Studying the Impact of Exercise on Hot Flashes

Study Overview
=================
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.

Official Title
-----------------
Studying the Impact of Exercise on Hot Flashes Using Mobile Fitbit Flex, MENQOL Scale and Hot Flash Diary

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: No exercise


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Intervention<br>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. | Behavioral: Exercise<br>* 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.<br>|
| Active Comparator: No Exercise<br>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. | Behavioral: No exercise<br>* All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, Hot Flash, MENQOL, Mobile exercise device