A Home-based Breathing Training on Menopausal Symptoms

NCT03082040 | Completed

• 1 other identifier: MOST105-2314-B-030-006
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Menopause Related Conditions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Autonomic functions (Blood pressure)

  Baseline

• Autonomic functions (Blood pressure)

  Posttest (4 weeks from baseline)

• Autonomic functions (heart rate)

  Baseline

• Autonomic functions (heart rate)

  Posttest (4 weeks from baseline)

• Autonomic functions (heart rate variability)

  Baseline

Study Arms (2)

intervention group

EXPERIMENTAL

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

Behavioral: home-based breathing training

waiting-list control group

OTHER

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

Interventions

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.

intervention group; waiting-list control group

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Science and Technology, Taiwan: lead

Study Sites (1)

Fu Jen Catholic University

New Taipei City, Xinzhuang Dist, 24205, Taiwan

Location

Study Officials

• Yuh-Kae Shyu, PhD

  Fu Jen Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 17, 2017
• Study Start: October 26, 2016
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)