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Yoga for Treatment of Hot Flashes

Primary Purpose

Menopause-Related Hot Flashes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause-Related Hot Flashes focused on measuring Menopausal Symptoms, Hot Flashes, Yoga

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)Accepts Healthy Volunteers

Inclusion Criteria: Self-report ≥4 moderate to severe hot flashes per day or ≥ 30 moderate to severe hot flashes per week. Successful completion of a Hot Flash Diary. Able and willing to attend yoga training sessions, maintain yoga logs, and practice yoga at home. Exclusion Criteria: Inability to sign an informed consent or fill out questionnaires. 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. Use of raloxifene or tamoxifen within three months of enrollment. 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. -

Sites / Locations

  • UCSF Women's Health Clinical Research Center

Outcomes

Primary Outcome Measures

Reduction of number and severity of hot flashes will be summarized by the sample averages.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2006
Last Updated
January 25, 2006
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00283205
Brief Title
Yoga for Treatment of Hot Flashes
Official Title
Yoga for Treatment of Hot Flashes and Menopausal Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause-Related Hot Flashes
Keywords
Menopausal Symptoms, Hot Flashes, Yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Yoga
Primary Outcome Measure Information:
Title
Reduction of number and severity of hot flashes will be summarized by the sample averages.

10. Eligibility

Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Self-report ≥4 moderate to severe hot flashes per day or ≥ 30 moderate to severe hot flashes per week. Successful completion of a Hot Flash Diary. Able and willing to attend yoga training sessions, maintain yoga logs, and practice yoga at home. Exclusion Criteria: Inability to sign an informed consent or fill out questionnaires. 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. Use of raloxifene or tamoxifen within three months of enrollment. 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Grady, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Women's Health Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Yoga for Treatment of Hot Flashes

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