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Yoga for Treatment of Hot Flashes

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00283205
First received: January 25, 2006
Last updated: NA
Last verified: March 2005
History: No changes posted
  Purpose

The Yoga for Treatment of Hot Flashes and Menopausal Symptoms is an uncontrolled pilot clinical trial to determine the feasibility of recruitment and of evaluating yoga for the relief of menopausal hot flashes in 12 peri- or postmenopausal women. Participants will attend an Introductory Yoga Workshop, 8 yoga training sessions in 8 weeks, be assessed clinically before, during, and after training and contacted by telephone 3 months later.


Condition Intervention
Menopause-Related Hot Flashes
 Behavioral: Yoga

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yoga for Treatment of Hot Flashes and Menopausal Symptoms

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Reduction of number and severity of hot flashes will be summarized by the sample averages.
Estimated Enrollment: 12
Study Start Date: September 2005
Estimated Study Completion Date: December 2005
Detailed Description:

This is an uncontrolled pilot trial of yoga among 12 healthy peri- or postmenopausal women experiencing at least 4 hot flashes per day or 30 hot flashes per week. Participants will complete a Screening and Baseline Visit, and then be taught yoga during weekly sessions that will be held in the evening at the Laurel Heights Conference Center. The yoga postures and breathing techniques will be taught by a qualified and certified yoga instructor using the standardized protocol determined by a Yoga Expert Panel. Each group yoga session will take approximately 90 minutes. Participants will also be required to practice yoga at home at least 3 times per week, and be given yoga materials (mat, blocks, straps), and an instruction manual for their use at home. They will be asked to keep a calendar log of the dates/times that they practiced yoga at home. Outcomes will be assessed midway through the yoga training and at a Final Visit.

The main efficacy outcomes are change in number of hot flashes per week and change in severity of hot flashes from baseline to post-training reported on a 7-day diary. We will also measure changes in sleep and quality of life.

  Eligibility
Ages Eligible for Study:   40 Years to 65 Years
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Self-report ≥4 moderate to severe hot flashes per day or ≥ 30 moderate to severe hot flashes per week.
  2. Successful completion of a Hot Flash Diary.
  3. Able and willing to attend yoga training sessions, maintain yoga logs, and practice yoga at home.

Exclusion Criteria:

  1. Inability to sign an informed consent or fill out questionnaires.
  2. Use of other treatments for hot flashes (estrogens, progestins, clonidine, selective serotonin reuptake inhibitors,relaxation techniques or acupuncture) within 4 weeks of enrollment in the trial and do not agree to refrain from using these therapies for the duration of the trial.
  3. Use of raloxifene or tamoxifen within three months of enrollment.

  4. Any condition that, in the investigator’s opinion, would preclude the participant from being able to understand and follow the yoga training or from completing the trial, including severe illness, plans to move, substance abuse, significant psychiatric problems, or dementia.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283205

Locations
United States, California
UCSF Women's Health Clinical Research Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Deborah Grady, MD, MPH University of California, San Francisco
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00283205     History of Changes
Other Study ID Numbers: H5287-26599
Study First Received: January 25, 2006
Last Updated: January 25, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Menopausal Symptoms
Hot Flashes
Yoga

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015