ObesityNCT01034098
Ventilatory Constraint, Breathing Pattern and Ventilatory Responses in Obese Postmenopausal Women
An observational study of Obesity and Postmenopausal Women, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study was to examine the dynamic lung volumes in obese post-menopausal women (without hormone replacement therapy) during exercise and their correlations with dyspnea. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Postmenopausal Women
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2005to Apr 2007
- Phase
- Observational
- 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 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women (for at least 1 year) who aged below 69 y/o without hormone replacement therapy
Who may be able to join
- Postmenopausal women (for at least 1 year)
- Age below 69 y/o
- Not receiving hormone replacement therapy
Who cannot join
- Cardiopulmonary disease
- Musculoskeletal disease affecting results of maximal exercise test
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy, National Taiwan University
Taipei
About this study
The purpose of this study was to examine the dynamic lung volumes in obese post-menopausal women (without hormone replacement therapy) during exercise and their correlations with dyspnea.
Read the detailed description
Obesity-related changes in lung volumes have shown to affect breathing mechanisms. During exercise, altered breathing mechanisms increase potential for expiratory flow limitation and compromise exercise capacity. Estrogen and progesterone are potent respiratory stimulants, and their effects in the physiologic regulation of breathing are down-regulated after menopause. Therefore, we theorized that the combined obesity and reduced sex hormone levels after menopause work as a double jeopardy to cause mechanical ventilatory constraint which aggravates dyspnea sensation during exercise, and thus a reduction in exercise capacity. The purpose of this study was to exam the dynamic lung volumes in obese post-menopausal women (without hormone replacement therapy) during exercise and their correlations with dyspnea.
From doctoral referral and advertisement, 24 obese (BMI ≧ 27 kg/m2) and 26 lean post-menopausal women were recruited for the study. Pulmonary function and body composition were measured at rest. A maximal flow volume loop (MFVL) was obtained at baseline. All subjects then performed an incremental exercise test on a cycle ergometer with workload increasing 25 watts every 3 min. During exercise, at each workload, the tidal exercise FV loops were obtained and an inspiratory capacity (IC) maneuver was conducted to assess changes in end-expiratory lung volume (EELV) and end inspiratory lung volume (EILV). Dyspnea and leg fatigue were assessed using the Borg scale. Analysis of variance with repeated measurements was used to test the significance of the mean differences between the two groups during exercise. Linear regression analysis was used to determine whether changes in dynamic lung volumes during exercise were related to changes in Borg scores. Statistical significance was established at p<0.05.
- Conditions
- Obesity, Postmenopausal Women
- Keywords
- Obesity, Postmenopausal women, Mechanical ventilatory constraints, Dynamic lung volume, Expiratory flow limitation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-menopausal women | Post-menopausal women (without hormone replacement therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic lung volume: end-expiratory lung volume (EELV), end-inspiratory lung volume (EILV)
Measured: At least 1 year post-menopause
Secondary outcomes (4)
Pulmonary function
Measured: At least 1 year post-menopause
Breathing pattern
Measured: At least 1 year post-menopause
Ventilatory response
Measured: At least 1 year post-menopause
Visual analog scale (VAS) for dyspnea and leg fatigue
Measured: At least 1 year post-menopause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startDec 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Li-Ying Wang, Ph.D., Principal investigator, School and Graduate Institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034098
- Sponsor's protocol ID
- 9461701144
- Status last verified
- Dec 2009
- First submitted
- 16 Dec 2009
- Last updated
- 17 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Constraint, Breathing Pattern and Ventilatory Responses in Obese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01034098
- Acronym / sponsor ID
- 9461701144
- Conditions
- Obesity, Postmenopausal Women
- Keywords
- Obesity, Postmenopausal women, Mechanical ventilatory constraints, Dynamic lung volume, Expiratory flow limitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 17 Dec 2009 (estimated)
- 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.
The purpose of this study was to examine the dynamic lung volumes in obese post-menopausal women (without hormone replacement therapy) during exercise and their correlations with dyspnea.
Detailed description
Obesity-related changes in lung volumes have shown to affect breathing mechanisms. During exercise, altered breathing mechanisms increase potential for expiratory flow limitation and compromise exercise capacity. Estrogen and progesterone are potent respiratory stimulants, and their effects in the physiologic regulation of breathing are down-regulated after menopause. Therefore, we theorized that the combined obesity and reduced sex hormone levels after menopause work as a double jeopardy to cause mechanical ventilatory constraint which aggravates dyspnea sensation during exercise, and thus a reduction in exercise capacity. The purpose of this study was to exam the dynamic lung volumes in obese post-menopausal women (without hormone replacement therapy) during exercise and their correlations with dyspnea.
From doctoral referral and advertisement, 24 obese (BMI ≧ 27 kg/m2) and 26 lean post-menopausal women were recruited for the study. Pulmonary function and body composition were measured at rest. A maximal flow volume loop (MFVL) was obtained at baseline. All subjects then performed an incremental exercise test on a cycle ergometer with workload increasing 25 watts every 3 min. During exercise, at each workload, the tidal exercise FV loops were obtained and an inspiratory capacity (IC) maneuver was conducted to assess changes in end-expiratory lung volume (EELV) and end inspiratory lung volume (EILV). Dyspnea and leg fatigue were assessed using the Borg scale. Analysis of variance with repeated measurements was used to test the significance of the mean differences between the two groups during exercise. Linear regression analysis was used to determine whether changes in dynamic lung volumes during exercise were related to changes in Borg scores. Statistical significance was established at p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-menopausal women | – | –Post-menopausal women (without hormone replacement therapy) |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women (for at least 1 year) who aged below 69 y/o without hormone replacement therapy
Key inclusion criteria (3 listed)
- Postmenopausal women (for at least 1 year)
- Age below 69 y/o
- Not receiving hormone replacement therapy
Key exclusion criteria (2 listed)
- Cardiopulmonary disease
- Musculoskeletal disease affecting results of maximal exercise test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic lung volume: end-expiratory lung volume (EELV), end-inspiratory lung volume (EILV)
Time frame: At least 1 year post-menopause
4 secondary outcomes
Pulmonary function
Time frame: At least 1 year post-menopause
Breathing pattern
Time frame: At least 1 year post-menopause
Ventilatory response
Time frame: At least 1 year post-menopause
Visual analog scale (VAS) for dyspnea and leg fatigue
Time frame: At least 1 year post-menopause
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 17 Dec 2009.
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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.
Li-Ying Wang, Ph.D. principal investigator
School and Graduate Institute of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Postmenopausal Women, run by National Taiwan University Hospital 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 3 inclusion and 2 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 17 Dec 2009. 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?
Dynamic lung volume: end-expiratory lung volume (EELV), end-inspiratory lung volume (EILV) (time frame: At least 1 year post-menopause). 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 17 Dec 2009.