Studying the Impact of Exercise on Hot Flashes

NCT ID: NCT03236896

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-07-07

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.

Conditions

Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Exercise Intervention

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: 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.

No Exercise

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.

Group Type: ACTIVE_COMPARATOR

No exercise

Intervention Type: BEHAVIORAL

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

Interventions

Exercise

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.

Intervention Type: BEHAVIORAL

No exercise

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role: lead

Responsible Party

Sireesha Reddy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sireesha Y Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center, El Paso

References

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Other Identifiers

E14055

Identifier Type: -

Identifier Source: org_study_id