Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Procedure: Electroacupuncture; Procedure: Physical exercise; Procedure: Untreated control

• Registration Number: NCT00484705
• Lead Sponsor: Göteborg University

Brief Summary

Hypothesis:

The overall hypothesis is that women with PCOS, both obese and non-obese, have larger adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these changes are associated with high sympathetic nerve activity, hyperandrogenism hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular disease (CVD) as well as psychological distress and reduced quality of life. Physical exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced disturbances.

Detailed Description

Primary outcome: Changes in androgen concentrations and menstrual pattern

Secondary outcome: changes in sympathetic nerve activity, uterus peristalsis, ovarian morphology, adipose tissue related variables, insulin sensitivity, coagulation factors and health related quality of life and symptoms of anxiety and depression.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-06-08
• Study First Submitted QC: 2007-06-08
• Study First Posted: 2007-06-11
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-09
• Last Update Posted: 2009-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• To get the diagnosis polycystic ovary syndrome (PCOS), ultrasonography should reveal at least 1 ovary with PCO according to the Rotterdam diagnostic criteria as well as one of the following two symptoms:

  1. Anovulation/oligoovulation defined as ≥ 35 days during the last year
  2. Clinical signs of hyperandrogenism (hirsutism, acne)

Exclusion Criteria

• Cardiovascular disease
• Diabetes mellitus
• Other endocrine disease (congenital adrenal hyperplasia, androgen producing tumour, Cushing's syndrome)
• Estrogen/gestagen treatment during the last 3 months
• Breast-feeding the last 6 months
• Antiandrogen treatment the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Low-frequency electro-acupuncture	Electroacupuncture	-
Physical exercise	Physical exercise	-
Untreated control	Untreated control	-

Primary Outcome Measures

Name	Time	Method
To measure if physical exercise and electro-acupuncture restores endocrine, neuroendocrine, metabolic and immunological disturbances related to sympathetic nerve activity as well as psychological distress and improve quality of life in women with PCOS.	One year

Trial Locations

Locations (1)

Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University; 🇸🇪 Göteborg, Sweden