A Home-based Breathing Training on Menopausal Symptoms

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082040
• Other study ID #: MOST105-2314-B-030-006
• Status: Completed
• Phase: N/A
• Start date: October 26, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: June 2020
• Source: Ministry of Science and Technology, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Ditto

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 64 Years

Eligibility

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., ß-blockers, etc.

Related Conditions & MeSH terms

• Menopause
• Menopause Related Conditions

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University	New Taipei City	Xinzhuang Dist

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopausal symptoms	Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms	Baseline
Primary	Menopausal symptoms	Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms	Posttest (4 weeks from baseline)
Secondary	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
Secondary	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)
Secondary	Autonomic functions (heart rate)	Assessments using EKG sensors to detect heartbeat signals, and then be analyzed by the BioGraph Infiniti software.	Baseline
Secondary	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)
Secondary	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
Secondary	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)