MenopauseNCT03236896
Studying the Impact of Exercise on Hot Flashes
A study testing Exercise and No exercise in people with Menopause, run by Texas Tech University Health Sciences Center, El Paso.
Trial summary
A prospective randomized pragmatic trial will be used to obtain data on energy expenditure, temperature changes and vasomotor symptoms at baseline, during the intervention in which participants will be randomized to either exercise or to not exercise, and at the end of the 12-week intervention. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Exercise and No exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 7 Jul 2017
- 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All subjects will be women
- All subjects will be between the ages of 35 and 60
- Must experience 7-20, moderate-severe hot flashes/day or 50-140, moderate-severe hot flashes/week for greater than two months. Moderate or severe hot flashes are recurrent periods of heat sensation and sweating that either do not interfere with or cause the cessation of an activity, respectively
- Must have had a bilateral salpingo-oophorectomy for >12 months or amenorrhea >12 months
- Must have a signed informed consent
- Must be able to function independently in all activities of daily living and be capable of reliable documentation for at least six consecutive weeks.
Who cannot join
- Men and children will not be included.
- Have current history of fever, cough, dysuria or diarrhea (i.e., signs of infection).
- Have >10% of hot flashes predictably related to certain food ingestion alcohol intake.
- Have a history of "easily blushing" and have >10% hot flashes associated with embarrassing events or migraines.
- Have an MI, stroke, functional decline within 1 month.
- Have a history of somatoform disorder.
Show all 12Show fewer
- Have an estimated creatinine clearance < 60ml/min.
- Fail to record data in the diary for >3 days during the 2 week baseline period.
- Unable or unwilling to make weekly visits over course of therapy
- Received any calcium channel antagonists or gabapentin for the past two weeks. Received estrogen, herbal estrogen, progestin, leuprolide acetate or tamoxifen within the past two months (if they would still like to participate, they will be required to undergo a 2 month washout period before enrolling in the study). Started clonidine, raloxifene or a new anti-depressant within the past month.
- Any contraindications to exercise or inability to exercise.
- Specific risks to resistance testing or training: Confirmed or suspected osteoporosis or osteopenia, musculo-skeletal injuries to involved joints, surgery within last year (includes eye surgery), hernia, Marfan syndrome, implanted pacemaker or defibrillator, low functional capacity (<4 METS), uncontrolled hypertension >160/100 mmHg represent a partial list of risks.
About this study
Official title: Studying the Impact of Exercise on Hot Flashes Using Mobile Fitbit Flex, MENQOL Scale and Hot Flash Diary
A prospective randomized pragmatic trial will be used to obtain data on energy expenditure, temperature changes and vasomotor symptoms at baseline, during the intervention in which participants will be randomized to either exercise or to not exercise, and at the end of the 12-week intervention.
Read the detailed description
During menopause, the main symptom that prompts women to seek medical attention is hot flashes. It is estimated that 75% of all menopausal women (approximately 50,000,000) will experience hot flashes, and that 15% will be severely affected. In addition to hot flashes, other significant climacteric symptoms include depression, insomnia, nervousness, fatigue, arthralgia, headache, vaginal dryness and night sweats. Most clinical trials assessing therapeutic efficacy use subjective reports (eg. questionnaires, diaries). The current gold standard for objective assessment of hot flashes is measuring the skin conductance level. However, there is still a relative discordancy between self reported and objectively detected hot flashes even with the use of skin conductance level. A combination of objective and subjective measures probably constitutes a valid assessment of vasomotor symptoms.
The menopausal transition is associated with a risk to increase in body weight and adiposity. Weight gain in the menopausal woman can be closely associated with aging but is also influenced by hormonal changes. Identifying modifiable factors that can prevent or attenuate theses changes is of great relevance. Resting energy expenditure decreases with age but also decreases with loss of ovarian function. There is little data on energy expenditure as it relates to the menopause and how influences such as exercise play a role in metabolic rate and how this may play a role in vasomotor symptoms. is an a portable monitor that will be used to collect minute by minute data on energy expenditure, physical activity and sleep monitoring. This data will be used to calculate temperature regulation. There are no studies using this device on women undergoing the menopause transition. Given the skin temperature fluxes that occur with hot flashes, it is possible that energy expenditure is not calculated correctly, since heat is used as a measure of energy expenditure. There are also no studies comparing this device to the current subjective evaluative methods like the hot flash diary and quality of life surveys. The purpose of this study is to generate preliminary data needed to conduct a larger trial.
- Conditions
- Menopause
- Being tested
- Exercise, No exercise
- Keywords
- Menopause, Hot Flash, MENQOL, Mobile exercise device
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Strength training exercises for older adults. All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.
No exerciseBehavioural
All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Active comparator | This group will participate in a weekly exercise regimen and actively log the physical activity in a diary. They will complete the daily hot flash diary, MENQOL scale and calorimeter. All subjects will complete questionnaire (MENQOL Scale,) before the start of the study, at the sixth week of the study and after the completion of the twelfth week. A 2-week baseline assessment of hot flashes using the hot flash diary and fitbit flex will be followed by 12 weeks of assessment during the exercise intervention. Receives: Behavioral: Exercise |
| No Exercise | Active comparator | They will complete the daily hot flash diary, MENQOL scale and calorimeter. All subjects will complete questionnaire (MENQOL Scale,) before the start of the study, at the sixth week of the study and after the completion of the twelfth week. A 2-week baseline assessment of hot flashes using the hot flash diary and fitbit flex will be followed by 12 weeks of assessment during the exercise intervention. Receives: Behavioral: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hot flash rate occurrence with strength training exercise.
Hot Flash Diary, strength training manual and Fitbit flex will be used
Measured: 12 weeks
Secondary outcomes (5)
Hot Flash Diary
Measure Hot Flash duration and severity
Measured: 14 weeks
Menopause-Specific Quality of Life Questionnaire (MENQOL)
Measure impact on daily life
Measured: 14 weeks
Calorimeter
Measure basel metabolic rate
Measured: 14 weeks
FitBit Data
Measure daily activity
Measured: 14 weeks
Strength training log
Record strength training performed
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study startOct 2015
- Primary completion30 Jun 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sireesha Reddy, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Sireesha Y Reddy, MD, Principal investigator, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236896
- Sponsor's protocol ID
- E14055
- Status last verified
- Sep 2019
- First submitted
- 18 Apr 2017
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kronenberg F. Hot flashes: epidemiology and physiology. Ann N Y Acad Sci. 1990;592:52-86; discussion 123-33. doi: 10.1111/j.1749-6632.1990.tb30316.x.
PubMed 2197954Kass-Annese B. Alternative therapies for menopause. Clin Obstet Gynecol. 2000 Mar;43(1):162-83. doi: 10.1097/00003081-200003000-00018.
PubMed 10694998Guttuso TJ Jr. Gabapentin's effects on hot flashes and hypothermia. Neurology. 2000 Jun 13;54(11):2161-3. doi: 10.1212/wnl.54.11.2161.
PubMed 10851385Campbell S, Whitehead M. Oestrogen therapy and the menopausal syndrome. Clin Obstet Gynaecol. 1977 Apr;4(1):31-47.
PubMed 322905Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.
PubMed 8844630Reddy SY, Warner H, Guttuso T Jr, Messing S, DiGrazio W, Thornburg L, Guzick DS. Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):41-8. doi: 10.1097/01.AOG.0000222383.43913.ed.
PubMed 16816054Thurston RC, Sowers MR, Chang Y, Sternfeld B, Gold EB, Johnston JM, Matthews KA. Adiposity and reporting of vasomotor symptoms among midlife women: the study of women's health across the nation. Am J Epidemiol. 2008 Jan 1;167(1):78-85. doi: 10.1093/aje/kwm244. Epub 2007 Sep 19.
PubMed 17881385Tremollieres FA, Pouilles JM, Ribot CA. Relative influence of age and menopause on total and regional body composition changes in postmenopausal women. Am J Obstet Gynecol. 1996 Dec;175(6):1594-600. doi: 10.1016/s0002-9378(96)70111-4.
PubMed 8987946
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Impact of Exercise on Hot Flashes Using Mobile Fitbit Flex, MENQOL Scale and Hot Flash Diary
- ClinicalTrials.gov ID
- NCT03236896
- Acronym / sponsor ID
- E14055
- Conditions
- Menopause
- Keywords
- Menopause, Hot Flash, MENQOL, Mobile exercise device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 2 Aug 2017 (actual)
- 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.
A prospective randomized pragmatic trial will be used to obtain data on energy expenditure, temperature changes and vasomotor symptoms at baseline, during the intervention in which participants will be randomized to either exercise or to not exercise, and at the end of the 12-week intervention.
Detailed description
During menopause, the main symptom that prompts women to seek medical attention is hot flashes. It is estimated that 75% of all menopausal women (approximately 50,000,000) will experience hot flashes, and that 15% will be severely affected. In addition to hot flashes, other significant climacteric symptoms include depression, insomnia, nervousness, fatigue, arthralgia, headache, vaginal dryness and night sweats. Most clinical trials assessing therapeutic efficacy use subjective reports (eg. questionnaires, diaries). The current gold standard for objective assessment of hot flashes is measuring the skin conductance level. However, there is still a relative discordancy between self reported and objectively detected hot flashes even with the use of skin conductance level. A combination of objective and subjective measures probably constitutes a valid assessment of vasomotor symptoms.
The menopausal transition is associated with a risk to increase in body weight and adiposity. Weight gain in the menopausal woman can be closely associated with aging but is also influenced by hormonal changes. Identifying modifiable factors that can prevent or attenuate theses changes is of great relevance. Resting energy expenditure decreases with age but also decreases with loss of ovarian function. There is little data on energy expenditure as it relates to the menopause and how influences such as exercise play a role in metabolic rate and how this may play a role in vasomotor symptoms. is an a portable monitor that will be used to collect minute by minute data on energy expenditure, physical activity and sleep monitoring. This data will be used to calculate temperature regulation. There are no studies using this device on women undergoing the menopause transition. Given the skin temperature fluxes that occur with hot flashes, it is possible that energy expenditure is not calculated correctly, since heat is used as a measure of energy expenditure. There are also no studies comparing this device to the current subjective evaluative methods like the hot flash diary and quality of life surveys. The purpose of this study is to generate preliminary data needed to conduct a larger trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Active comparator | Behavioral: ExerciseThis group will participate in a weekly exercise regimen and actively log the physical activity in a diary. They will complete the daily hot flash diary, MENQOL scale and calorimeter. All subjects will complete questionnaire (MENQOL Scale,) before the start of the study, at the sixth week of the study and after the completion of the twelfth week. A 2-week baseline assessment of hot flashes using the hot flash diary and fitbit flex will be followed by 12 weeks of assessment during the exercise intervention. |
| No Exercise | Active comparator | Behavioral: No exerciseThey will complete the daily hot flash diary, MENQOL scale and calorimeter. All subjects will complete questionnaire (MENQOL Scale,) before the start of the study, at the sixth week of the study and after the completion of the twelfth week. A 2-week baseline assessment of hot flashes using the hot flash diary and fitbit flex will be followed by 12 weeks of assessment during the exercise intervention. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All subjects will be women
- All subjects will be between the ages of 35 and 60
- Must experience 7-20, moderate-severe hot flashes/day or 50-140, moderate-severe hot flashes/week for greater than two months. Moderate or severe hot flashes are recurrent periods of heat sensation and sweating that either do not interfere with or cause the cessation of an activity, respectively
- Must have had a bilateral salpingo-oophorectomy for >12 months or amenorrhea >12 months
- Must have a signed informed consent
Key exclusion criteria (12 listed)
- Men and children will not be included.
- Have current history of fever, cough, dysuria or diarrhea (i.e., signs of infection).
- Have >10% of hot flashes predictably related to certain food ingestion alcohol intake.
- Have a history of "easily blushing" and have >10% hot flashes associated with embarrassing events or migraines.
- Have an MI, stroke, functional decline within 1 month.
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 |
|---|---|---|
| ExerciseStrength training exercises for older adults. All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study. | Behavioural | Exercise Intervention |
| No exerciseAll subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study. | Behavioural | No Exercise |
Primary outcome
Change in hot flash rate occurrence with strength training exercise.
Time frame: 12 weeks
Hot Flash Diary, strength training manual and Fitbit flex will be used
5 secondary outcomes
Hot Flash Diary
Time frame: 14 weeks
Menopause-Specific Quality of Life Questionnaire (MENQOL)
Time frame: 14 weeks
Calorimeter
Time frame: 14 weeks
FitBit Data
Time frame: 14 weeks
Strength training log
Time frame: 12 weeks
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 16 Sep 2019.
- Background: PubMed 2197954Kronenberg F. Hot flashes: epidemiology and physiology. Ann N Y Acad Sci. 1990;592:52-86; discussion 123-33. doi: 10.1111/j.1749-6632.1990.tb30316.x.
- Background: PubMed 10694998Kass-Annese B. Alternative therapies for menopause. Clin Obstet Gynecol. 2000 Mar;43(1):162-83. doi: 10.1097/00003081-200003000-00018.
- Background: PubMed 10851385Guttuso TJ Jr. Gabapentin's effects on hot flashes and hypothermia. Neurology. 2000 Jun 13;54(11):2161-3. doi: 10.1212/wnl.54.11.2161.
- Background: PubMed 322905Campbell S, Whitehead M. Oestrogen therapy and the menopausal syndrome. Clin Obstet Gynaecol. 1977 Apr;4(1):31-47.
- Background: PubMed 8844630Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.
- Background: PubMed 16816054Reddy SY, Warner H, Guttuso T Jr, Messing S, DiGrazio W, Thornburg L, Guzick DS. Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):41-8. doi: 10.1097/01.AOG.0000222383.43913.ed.
- Background: PubMed 17881385Thurston RC, Sowers MR, Chang Y, Sternfeld B, Gold EB, Johnston JM, Matthews KA. Adiposity and reporting of vasomotor symptoms among midlife women: the study of women's health across the nation. Am J Epidemiol. 2008 Jan 1;167(1):78-85. doi: 10.1093/aje/kwm244. Epub 2007 Sep 19.
- Background: PubMed 8987946Tremollieres FA, Pouilles JM, Ribot CA. Relative influence of age and menopause on total and regional body composition changes in postmenopausal women. Am J Obstet Gynecol. 1996 Dec;175(6):1594-600. doi: 10.1016/s0002-9378(96)70111-4.
- Individual participant dataSharing planned: No
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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.
Sireesha Y Reddy, MD principal investigator
Texas Tech University Health Sciences Center, El Paso
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and No exercise in people with Menopause, run by Texas Tech University Health Sciences Center, El Paso.
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 12 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 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in hot flash rate occurrence with strength training exercise. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03236896, which also lists 8 linked publications.
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 16 Sep 2019.