptoms are increasingly recognized in women with PCOS, little attention has been paid to the mental health and well-being of these patients. PCOS creates an important psychological burden throughout the lifetime of these women. 57% of women with polycystic ovary syndrome have at least one mental disorder. Also, mental health is an essential part of public health and it is one of the most important indicators of the quality of health care in society.
Women with PCOS are at risk of a wide range of significant psychological difficulties including depression, anxiety, eating disorders, sexual disorders, low self-esteem, poor body image, and overall a lowered quality of life. In a healthy population, lifestyle modifications, particularly physical activity, and exercise play a pivotal role in the optimization of mental health but there is little evidence available to demonstrate the effects of exercise on the optimization of psychological well-being and physical health of women with PCOS. So, this study has been designed to study the effect of a structured aerobics exercise program on the mental and physical health of women with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Structured aerobics exercise
- Keywords
- Structured aerobics exercise program, Physical health, Mental health
- Medical subject headings
- Polycystic Ovary Syndrome, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured aerobics exerciseOther
A 12 week structured aerobics exercise program will be offered. The patient has to perform exercise five times a week , 30 minutes a day
| Study group | Role | What they receive |
|---|---|---|
| Aerobics | Experimental | This group will perform structured aerobics exercise program in addition to the standard treatment given for women with PCOS. Receives: Other: Structured aerobics exercise |
| Management used as "Treatment As Usual" | No intervention | This group will receive the standard management given for women with PCOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCOS Quality of Life scale
Change in the score of the PCO quality of life scale from baseline to midway to end of therapy, higher scores mean a better quality of life.
Measured: 12 weeks (3 months)
Hospital Anxiety and Depression Scale
Change in the score of the Hospital anxiety and depression scale from baseline to midway to end of therapy, 0-7 indicates normal, 8 to 10 indicates borderline and 11-21 indicates abnormal cases. Higher scores mean a worse outcome
Measured: 12 weeks (3 months)
Secondary outcomes (1)
ENRICH marital satisfaction scale
Change in the score of the ENRICH marital satisfaction scale from baseline to midway to end of therapy, higher scores mean better marital satisfaction.
Measured: 12 weeks (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Sep 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Irfan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Irfan, Peshawar Medical College
- Investigators
- Rabia Kareem, MBBS,FCPS, Principal investigator, Peshawar Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577949
- Sponsor's protocol ID
- Aerobics & PCOs
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Structured Aerobics Exercise Programme for the Improvement of Mental and Physical Health Parameters in Patients With Polycystic Ovary Syndrome: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05577949
- Acronym / sponsor ID
- Aerobics & PCOs
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Structured aerobics exercise program, Physical health, Mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Muhammad IrfanUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 13 Oct 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 ovary is one of the most common metabolic and endocrine disorders in women of reproductive age group. The Rotterdam criteria are used internationally for its diagnosis. It has been reported that 57% of these women have at least one mental disorder. There is no health without mental health and it is fundamental to the good health and well-being of an individual. Women with PCOS are at risk of a wide range of significant psychological difficulties including depression, anxiety, eating disorders, sexual disorders, low self-esteem, poor body image, and overall low quality of life. In the healthy population, exercise plays a pivotal role in the optimization of mental health, but there is little evidence available to demonstrate its effects on women with PCOS. So, this study has been designed to study the effects of structured aerobics exercise programs on the mental and physical health of women with PCOS.
Detailed description
Polycystic ovary syndrome is also referred to as "Hyperandrogenic anovulation or Stein Levinthal Syndrome". It has affected approximately 10 % of women of childbearing age. The prevalence of PCOS is higher among Pakistani women i.e. 52% as compared to the UK. The Rotterdam criteria are internationally used for the diagnosis of PCOS, which requires two out of the three features: signs of hyperandrogenism, ovulatory dysfunction, and ultrasound features of PCOS.
Although physical symptoms are increasingly recognized in women with PCOS, little attention has been paid to the mental health and well-being of these patients. PCOS creates an important psychological burden throughout the lifetime of these women. 57% of women with polycystic ovary syndrome have at least one mental disorder. Also, mental health is an essential part of public health and it is one of the most important indicators of the quality of health care in society.
Women with PCOS are at risk of a wide range of significant psychological difficulties including depression, anxiety, eating disorders, sexual disorders, low self-esteem, poor body image, and overall a lowered quality of life. In a healthy population, lifestyle modifications, particularly physical activity, and exercise play a pivotal role in the optimization of mental health but there is little evidence available to demonstrate the effects of exercise on the optimization of psychological well-being and physical health of women with PCOS. So, this study has been designed to study the effect of a structured aerobics exercise program on the mental and physical health of women with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobics | Experimental | Other: Structured aerobics exerciseThis group will perform structured aerobics exercise program in addition to the standard treatment given for women with PCOS. |
| Management used as "Treatment As Usual" | No intervention | –This group will receive the standard management given for women with PCOS |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women diagnosed with PCOS according to the Rotterdam criteria with the age range of 18-49 years
Key exclusion criteria (7 listed)
- Women that do not own personal smartphones
- Patients with endocrinological diseases like diabetes mellitus
- Thyroid, adrenal, or pituitary dysfunction
- Hepatic and pulmonary diseases
- Orthopedic
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 |
|---|---|---|
| Structured aerobics exerciseA 12 week structured aerobics exercise program will be offered. The patient has to perform exercise five times a week , 30 minutes a day | Other | Aerobics |
Primary outcome
PCOS Quality of Life scale
Time frame: 12 weeks (3 months)
Change in the score of the PCO quality of life scale from baseline to midway to end of therapy, higher scores mean a better quality of life.
Hospital Anxiety and Depression Scale
Time frame: 12 weeks (3 months)
Change in the score of the Hospital anxiety and depression scale from baseline to midway to end of therapy, 0-7 indicates normal, 8 to 10 indicates borderline and 11-21 indicates abnormal cases. Higher scores mean a worse outcome
1 secondary outcome
ENRICH marital satisfaction scale
Time frame: 12 weeks (3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- 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.
Mifrah R Sethi, MSc, Mphil contact
Rabia Kareem, MBBS,FCPS principal investigator
Peshawar Medical College
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured aerobics exercise in people with Polycystic Ovary Syndrome, run by Muhammad Irfan at 4 sites 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Irfan, FCPS,MS,PhD (+923339123625, mirfan78@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCOS Quality of Life scale (time frame: 12 weeks (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.