Skip to main content
OpenTrials
Completed

NCT Number: NCT01034098

Ventilatory Constraint, Breathing Pattern and Ventilatory Responses in Obese Postmenopausal Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–69 year

Sex eligibility

Female

Study type

Observational

Primary location

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dynamic lung volume: end-expiratory lung volume (EELV), end-inspiratory lung volume (EILV)

    Time frame: At least 1 year post-menopause

Secondary outcomes

  1. Pulmonary function

    Time frame: At least 1 year post-menopause

  2. Breathing pattern

    Time frame: At least 1 year post-menopause

  3. Ventilatory response

    Time frame: At least 1 year post-menopause

  4. Visual analog scale (VAS) for dyspnea and leg fatigue

    Time frame: At least 1 year post-menopause

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 17, 2009
Registry last updated
Dec 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.