NCT01073397

Brief Summary

The purpose of this research study is to compare yoga and health and wellness classes for helping perimenopausal or newly postmenopausal women who are experiencing hot flashes. The investigators want to learn about the effects of yoga and health and wellness classes on symptoms and other quality of life issues. The results of this study may provide important knowledge to women and clinicians who counsel women with menopausal hot flashes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

February 22, 2010

Last Update Submit

August 8, 2018

Conditions

Vasomotor Symptoms

Keywords

MenopauseHot FlashesVasomotor symptomsYoga

Outcome Measures

Primary Outcomes (1)

  • Subjective Hot Flashes

    Subjective hot flashes measured by daily diaries

    Weekly

Secondary Outcomes (2)

  • Objective hot flashes

    3 days

  • Hot flash interference

    1 week

Study Arms (3)

Behavioral

EXPERIMENTAL

Weekly Integral Yoga sessions lasting 90 minutes for 10 weeks with home practice.

Behavioral: Yoga

Health and Wellness Classes

ACTIVE COMPARATOR

Weekly classes on health and wellness lasting 90 minutes for 10 weeks, with additional home practice

Behavioral: Yoga

Waitlist

NO INTERVENTION

This group receives usual care for 10 weeks and is then randomized to one of the study arms.

Interventions

YogaBEHAVIORAL

Integral Yoga class (90 minutes per class), Once weekly for 10 weeks

BehavioralHealth and Wellness Classes

Eligibility Criteria

Age45 Years - 58 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least 2 months since last menses
  • Age 45-58 years
  • Moderate to severe vasomotor symptoms for at least 4 weeks (at least 4/day on average)
  • Self-reported general good health
  • Adequate English to understand informed consent form, questionnaires, and converse with study staff
  • Agree not to use pharmaceutical agents for treating hot flashes during the study

You may not qualify if:

  • Hormone therapy use within 12 weeks prior to study screening, including systemic estrogen, progestin or androgen therapy
  • Selective estrogen receptor modulator (Evista® and Novaldex®) or aromatase inhibitor use within 6 months
  • Cancer at any time
  • Untreated thyroid disease
  • Initiation of herbal or nutritional supplements for hot flashes within the past 4 weeks
  • Significant psychiatric disorder, including regular use of antidepressants or anxiolytics
  • Regular use of clonidine or Bellergal® within the past 12 weeks
  • Any past use of yoga for hot flashes
  • Yoga or Acupuncture for any reason within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Yoga

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Nancy E Avis, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)