A Home-based Breathing Training on Menopausal Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-26

Study Completion Date

2017-12-20

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.

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Detailed Description

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Ditto

Conditions

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Menopause Menopause Related Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intervention group

The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks

Group Type EXPERIMENTAL

home-based breathing training

Intervention Type BEHAVIORAL

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.

waiting-list control group

Participants in the control condition will conduct the same breathing training as the intervention group after a four-week waiting list period

Group Type OTHER

home-based breathing training

Intervention Type BEHAVIORAL

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.

Interventions

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home-based breathing training

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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes