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

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Taichi
Self-monitored exercise
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary sybdrome, Taichi

Eligibility Criteria

19 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Taichi

Self-monitored exercise

Arm Description

The 24 forms of simplified TCC recommended as the popular health sport by the General Administration of Sport of China were applied.

Exercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise.

Outcomes

Primary Outcome Measures

Body mass index (BMI)

Secondary Outcome Measures

Fasting plasma glucose (Glu)
Fasting insulin (Ins)
HOMA-IR
HOMA-IR = fasting insulin concentrations (mIU/L) ×fasting plasma glucose concentrations (mmol/L)/22.5
Testosterone (T)
Luteinizing hormone (LH)
Follicle stimulating hormone (FSH)
Waist/hip ratio
Ferriman-Gallwey score

Full Information

First Posted
November 17, 2015
Last Updated
December 23, 2019
Sponsor
Heilongjiang University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02608554
Brief Title
Taichi for Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)
Official Title
Taichi for Treating Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary sybdrome, Taichi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taichi
Arm Type
Experimental
Arm Description
The 24 forms of simplified TCC recommended as the popular health sport by the General Administration of Sport of China were applied.
Arm Title
Self-monitored exercise
Arm Type
Active Comparator
Arm Description
Exercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise.
Intervention Type
Behavioral
Intervention Name(s)
Taichi
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-monitored exercise
Intervention Description
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 Measure Information:
Title
Body mass index (BMI)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Fasting plasma glucose (Glu)
Time Frame
3 months
Title
Fasting insulin (Ins)
Time Frame
3 months
Title
HOMA-IR
Description
HOMA-IR = fasting insulin concentrations (mIU/L) ×fasting plasma glucose concentrations (mmol/L)/22.5
Time Frame
3 months
Title
Testosterone (T)
Time Frame
3 months
Title
Luteinizing hormone (LH)
Time Frame
3 months
Title
Follicle stimulating hormone (FSH)
Time Frame
3 months
Title
Waist/hip ratio
Time Frame
3 months
Title
Ferriman-Gallwey score
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lihui Hou, Bachelor
Organizational Affiliation
First Affiliated Hospital of Heilongjiang University Of Chinese
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35754690
Citation
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.
Results Reference
derived
PubMed Identifier
30236149
Citation
Li 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.
Results Reference
derived

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

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