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

Sponsor

Heilongjiang University of Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02608554

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Behavioral: Taichi Behavioral: Self-monitored exercise	N/A

Study Design

Study Type:

Interventional

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 :

Oct 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Mar 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Body mass index (BMI) [3 months]

Secondary Outcome Measures

Fasting plasma glucose (Glu) [3 months]
Fasting insulin (Ins) [3 months]
HOMA-IR [3 months]
HOMA-IR = fasting insulin concentrations (mIU/L) ×fasting plasma glucose concentrations (mmol/L)/22.5
Testosterone (T) [3 months]
Luteinizing hormone (LH) [3 months]
Follicle stimulating hormone (FSH) [3 months]
Waist/hip ratio [3 months]
Ferriman-Gallwey score [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang	China	150040

Sponsors and Collaborators

Heilongjiang University of Chinese Medicine

Investigators

Study Chair: Lihui Hou, Bachelor, First Affiliated Hospital of Heilongjiang University Of Chinese

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Nov 18, 2015

Last Update Posted:

Dec 26, 2019

Last Verified:

Dec 1, 2019

Keywords provided by Yan Li, Associate seiner physician, Heilongjiang University of Chinese Medicine

Polycystic ovary sybdrome

Taichi

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Overweight

Study Results

No Results Posted as of Dec 26, 2019