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Completed

NCT Number: NCT03082040

A Home-based Breathing Training on Menopausal Symptoms

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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Key information

Conditions

Menopause Menopause Related Conditions

Age range

45 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University

New Taipei City, Xinzhuang Dist, 24205, Taiwan

About this study

Ditto

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

home-based breathing training

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.

Primary outcomes

  1. Menopausal symptoms

    Time frame: Baseline

    Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms

  2. Menopausal symptoms

    Time frame: Posttest (4 weeks from baseline)

    Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms

Secondary outcomes

  1. Autonomic functions (Blood pressure)

    Time frame: Baseline

    Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure

  2. Autonomic functions (Blood pressure)

    Time frame: 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

  3. Autonomic functions (heart rate)

    Time frame: Baseline

    Assessments using EKG sensors to detect heartbeat signals, and then be analyzed by the BioGraph Infiniti software.

  4. Autonomic functions (heart rate)

    Time frame: Posttest (4 weeks from baseline)

    Assessments using EKG sensors to detect heartbeat signals, and then be analyzed by the BioGraph Infiniti software.

  5. Autonomic functions (heart rate variability)

    Time frame: 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).

  6. Autonomic functions (heart rate variability)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ministry of Science and Technology, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2017
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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