A Home-based Breathing Training on Menopausal Symptoms

Not Applicable

Completed

• Conditions: Menopause Related Conditions; Menopause
• Interventions: Behavioral: home-based breathing training

• Registration Number: NCT03082040
• Lead Sponsor: Ministry of Science and Technology, Taiwan

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

Study Timeline

• Study Start: 2016-10-26
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-11
• Study First Posted: 2017-03-17
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
intervention group	home-based breathing training	The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks
waiting-list control group	home-based breathing training	Participants in the control condition will conduct the same breathing training as the intervention group after a four-week waiting list period

Primary Outcome Measures

Name	Time	Method
Menopausal symptoms	Posttest (4 weeks from baseline)	Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms

Secondary Outcome Measures

Name	Time	Method
Autonomic functions (Blood pressure)	Posttest (4 weeks from baseline)	Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure
Autonomic functions (heart rate)	Posttest (4 weeks from baseline)	Assessments using EKG sensors to detect heartbeat signals, and then be analyzed by the BioGraph Infiniti software.
Autonomic functions (heart rate variability)	Posttest (4 weeks from baseline)	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).

Trial Locations

Locations (1)

Fu Jen Catholic University; 🇨🇳 New Taipei City, Xinzhuang Dist, Taiwan