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

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.

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Behavioral: Taichi; Behavioral: Self-monitored exercise

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body mass index (BMI)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting plasma glucose (Glu)		3 months
Fasting insulin (Ins)		3 months
HOMA-IR	HOMA-IR = fasting insulin concentrations (mIU/L) ×fasting plasma glucose concentrations (mmol/L)/22.5	3 months
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

Collaborators and Investigators

• Sponsor: Heilongjiang University of Chinese Medicine

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): March 31, 2020

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (ESTIMATE): November 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Polycystic ovary sybdrome; Taichi
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Body Weight; Polycystic Ovary Syndrome; Syndrome; Overweight
• Other Study ID Numbers: Taichi for PCOS