Status:
COMPLETED
Studying the Impact of Exercise on Hot Flashes
Lead Sponsor:
Texas Tech University Health Sciences Center, El Paso
Conditions:
Menopause
Eligibility:
FEMALE
35-60 years
Phase:
NA
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 b...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03236896
Start Date
October 1 2015
End Date
July 7 2017
Last Update
September 16 2019
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