Clinical trial NCT03236896: Studying the Impact of Exercise on Hot Flashes
Official title: Studying the Impact of Exercise on Hot Flashes Using Mobile Fitbit Flex, MENQOL Scale and Hot Flash Diary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Menopause
Hot Flash
MENQOL
Mobile exercise device
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 35
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change in hot flash rate occurrence with strength training exercise.
timeFrame: 12 weeks
Secondary outcomes:
measure: Hot Flash Diary
timeFrame: 14 weeks
measure: Menopause-Specific Quality of Life Questionnaire (MENQOL)
timeFrame: 14 weeks
measure: Calorimeter
timeFrame: 14 weeks
measure: FitBit Data
timeFrame: 14 weeks
measure: Strength training log
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Texas Tech University Health Sciences Center, El Paso
name: Sireesha Y Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kass-Annese B. Alternative therapies for menopause. Clin Obstet Gynecol. 2000 Mar;43(1):162-83. doi: 10.1097/00003081-200003000-00018.
citation: Guttuso 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.
citation: Campbell S, Whitehead M. Oestrogen therapy and the menopausal syndrome. Clin Obstet Gynaecol. 1977 Apr;4(1):31-47.
citation: Hilditch 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.
citation: Reddy 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.
citation: Thurston 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.
citation: Tremollieres 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.