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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hot flash rate occurrence with strength training exercise. | Hot Flash Diary, strength training manual and Fitbit flex will be used | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hot Flash Diary | Measure Hot Flash duration and severity | 14 weeks |
| Menopause-Specific Quality of Life Questionnaire (MENQOL) | Measure impact on daily life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sireesha Y Reddy, MD | Texas Tech University Health Sciences Center, El Paso | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2197954 | Background | 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. | |
| 10694998 | Background | Kass-Annese B. Alternative therapies for menopause. Clin Obstet Gynecol. 2000 Mar;43(1):162-83. doi: 10.1097/00003081-200003000-00018. |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| No exercise | Behavioral | All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study. |
|
| 14 weeks |
| Calorimeter | Measure basel metabolic rate | 14 weeks |
| FitBit Data | Measure daily activity | 14 weeks |
| Strength training log | Record strength training performed | 12 weeks |
| 10851385 | Background | 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. |
| 322905 | Background | Campbell S, Whitehead M. Oestrogen therapy and the menopausal syndrome. Clin Obstet Gynaecol. 1977 Apr;4(1):31-47. |
| 8844630 | Background | 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. |
| 16816054 | Background | 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. |
| 17881385 | Background | 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. |
| 8987946 | Background | 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. |