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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Vasomotor Symptoms
- 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 group | Role | What they receive |
|---|---|---|
| Behavioral | Experimental | Weekly Integral Yoga sessions lasting 90 minutes for 10 weeks with home practice. Receives: Behavioral: Yoga |
| Health and Wellness Classes | Active comparator | Weekly classes on health and wellness lasting 90 minutes for 10 weeks, with additional home practice Receives: Behavioral: Yoga |
| Waitlist | No intervention | This 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.
Subjective Hot Flashes
Subjective hot flashes measured by daily diaries
Measured: Weekly
Secondary outcomes (2)
Objective hot flashes
Objective hot flashes measured by skin conductance.
Measured: 3 days
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.
- First posted23 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Nancy E Avis, PhD, Principal investigator, Wake Forest University Health Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Integral Yoga on Objective and Subjective Menopausal Hot Flashes
- ClinicalTrials.gov ID
- NCT01073397
- Acronym / sponsor ID
- GLAM / IRB00009138
- Conditions
- Vasomotor Symptoms
- Keywords
- Menopause, Hot Flashes, Vasomotor symptoms, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Experimental | Behavioral: YogaWeekly Integral Yoga sessions lasting 90 minutes for 10 weeks with home practice. |
| Health and Wellness Classes | Active comparator | Behavioral: YogaWeekly classes on health and wellness lasting 90 minutes for 10 weeks, with additional home practice |
| Waitlist | No intervention | –This group receives usual care for 10 weeks and is then randomized to one of the study arms. |
Who may qualify
- Ages
- 45 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaIntegral Yoga class (90 minutes per class), Once weekly for 10 weeks | Behavioural | Behavioral, Health and Wellness Classes |
Primary outcome
Subjective Hot Flashes
Time frame: Weekly
Subjective hot flashes measured by daily diaries
2 secondary outcomes
Objective hot flashes
Time frame: 3 days
Hot flash interference
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy E Avis, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
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.