Studying the Impact of Exercise on Hot Flashes

NCT03236896 | Completed

• 1 other identifier: E14055
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menopause

Keywords

Menopause; Hot Flash; MENQOL; Mobile exercise device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hot Flash Diary

  14 weeks

• Menopause-Specific Quality of Life Questionnaire (MENQOL)

  14 weeks

• Calorimeter

  14 weeks

• FitBit Data

  14 weeks

• Strength training log

  12 weeks

Study Arms (2)

Exercise Intervention

ACTIVE COMPARATOR

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

No Exercise

ACTIVE COMPARATOR

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

Interventions

Exercise BEHAVIORAL

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.

Exercise Intervention

No exercise BEHAVIORAL

All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.

No Exercise

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Related Publications (8)

• 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 BACKGROUND

• Kass-Annese B. Alternative therapies for menopause. Clin Obstet Gynecol. 2000 Mar;43(1):162-83. doi: 10.1097/00003081-200003000-00018.

  PMID: 10694998 BACKGROUND

• 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 BACKGROUND

• Campbell S, Whitehead M. Oestrogen therapy and the menopausal syndrome. Clin Obstet Gynaecol. 1977 Apr;4(1):31-47.

  PMID: 322905 BACKGROUND

• 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.

  PMID: 8844630 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hot Flashes

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sireesha Y Reddy, MD

  Texas Tech University Health Sciences Center, El Paso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: August 2, 2017
• Study Start: October 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: July 7, 2017
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share