- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01034098
Ventilatory Constraint, Breathing Pattern and Ventilatory Responses in Obese Postmenopausal Women
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Taipei, Taiwan
- School and Graduate Institute of Physical Therapy, National Taiwan University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Postmenopausal women (for at least 1 year)
- Age below 69 y/o
- Not receiving hormone replacement therapy
Exclusion Criteria:
- Cardiopulmonary disease
- Musculoskeletal disease affecting results of maximal exercise test
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Post-menopausal women
Post-menopausal women (without hormone replacement therapy)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Dynamic lung volume: end-expiratory lung volume (EELV), end-inspiratory lung volume (EILV)
Tidsramme: At least 1 year post-menopause
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At least 1 year post-menopause
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Pulmonary function
Tidsramme: At least 1 year post-menopause
|
At least 1 year post-menopause
|
Breathing pattern
Tidsramme: At least 1 year post-menopause
|
At least 1 year post-menopause
|
Ventilatory response
Tidsramme: At least 1 year post-menopause
|
At least 1 year post-menopause
|
Visual analog scale (VAS) for dyspnea and leg fatigue
Tidsramme: At least 1 year post-menopause
|
At least 1 year post-menopause
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Li-Ying Wang, Ph.D., School and Graduate Institute of Physical Therapy, National Taiwan University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9461701144
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