An interventional study of home-based breathing training in Menopause and Menopause Related Conditions, sponsored by Ministry of Science and Technology, Taiwan. Completed at 1 site in Taiwan. Open to female participants aged 45 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by Ministry of Science and Technology, Taiwan · Not applicable, Interventional, and Treatment
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.
Ditto
Exclusion Criteria:
The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks
Behavioral: 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
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.
Menopausal symptoms
Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms
Time frame: Baseline
Menopausal symptoms
Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms
Time frame: Posttest (4 weeks from baseline)
Autonomic functions (Blood pressure)
Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure
Time frame: Baseline
Autonomic functions (Blood pressure)
Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure
Time frame: Posttest (4 weeks from baseline)
Autonomic functions (heart rate)
Assessments using EKG sensors to detect heartbeat signals, and then be analyzed by the BioGraph Infiniti software.
Time frame: Baseline
Autonomic functions (heart rate)
Assessments using EKG sensors to detect heartbeat signals, and then be analyzed by the BioGraph Infiniti software.
Time frame: Posttest (4 weeks from baseline)
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).
Time frame: Baseline
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).
Time frame: Posttest (4 weeks from baseline)
Plan to share: No
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Ministry of Science and Technology, Taiwan