Clinical trial NCT03082040: A Home-based Breathing Training on Menopausal Symptoms
Official title: Effects of a Home-based Breathing Training on Menopausal Symptoms Among Community Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Menopause Related Conditions
Lead sponsor: Ministry of Science and Technology, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-03-17
Enrollment: 57
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a prospective, triple-blinded and randomized controlled trial examining the effects of a home-based breathing training assisted with biofeedback on menopausal symptoms and autonomic functions among community menopausal women. We also examines whether the changes in autonomic functions would be mediators between slow breathing and menopausal symptoms. This study will include menopausal women, aged from 45 to 64, who experienced menopausal symptoms. Participants will be randomly assigned to either an intervention group (n = 80) or a waiting-list control group (n = 80). The intervention group will undergo the home-based breathing training 20 minutes twice daily and participants in the control condition will participate the same breathing training after a four-week waiting list period. The primary outcome measures are menopausal symptoms measured by symptom diaries of menopausal symptoms and the Greene Climacteric Scale (GCS). Secondary outcome measures are autonomic functions expressed by blood pressure (BP), heart rate (HR) and heart rate variability (HRV). Measurements will be taken at baseline, week 4, and week 8.

Detailed description: Ditto

Eligibility criteria: Inclusion Criteria:

* aged from 45 to 64, reporting cessation of menstrual cycles with natural causes ≧ 12 consecutive months
* the Greene Climacteric Scale (GCS) Chinese version scores ≧ 1

Exclusion Criteria:

* clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis or mental deficiency
* received hormone replacement therapy prescribed by gynecological physicians
* took cardiac medications which may affect the autonomic functions, ex., β-blockers, etc.

Primary outcomes:
measure: Menopausal symptoms
timeFrame: Baseline
measure: Menopausal symptoms
timeFrame: Posttest (4 weeks from baseline)
Secondary outcomes:
measure: Autonomic functions (Blood pressure)
timeFrame: Baseline
measure: Autonomic functions (Blood pressure)
timeFrame: Posttest (4 weeks from baseline)
measure: Autonomic functions (heart rate)
timeFrame: Baseline
measure: Autonomic functions (heart rate)
timeFrame: Posttest (4 weeks from baseline)
measure: Autonomic functions (heart rate variability)
timeFrame: Baseline
measure: Autonomic functions (heart rate variability)
timeFrame: Posttest (4 weeks from baseline)
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University
state: Xinzhuang Dist
Study officials:
affiliation: Fu Jen Catholic University
name: Yuh-Kae Shyu, PhD
role: PRINCIPAL_INVESTIGATOR
References: