MenopauseNCT03082040
A Home-based Breathing Training on Menopausal Symptoms
A study testing home-based breathing training in people with Menopause and Menopause Related Conditions, run by Ministry of Science and Technology, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Menopause Related Conditions
- What is being tested?
- home-based breathing training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Oct 2016to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Home-based Breathing Training on Menopausal Symptoms Among Community Menopausal Women
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.
Read the detailed description
Ditto
- Conditions
- Menopause, Menopause Related Conditions
- Being tested
- home-based breathing training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based breathing trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks Receives: 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 Receives: Behavioral: home-based breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal symptoms
Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms
Measured: Baseline
Menopausal symptoms
Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms
Measured: Posttest (4 weeks from baseline)
Secondary outcomes (6)
Autonomic functions (Blood pressure)
Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure
Measured: 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
Measured: 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.
Measured: Baseline
Autonomic functions (heart rate)
Assessments using EKG sensors to detect heartbeat signals, and then be analyzed by the BioGraph Infiniti software.
Measured: 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).
Measured: 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).
Measured: Posttest (4 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start26 Oct 2016
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yuh-Kae Shyu, Ministry of Science and Technology, Taiwan
- Investigators
- Yuh-Kae Shyu, PhD, Principal investigator, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082040
- Sponsor's protocol ID
- MOST105-2314-B-030-006
- Status last verified
- Jun 2020
- First submitted
- 6 Mar 2017
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home-based Breathing Training on Menopausal Symptoms Among Community Menopausal Women
- ClinicalTrials.gov ID
- NCT03082040
- Acronym / sponsor ID
- MOST105-2314-B-030-006
- Conditions
- Menopause, Menopause Related Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ministry of Science and Technology, TaiwanOther government
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ditto
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: home-based breathing trainingThe intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks |
| waiting-list control group | Other | Behavioral: home-based breathing trainingParticipants in the control condition will conduct the same breathing training as the intervention group after a four-week waiting list period |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based breathing trainingThe 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. | Behavioural | intervention group, waiting-list control group |
Primary outcome
Menopausal symptoms
Time frame: Baseline
Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms
Menopausal symptoms
Time frame: Posttest (4 weeks from baseline)
Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms
6 secondary outcomes
Autonomic functions (Blood pressure)
Time frame: Baseline
Autonomic functions (Blood pressure)
Time frame: Posttest (4 weeks from baseline)
Autonomic functions (heart rate)
Time frame: Baseline
Autonomic functions (heart rate)
Time frame: Posttest (4 weeks from baseline)
Autonomic functions (heart rate variability)
Time frame: Baseline
Autonomic functions (heart rate variability)
Time frame: Posttest (4 weeks from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuh-Kae Shyu, PhD principal investigator
Fu Jen Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based breathing training in people with Menopause and Menopause Related Conditions, run by Ministry of Science and Technology, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopausal symptoms (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.