Polycystic Ovary SyndromeNCT02608554
Taichi for Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)
A study testing Taichi and Self-monitored exercise in people with Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 1 site in China.
Trial summary
The present study is a randomized pilot study, overweight/obese adolescent and young PCOS subjects will be assigned into two groups: Taichi arm and control arm. Hormonal profile and metabolic profile will be determined. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Taichi and Self-monitored exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to 31 Mar 2020
- 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 19 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 19 and 35 years;
- Diagnosis of PCOS according to the modified Rotterdam criteria;
- 2 years after menarche;
- Body mass index (BMI) equal to or greater than 23 kg/m*m.
Who cannot join
- Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
- Patients with other endocrine disorder including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
- Patients with known severe organ dysfunction or mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040
About this study
Official title: Taichi for Treating Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)
The present study is a randomized pilot study, overweight/obese adolescent and young PCOS subjects will be assigned into two groups: Taichi arm and control arm. Hormonal profile and metabolic profile will be determined.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Taichi, Self-monitored exercise
- Keywords
- Polycystic ovary sybdrome, Taichi
- 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.
TaichiBehavioural
The program of Taichi training consisted of 60 minutes exercise sessions, 3 days per week for 12 weeks, based on their original level of physical activity. Each session comprised 40 minutes of Taichi training plus a 10-minute warm-up and cool-down. The Taichi training was instructed by the same experienced Taichi instructors who were qualified in the teaching of Taichi. The 24 forms of simplified Taichi recommended as the popular health sport by the General Administration of Sport of China were applied.
Self-monitored exerciseBehavioural
Exercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise for 60 mins. 3 days per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Taichi | Experimental | The 24 forms of simplified TCC recommended as the popular health sport by the General Administration of Sport of China were applied. Receives: Behavioral: Taichi |
| Self-monitored exercise | Active comparator | Exercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise. Receives: Behavioral: Self-monitored exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
Measured: 3 months
Secondary outcomes (8)
Fasting plasma glucose (Glu)
Measured: 3 months
Fasting insulin (Ins)
Measured: 3 months
HOMA-IR
HOMA-IR = fasting insulin concentrations (mIU/L) ×fasting plasma glucose concentrations (mmol/L)/22.5
Measured: 3 months
Testosterone (T)
Measured: 3 months
Luteinizing hormone (LH)
Measured: 3 months
Follicle stimulating hormone (FSH)
Measured: 3 months
Waist/hip ratio
Measured: 3 months
Ferriman-Gallwey score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startOct 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Li, Heilongjiang University of Chinese Medicine
- Investigators
- Lihui Hou, Bachelor, Study chair, First Affiliated Hospital of Heilongjiang University Of Chinese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608554
- Sponsor's protocol ID
- Taichi for PCOS
- Status last verified
- Dec 2019
- First submitted
- 17 Nov 2015
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Li Y, Peng C, Zhang M, Xie L, Gao J, Wang Y, Gao Y, Hou L. Tai Chi for Overweight/Obese Adolescents and Young Women with Polycystic Ovary Syndrome: A Randomized Controlled Pilot Trial. Evid Based Complement Alternat Med. 2022 Jun 17;2022:4291477. doi: 10.1155/2022/4291477. eCollection 2022.
PubMed 35754690Li Y, Peng C, Cao G, Li W, Hou L. Tai chi for overweight/obese adolescent and young women with polycystic ovary syndrome: study protocol for a randomized controlled trial. Trials. 2018 Sep 20;19(1):512. doi: 10.1186/s13063-018-2893-z.
PubMed 30236149
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taichi for Treating Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT02608554
- Acronym / sponsor ID
- Taichi for PCOS
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovary sybdrome, Taichi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 18 Nov 2015 (estimated)
- 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.
The present study is a randomized pilot study, overweight/obese adolescent and young PCOS subjects will be assigned into two groups: Taichi arm and control arm. Hormonal profile and metabolic profile will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taichi | Experimental | Behavioral: TaichiThe 24 forms of simplified TCC recommended as the popular health sport by the General Administration of Sport of China were applied. |
| Self-monitored exercise | Active comparator | Behavioral: Self-monitored exerciseExercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged between 19 and 35 years;
- Diagnosis of PCOS according to the modified Rotterdam criteria;
- 2 years after menarche;
- Body mass index (BMI) equal to or greater than 23 kg/m*m.
Key exclusion criteria (3 listed)
- Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
- Patients with other endocrine disorder including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
- Patients with known severe organ dysfunction or mental illness.
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 |
|---|---|---|
| TaichiThe program of Taichi training consisted of 60 minutes exercise sessions, 3 days per week for 12 weeks, based on their original level of physical activity. Each session comprised 40 minutes of Taichi training plus a 10-minute warm-up and cool-down. The Taichi training was instructed by the same experienced Taichi instructors who were qualified in the teaching of Taichi. The 24 forms of simplified Taichi recommended as the popular health sport by the General Administration of Sport of China were applied. | Behavioural | Taichi |
| Self-monitored exerciseExercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise for 60 mins. 3 days per week for 12 weeks. | Behavioural | Self-monitored exercise |
Primary outcome
Body mass index (BMI)
Time frame: 3 months
8 secondary outcomes
Fasting plasma glucose (Glu)
Time frame: 3 months
Fasting insulin (Ins)
Time frame: 3 months
HOMA-IR
Time frame: 3 months
Testosterone (T)
Time frame: 3 months
Luteinizing hormone (LH)
Time frame: 3 months
Follicle stimulating hormone (FSH)
Time frame: 3 months
Waist/hip ratio
Time frame: 3 months
Ferriman-Gallwey score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 35754690Li Y, Peng C, Zhang M, Xie L, Gao J, Wang Y, Gao Y, Hou L. Tai Chi for Overweight/Obese Adolescents and Young Women with Polycystic Ovary Syndrome: A Randomized Controlled Pilot Trial. Evid Based Complement Alternat Med. 2022 Jun 17;2022:4291477. doi: 10.1155/2022/4291477. eCollection 2022.
- Derived from this study: PubMed 30236149Li Y, Peng C, Cao G, Li W, Hou L. Tai chi for overweight/obese adolescent and young women with polycystic ovary syndrome: study protocol for a randomized controlled trial. Trials. 2018 Sep 20;19(1):512. doi: 10.1186/s13063-018-2893-z.
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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.
Lihui Hou, Bachelor study chair
First Affiliated Hospital of Heilongjiang University Of Chinese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taichi and Self-monitored exercise in people with Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 1 site in China.
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 3 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 26 Dec 2019. 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 China. 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?
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 (BMI) (time frame: 3 months). 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 NCT02608554, which also lists 2 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 26 Dec 2019.