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Yoga for Treatment of Hot Flashes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00283205
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : January 27, 2006
Sponsor:
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE January 25, 2006
First Posted Date  ICMJE January 27, 2006
Last Update Posted Date January 27, 2006
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2006)
Reduction of number and severity of hot flashes will be summarized by the sample averages.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga for Treatment of Hot Flashes
Official Title  ICMJE Yoga for Treatment of Hot Flashes and Menopausal Symptoms
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Menopause-Related Hot Flashes
Intervention  ICMJE Behavioral: Yoga
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 25, 2006)
12
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE Not Provided
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283205
Other Study ID Numbers  ICMJE H5287-26599
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deborah Grady, MD, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP