A Home-based Breathing Training on Menopausal Symptoms

Study Overview
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Brief Summary
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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
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Ditto

Official Title
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Effects of a Home-based Breathing Training on Menopausal Symptoms Among Community Menopausal Women

Conditions
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Menopause, Menopause Related Conditions

Intervention / Treatment
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* Behavioral: home-based breathing training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks | Behavioral: home-based breathing training<br>* The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks. Participants in the control condition will participate the same breathing training after a four-week waiting list period.<br>|
| Other: waiting-list control group<br>Participants in the control condition will conduct the same breathing training as the intervention group after a four-week waiting list period | Behavioral: home-based breathing training<br>* The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks. Participants in the control condition will participate the same breathing training after a four-week waiting list period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopausal symptoms | Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms | Baseline | 
| Menopausal symptoms | Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms | Posttest (4 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic functions (Blood pressure) | Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure | Baseline | 
| Autonomic functions (Blood pressure) | Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure | Posttest (4 weeks from baseline) | 
| Autonomic functions (heart rate) | Assessments using EKG sensors to detect heartbeat signals, and then be analyzed by the BioGraph Infiniti software. | Baseline | 
| Autonomic functions (heart rate) | Assessments using EKG sensors to detect heartbeat signals, and then be analyzed by the BioGraph Infiniti software. | Posttest (4 weeks from baseline) | 
| Autonomic functions (heart rate variability) | A 3-lead EKG and Cardiopro Software were used to assess and analyze the heart rate variability in time domain, including SDNN (standard deviation of all NN intervals), rMSSD (the root mean square successive difference of normal-to-normal intervals) and pNN50 (NN50 count divided by the total number of all NN intervals). | Baseline | 
| Autonomic functions (heart rate variability) | A 3-lead EKG and Cardiopro Software were used to assess and analyze the heart rate variability in time domain, including SDNN (standard deviation of all NN intervals), rMSSD (the root mean square successive difference of normal-to-normal intervals) and pNN50 (NN50 count divided by the total number of all NN intervals). | Posttest (4 weeks from baseline) |