NCT02608554

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

3.2 years

First QC Date

November 17, 2015

Last Update Submit

December 23, 2019

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary sybdromeTaichi

Outcome Measures

Primary Outcomes (1)

  • Body mass index (BMI)

    3 months

Secondary Outcomes (8)

  • Fasting plasma glucose (Glu)

    3 months

  • Fasting insulin (Ins)

    3 months

  • HOMA-IR

    3 months

  • Testosterone (T)

    3 months

  • Luteinizing hormone (LH)

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Taichi

EXPERIMENTAL

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

Behavioral: Taichi

Self-monitored exercise

ACTIVE COMPARATOR

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

Behavioral: Self-monitored exercise

Interventions

TaichiBEHAVIORAL

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.

Taichi
Self-monitored exerciseBEHAVIORAL

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.

Self-monitored exercise

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged between 19 and 35 years;
  • Diagnosis of PCOS according to the modified Rotterdam criteria;
  • years after menarche;
  • Body mass index (BMI) equal to or greater than 23 kg/m\*m.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150040, China

Location

Related Publications (2)

  • 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.

    PMID: 35754690DERIVED

  • 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.

    PMID: 30236149DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Lihui Hou, Bachelor

    First Affiliated Hospital of Heilongjiang University Of Chinese

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate seiner physician

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 18, 2015

Study Start

October 1, 2016

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

December 26, 2019

Record last verified: 2019-12

Locations

CN(1)