A Home-based Breathing Training on Menopausal Symptoms

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

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.

Study Overview

• Status: Completed
• Conditions: Menopause; Menopause Related Conditions
• Intervention / Treatment: Behavioral: home-based breathing training

Detailed Description

Ditto

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Xinzhuang Dist
    • New Taipei City, Xinzhuang Dist, Taiwan, 24205
      • Fu Jen Catholic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intervention group; The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks	Behavioral: 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.
OTHER: 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	Behavioral: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Yuh-Kae Shyu, PhD, Fu Jen Catholic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 26, 2016
• Primary Completion (ACTUAL): December 20, 2017
• Study Completion (ACTUAL): December 20, 2017

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 11, 2017
• First Posted (ACTUAL): March 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MOST105-2314-B-030-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No