Effect of Yoga on Objective and Subjective Menopausal Hot Flashes (GLAM)

Effectiveness of Integral Yoga on Objective and Subjective Menopausal Hot Flashes

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.

Study Overview

• Status: Completed
• Conditions: Vasomotor Symptoms
• Intervention / Treatment: Behavioral: Yoga

Detailed Description

Hot flashes and/or night sweats are the most common and troubling symptoms associated with menopause. It is estimated that 64% to 87% of women report experiencing hot flashes for an average of about 4 years. For many women, these symptoms are frequent and severe enough to become debilitating and interfere with daily activities. They often occur at night, disturbing sleep and leading to daytime irritability, fatigue and depressed mood. About 30-40% of menopausal women seek medical help for hot flashes. Relief from hot flashes has been shown to be the primary reason that women initiate hormone therapy (HT).

HT is currently the gold standard for treatment of vasomotor symptoms. A Cochrane Database systematic review showed a 75% reduction in hot flash frequency with hormone therapy compared to placebo.1 However, recent findings from the Women's Health Initiative (WHI) trial indicate that benefits of HT are outweighed by risks, such as coronary heart disease, stroke, pulmonary embolism, breast cancer, and probable dementia. The wide publicity of the WHI results has heightened women's concerns about taking HT and many women have sought alternative treatments for hot flashes. These alternatives include other pharmaceutical agents, herbal or dietary remedies, and behavioral therapies. Unfortunately, many of these agents have a high incidence of side effects or have not been shown to be effective. A recent NIH conference has called for more research on alternative treatments for hot flashes.

Behavioral interventions involving relaxation and slow deep, abdominal breathing have been found to be useful for reducing mild- to moderate-intensity hot flashes. Although the physiological mechanisms for the effectiveness of these interventions are not completely understood, there is some suggestion that they may help reduce sympathetic activity which is related to the narrowing of the thermoneutral zone. It is currently thought that hot flashes are linked to a disruption in thermoregulation and that elevated levels of brain norepinephrine may be the primary mechanism for altered thermoregulation. Breathing techniques form the most integral core of any yoga practice which involves the combination of physical postures (asanas), breathing (pranayama), and deep relaxation (savasana). Despite suggestions that yoga may be beneficial for the relief of hot flashes, these potential benefits have not been well-studied.

To date, treatment efficacy for hot flashes has been limited to self-reported, subjective symptoms. While subjective hot flashes are important from a woman's perspective in her decision-making with respect to treatment, research has shown that they can be influenced by mood and reporting biases. Objective measures are not subject to these biases and have the advantage of providing insight as to whether an intervention has a physiological effect. However, until recently, reliable objective measures that could be used in an ambulatory setting were not available. NCCAM has recently funded the development of new technologies to monitor objective hot flashes in an ambulatory setting, as measured by skin conductance. This technology greatly enhances our ability to fully evaluate the impact of treatment on both subjective and objective hot flashes.

The primary goal of this R21 pilot grant is to obtain preliminary data on the efficacy of Integral Yoga for reducing self-reported menopausal hot flashes. Secondary aims are to determine the impact of yoga on objective hot flashes and other outcomes and study feasibility. Our primary hypothesis will be a greater reduction in subjective hot flash frequency and severity in the yoga group than in two control groups. Secondary outcomes will include a greater reduction in objective hot flash frequency; a greater decrease in hot flash interference; and greater improvement in sleep, other symptoms, mood, perceived stress, and overall quality of life in the yoga group.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 58 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Behavioral; Weekly Integral Yoga sessions lasting 90 minutes for 10 weeks with home practice.	Behavioral: Yoga; Integral Yoga class (90 minutes per class), Once weekly for 10 weeks
ACTIVE_COMPARATOR: Health and Wellness Classes; Weekly classes on health and wellness lasting 90 minutes for 10 weeks, with additional home practice	Behavioral: Yoga; Integral Yoga class (90 minutes per class), Once weekly for 10 weeks
NO_INTERVENTION: Waitlist; This group receives usual care for 10 weeks and is then randomized to one of the study arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Hot Flashes	Subjective hot flashes measured by daily diaries	Weekly

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective hot flashes	Objective hot flashes measured by skin conductance.	3 days
Hot flash interference	This measure assesses the impact of hot flashes on daily activities and quality of life.	1 week

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Nancy E Avis, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (ESTIMATE): February 23, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Yoga; Menopause; Hot Flashes; Vasomotor symptoms
• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: IRB00009138; 1R21AT004234-01A2 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No