A Home-based Breathing Training on Menopausal Symptoms

Ministry of Science and Technology, Taiwan

Status: Completed

Conditions: Menopause Related Conditions; Menopause

Treatments: Behavioral: home-based breathing training

Study type: Interventional

Funder types: Other

Identifiers

NCT03082040

MOST105-2314-B-030-006

Details and patient eligibility

About

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.

Full description

Ditto

Enrollment: 57 patients

Sex: Female

Ages: 45 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

57 participants in 2 patient groups

intervention group

Experimental group

Description:

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

Treatment:

Behavioral: home-based breathing training

waiting-list control group

Other group

Description:

Participants in the control condition will conduct the same breathing training as the intervention group after a four-week waiting list period

Treatment:

Behavioral: home-based breathing training