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Studying the Impact of Exercise on Hot Flashes

Primary Purpose

Menopause

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
No exercise
Sponsored by
Texas Tech University Health Sciences Center, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Menopause focused on measuring Menopause, Hot Flash, MENQOL, Mobile exercise device

Eligibility Criteria

35 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Exercise Intervention

    No Exercise

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in hot flash rate occurrence with strength training exercise.
    Hot Flash Diary, strength training manual and Fitbit flex will be used

    Secondary Outcome Measures

    Hot Flash Diary
    Measure Hot Flash duration and severity
    Menopause-Specific Quality of Life Questionnaire (MENQOL)
    Measure impact on daily life
    Calorimeter
    Measure basel metabolic rate
    FitBit Data
    Measure daily activity
    Strength training log
    Record strength training performed

    Full Information

    First Posted
    April 18, 2017
    Last Updated
    September 13, 2019
    Sponsor
    Texas Tech University Health Sciences Center, El Paso
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03236896
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    July 7, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Texas Tech University Health Sciences Center, El Paso

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menopause
    Keywords
    Menopause, Hot Flash, MENQOL, Mobile exercise device

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise Intervention
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    No Exercise
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    No exercise
    Intervention Description
    All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.
    Primary Outcome Measure Information:
    Title
    Change in hot flash rate occurrence with strength training exercise.
    Description
    Hot Flash Diary, strength training manual and Fitbit flex will be used
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Hot Flash Diary
    Description
    Measure Hot Flash duration and severity
    Time Frame
    14 weeks
    Title
    Menopause-Specific Quality of Life Questionnaire (MENQOL)
    Description
    Measure impact on daily life
    Time Frame
    14 weeks
    Title
    Calorimeter
    Description
    Measure basel metabolic rate
    Time Frame
    14 weeks
    Title
    FitBit Data
    Description
    Measure daily activity
    Time Frame
    14 weeks
    Title
    Strength training log
    Description
    Record strength training performed
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sireesha Y Reddy, MD
    Organizational Affiliation
    Texas Tech University Health Sciences Center, El Paso
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    2197954
    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.
    Results Reference
    background
    PubMed Identifier
    10694998
    Citation
    Kass-Annese B. Alternative therapies for menopause. Clin Obstet Gynecol. 2000 Mar;43(1):162-83. doi: 10.1097/00003081-200003000-00018.
    Results Reference
    background
    PubMed Identifier
    10851385
    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.
    Results Reference
    background
    PubMed Identifier
    322905
    Citation
    Campbell S, Whitehead M. Oestrogen therapy and the menopausal syndrome. Clin Obstet Gynaecol. 1977 Apr;4(1):31-47.
    Results Reference
    background
    PubMed Identifier
    8844630
    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. Erratum In: Maturitas 1996 Nov;25(3):231.
    Results Reference
    background
    PubMed Identifier
    16816054
    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.
    Results Reference
    background
    PubMed Identifier
    17881385
    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.
    Results Reference
    background
    PubMed Identifier
    8987946
    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.
    Results Reference
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