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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02608554
• Other study ID #: Taichi for PCOS
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: December 2019
• Source: Heilongjiang University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital, Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index (BMI)		3 months
Secondary	Fasting plasma glucose (Glu)		3 months
Secondary	Fasting insulin (Ins)		3 months
Secondary	HOMA-IR	HOMA-IR = fasting insulin concentrations (mIU/L) ×fasting plasma glucose concentrations (mmol/L)/22.5	3 months
Secondary	Testosterone (T)		3 months
Secondary	Luteinizing hormone (LH)		3 months
Secondary	Follicle stimulating hormone (FSH)		3 months
Secondary	Waist/hip ratio		3 months
Secondary	Ferriman-Gallwey score		3 months