<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03236896</url>
  </required_header>
  <id_info>
    <org_study_id>E14055</org_study_id>
    <nct_id>NCT03236896</nct_id>
  </id_info>
  <brief_title>Studying the Impact of Exercise on Hot Flashes</brief_title>
  <official_title>Studying the Impact of Exercise on Hot Flashes Using Mobile Fitbit Flex, MENQOL Scale and Hot Flash Diary</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center, El Paso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Tech University Health Sciences Center, El Paso</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective randomized pragmatic trial will be used to obtain data on energy expenditure,&#xD;
      temperature changes and vasomotor symptoms at baseline, during the intervention in which&#xD;
      participants will be randomized to either exercise or to not exercise, and at the end of the&#xD;
      12-week intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During menopause, the main symptom that prompts women to seek medical attention is hot&#xD;
      flashes. It is estimated that 75% of all menopausal women (approximately 50,000,000) will&#xD;
      experience hot flashes, and that 15% will be severely affected. In addition to hot flashes,&#xD;
      other significant climacteric symptoms include depression, insomnia, nervousness, fatigue,&#xD;
      arthralgia, headache, vaginal dryness and night sweats. Most clinical trials assessing&#xD;
      therapeutic efficacy use subjective reports (eg. questionnaires, diaries). The current gold&#xD;
      standard for objective assessment of hot flashes is measuring the skin conductance level.&#xD;
      However, there is still a relative discordancy between self reported and objectively detected&#xD;
      hot flashes even with the use of skin conductance level. A combination of objective and&#xD;
      subjective measures probably constitutes a valid assessment of vasomotor symptoms.&#xD;
&#xD;
      The menopausal transition is associated with a risk to increase in body weight and adiposity.&#xD;
      Weight gain in the menopausal woman can be closely associated with aging but is also&#xD;
      influenced by hormonal changes. Identifying modifiable factors that can prevent or attenuate&#xD;
      theses changes is of great relevance. Resting energy expenditure decreases with age but also&#xD;
      decreases with loss of ovarian function. There is little data on energy expenditure as it&#xD;
      relates to the menopause and how influences such as exercise play a role in metabolic rate&#xD;
      and how this may play a role in vasomotor symptoms. is an a portable monitor that will be&#xD;
      used to collect minute by minute data on energy expenditure, physical activity and sleep&#xD;
      monitoring. This data will be used to calculate temperature regulation. There are no studies&#xD;
      using this device on women undergoing the menopause transition. Given the skin temperature&#xD;
      fluxes that occur with hot flashes, it is possible that energy expenditure is not calculated&#xD;
      correctly, since heat is used as a measure of energy expenditure. There are also no studies&#xD;
      comparing this device to the current subjective evaluative methods like the hot flash diary&#xD;
      and quality of life surveys. The purpose of this study is to generate preliminary data needed&#xD;
      to conduct a larger trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">July 7, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in hot flash rate occurrence with strength training exercise.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Hot Flash Diary, strength training manual and Fitbit flex will be used</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hot Flash Diary</measure>
    <time_frame>14 weeks</time_frame>
    <description>Measure Hot Flash duration and severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menopause-Specific Quality of Life Questionnaire (MENQOL)</measure>
    <time_frame>14 weeks</time_frame>
    <description>Measure impact on daily life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calorimeter</measure>
    <time_frame>14 weeks</time_frame>
    <description>Measure basel metabolic rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FitBit Data</measure>
    <time_frame>14 weeks</time_frame>
    <description>Measure daily activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength training log</measure>
    <time_frame>12 weeks</time_frame>
    <description>Record strength training performed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Menopause</condition>
  <arm_group>
    <arm_group_label>Exercise Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <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.</description>
    <arm_group_label>Exercise Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No exercise</intervention_name>
    <description>All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.</description>
    <arm_group_label>No Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects will be women&#xD;
&#xD;
          -  All subjects will be between the ages of 35 and 60&#xD;
&#xD;
          -  Must experience 7-20, moderate-severe hot flashes/day or 50-140, moderate-severe hot&#xD;
             flashes/week for greater than two months. Moderate or severe hot flashes are recurrent&#xD;
             periods of heat sensation and sweating that either do not interfere with or cause the&#xD;
             cessation of an activity, respectively&#xD;
&#xD;
          -  Must have had a bilateral salpingo-oophorectomy for &gt;12 months or amenorrhea &gt;12&#xD;
             months&#xD;
&#xD;
          -  Must have a signed informed consent&#xD;
&#xD;
          -  Must be able to function independently in all activities of daily living and be&#xD;
             capable of reliable documentation for at least six consecutive weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men and children will not be included.&#xD;
&#xD;
          -  Have current history of fever, cough, dysuria or diarrhea (i.e., signs of infection).&#xD;
&#xD;
          -  Have &gt;10% of hot flashes predictably related to certain food ingestion alcohol intake.&#xD;
&#xD;
          -  Have a history of &quot;easily blushing&quot; and have &gt;10% hot flashes associated with&#xD;
             embarrassing events or migraines.&#xD;
&#xD;
          -  Have an MI, stroke, functional decline within 1 month.&#xD;
&#xD;
          -  Have a history of somatoform disorder.&#xD;
&#xD;
          -  Have an estimated creatinine clearance &lt; 60ml/min.&#xD;
&#xD;
          -  Fail to record data in the diary for &gt;3 days during the 2 week baseline period.&#xD;
&#xD;
          -  Unable or unwilling to make weekly visits over course of therapy&#xD;
&#xD;
          -  Received any calcium channel antagonists or gabapentin for the past two weeks.&#xD;
             Received estrogen, herbal estrogen, progestin, leuprolide acetate or tamoxifen within&#xD;
             the past two months (if they would still like to participate, they will be required to&#xD;
             undergo a 2 month washout period before enrolling in the study). Started clonidine,&#xD;
             raloxifene or a new anti-depressant within the past month.&#xD;
&#xD;
          -  Any contraindications to exercise or inability to exercise.&#xD;
&#xD;
          -  Specific risks to resistance testing or training: Confirmed or suspected osteoporosis&#xD;
             or osteopenia, musculo-skeletal injuries to involved joints, surgery within last year&#xD;
             (includes eye surgery), hernia, Marfan syndrome, implanted pacemaker or defibrillator,&#xD;
             low functional capacity (&lt;4 METS), uncontrolled hypertension &gt;160/100 mmHg represent a&#xD;
             partial list of risks.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sireesha Y Reddy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Tech University Health Sciences Center, El Paso</affiliation>
  </overall_official>
  <reference>
    <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>
    <PMID>2197954</PMID>
  </reference>
  <reference>
    <citation>Kass-Annese B. Alternative therapies for menopause. Clin Obstet Gynecol. 2000 Mar;43(1):162-83. doi: 10.1097/00003081-200003000-00018.</citation>
    <PMID>10694998</PMID>
  </reference>
  <reference>
    <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>
    <PMID>10851385</PMID>
  </reference>
  <reference>
    <citation>Campbell S, Whitehead M. Oestrogen therapy and the menopausal syndrome. Clin Obstet Gynaecol. 1977 Apr;4(1):31-47.</citation>
    <PMID>322905</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>8844630</PMID>
  </reference>
  <reference>
    <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>
    <PMID>16816054</PMID>
  </reference>
  <reference>
    <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>
    <PMID>17881385</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>8987946</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>April 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>September 13, 2019</last_update_submitted>
  <last_update_submitted_qc>September 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Tech University Health Sciences Center, El Paso</investigator_affiliation>
    <investigator_full_name>Sireesha Reddy</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Menopause</keyword>
  <keyword>Hot Flash</keyword>
  <keyword>MENQOL</keyword>
  <keyword>Mobile exercise device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hot Flashes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03236896
org study id: E14055
nct id: NCT03236896
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in hot flash rate occurrence with strength training exercise.
time frame: 12 weeks
description: Hot Flash Diary, strength training manual and Fitbit flex will be used
measure: Hot Flash Diary
time frame: 14 weeks
description: Measure Hot Flash duration and severity
measure: Menopause-Specific Quality of Life Questionnaire (MENQOL)
time frame: 14 weeks
description: Measure impact on daily life
measure: Calorimeter
time frame: 14 weeks
description: Measure basel metabolic rate
measure: FitBit Data
time frame: 14 weeks
description: Measure daily activity
measure: Strength training log
time frame: 12 weeks
description: Record strength training performed
arm group label: Exercise Intervention
arm group type: Active Comparator
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 group label: No Exercise
arm group type: Active Comparator
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: Exercise
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.
arm group label: Exercise Intervention
intervention type: Behavioral
intervention name: No exercise
description: All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.
arm group label: No Exercise
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sireesha Y Reddy, MD
role: Principal Investigator
affiliation: Texas Tech University Health Sciences Center, El Paso
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.
PMID: 2197954
citation: Kass-Annese B. Alternative therapies for menopause. Clin Obstet Gynecol. 2000 Mar;43(1):162-83. doi: 10.1097/00003081-200003000-00018.
PMID: 10694998
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.
PMID: 10851385
citation: Campbell S, Whitehead M. Oestrogen therapy and the menopausal syndrome. Clin Obstet Gynaecol. 1977 Apr;4(1):31-47.
PMID: 322905
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.
PMID: 8844630
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.
PMID: 16816054
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.
PMID: 17881385
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.
PMID: 8987946
responsible party type: Principal Investigator
investigator affiliation: Texas Tech University Health Sciences Center, El Paso
investigator full name: Sireesha Reddy
investigator title: Professor
mesh term: Hot Flashes
sharing ipd: No