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Taichi for Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608554
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Yan Li, Heilongjiang University of Chinese Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: Taichi Behavioral: Self-monitored exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Taichi for Treating Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Taichi
The 24 forms of simplified TCC recommended as the popular health sport by the General Administration of Sport of China were applied.
Behavioral: Taichi
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.

Active Comparator: Self-monitored exercise
Exercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise.
Behavioral: Self-monitored exercise
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.




Primary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Fasting plasma glucose (Glu) [ Time Frame: 3 months ]
  2. Fasting insulin (Ins) [ Time Frame: 3 months ]
  3. HOMA-IR [ Time Frame: 3 months ]
    HOMA-IR = fasting insulin concentrations (mIU/L) ×fasting plasma glucose concentrations (mmol/L)/22.5

  4. Testosterone (T) [ Time Frame: 3 months ]
  5. Luteinizing hormone (LH) [ Time Frame: 3 months ]
  6. Follicle stimulating hormone (FSH) [ Time Frame: 3 months ]
  7. Waist/hip ratio [ Time Frame: 3 months ]
  8. Ferriman-Gallwey score [ Time Frame: 3 months ]


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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608554


Locations
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China, Heilongjiang
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China, 150040
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
Investigators
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Study Chair: Lihui Hou, Bachelor First Affiliated Hospital of Heilongjiang University Of Chinese

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yan Li, Associate seiner physician, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT02608554    
Other Study ID Numbers: Taichi for PCOS
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Keywords provided by Yan Li, Heilongjiang University of Chinese Medicine:
Polycystic ovary sybdrome
Taichi
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Overweight
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases