AzTrials
AzTrials

Vasomotor SymptomsGLAMNCT01073397

Effect of Yoga on Objective and Subjective Menopausal Hot Flashes

A study testing Yoga in people with Vasomotor Symptoms, run by Wake Forest University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 58 years, women onlyHealthy volunteers can take part
Conditions the study is for
Vasomotor Symptoms
What is being tested?
Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
Jan 2010to May 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 58 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Yoga
Keywords
Menopause, Hot Flashes, Vasomotor symptoms, Yoga
Medical subject headings
Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YogaBehavioural

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

Study groups in NCT01073397
Study groupRoleWhat they receive
BehavioralExperimentalWeekly Integral Yoga sessions lasting 90 minutes for 10 weeks with home practice.
Receives: Behavioral: Yoga
Health and Wellness ClassesActive comparatorWeekly classes on health and wellness lasting 90 minutes for 10 weeks, with additional home practice
Receives: Behavioral: Yoga
WaitlistNo interventionThis group receives usual care for 10 weeks and is then randomized to one of the study arms.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective Hot Flashes

    Subjective hot flashes measured by daily diaries

    Measured: Weekly

Secondary outcomes (2)
  1. Objective hot flashes

    Objective hot flashes measured by skin conductance.

    Measured: 3 days

  2. Hot flash interference

    This measure assesses the impact of hot flashes on daily activities and quality of life.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01073397
Sponsor's protocol ID
IRB00009138
Other IDs
1R21AT004234-01A2
Acronym
GLAM
Status last verified
Aug 2018
First submitted
22 Feb 2010
Last updated
10 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Yoga in people with Vasomotor Symptoms, run by Wake Forest University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Hot Flashes (time frame: Weekly). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in