- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01044563
Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms
September 25, 2014 updated by: Pei-Shan Tsai, National Science Council, Taiwan
The specific aims of this study are:
- To develop a breathing training protocol specifically designed to improve HRV and psychosocial functioning for postmenopausal women with depressive symptoms,
- To examine the immediate effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms,
- To examine the intermediate-term effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms, and
- To determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in HRV.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Postmenopausal women without hormone replacement therapy are associated with higher risk of cardiac morbidity and mortality.
They are likely to experience depressive symptoms after menopause, and the comorbidity of depression are related to altered autonomic function.
We expect that postmenopausal women with depressive symptoms who receive breathing training will demonstrate decreased depressive symptoms and increased heart rate variability immediately upon and later after completion of training, and optimally contributing to improve autonomic nervous regulation in their later life to prevent undesired cardiac outcomes.
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Xinyi Dist.
-
Taipei, Xinyi Dist., Taiwan, 110
- Taipei Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Permanent termination of menstruation of natural cause.
- Cessation of menstrual cycles for more than 12 consecutive months.
- A score of the Chinese version of Beck Depression Inventory-II of greater than 10.
- Able to speak Mandarin or Taiwanese.
- Age from 45 to 64 years.
Exclusion Criteria:
- Subjects who are clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis, mental deficiency.
- Subjects who received hormone replacement therapy prescribed by gynecological physicians.
- Subjects who took cardiac and/or psychotropic medications which may affect the autonomic functions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breathing training
Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
|
Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
|
Active Comparator: Stress management
Cognitive reconstructive strategies for stress management
|
Cognitive reconstructive strategies for stress management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depressive symptoms
Time Frame: baseline
|
baseline
|
Depressive symptoms
Time Frame: posttest (8 weeks from baseline)
|
posttest (8 weeks from baseline)
|
Depressive symptoms
Time Frame: follow-up (16 weeks from baseline)
|
follow-up (16 weeks from baseline)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Time Frame: baseline
|
baseline
|
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Time Frame: posttest (8 weeks from baseline)
|
posttest (8 weeks from baseline)
|
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Time Frame: follow-up (16 weeks from baseline)
|
follow-up (16 weeks from baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
December 31, 2009
First Submitted That Met QC Criteria
January 7, 2010
First Posted (Estimate)
January 8, 2010
Study Record Updates
Last Update Posted (Estimate)
September 26, 2014
Last Update Submitted That Met QC Criteria
September 25, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSC98-2629-B-038-002-MY3-TMU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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