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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

January 25, 2006
January 25, 2006
September 2005
Not Provided
Reduction of number and severity of hot flashes will be summarized by the sample averages.
Same as current
No Changes Posted
Not Provided
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Yoga for Treatment of Hot Flashes
Yoga for Treatment of Hot Flashes and Menopausal Symptoms

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Menopause-Related Hot Flashes
Behavioral: Yoga
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2005
Not Provided

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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Not Provided
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283205
H5287-26599
Not Provided
Not Provided
University of California, San Francisco
Not Provided
Principal Investigator: Deborah Grady, MD, MPH University of California, San Francisco
University of California, San Francisco
March 2005

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