Studying the Impact of Exercise on Hot Flashes
Condition: Menopause
MeSH terms: Hot Flashes
Study type: Interventional

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.
    

Intervention name(s): Exercise; No exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Menopause; Hot Flash; MENQOL; Mobile exercise device