An observational study in Obesity, Pulmonary Disease and Dyspnea, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by Wake Forest University Health Sciences · Observational
The purpose of this study is to improve the understanding of the effects of weight loss on the lungs in older adults. Different types of tests to understand the effects of the EMPOWER interventions on lung function will be administered.
This is a randomized clinical trial of the effects of structured aerobic exercise and a sedentary behavior intervention during weight loss on respiratory function. Site will enroll 150 older (65-85 years), obese (BMI=30-45 kg/m2), sedentary men and women from EMPOWER. EMPOWER is a 3-group design where participants will undergo a 9-month weight loss (WL) intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month self-managed follow-up phase with minimal contact. The diet element of the interventions is identical across groups, but groups differ by activity intervention: 1) moderate-intensity aerobic exercise (WL+EX); 2) intervening on SB (WL+SitLess); or 3) (WL+EX+SitLess)
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 76 is below the median of 132 across 1,338 observational studies indexed under Obesity.
Browse Obesity studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Current participants in the parent study, EMPOWER (Empowered with Movement to Prevent Obesity and Weight Regain)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diet with structured exercise (mostly walking) at a moderate-intensity level This is not an intervention study, however, the intervention type from the parent study (EMPOWER) was behavioral (Caloric Restriction with and without Structured Exercise or Daily Activity)
Diet with increased light-intensity physical activity and decreased sedentary behavior throughout the day. This is not an intervention study, however, the intervention type from the parent study (EMPOWER) was behavioral (Caloric Restriction with and without Structured Exercise or Daily Activity)
Diet with structured exercise and increased daily activity. This is not an intervention study, however, the intervention type from the parent study (EMPOWER) was behavioral (Caloric Restriction with and without Structured Exercise or Daily Activity)
Number of patients who are able to undergo Pulmonary Function
Number of patients who are able to undergo Pulmonary Function
Time frame: Month 6 (end of study)
Number of patients who are able to undergo respiratory muscle strength testing
Number of patients who are able to undergo respiratory muscle strength testing
Time frame: Month 6 (end of study)
Participant retention
Measured by the number of participants who return for the 6 month testing
Time frame: Month 6 (end of study)
Assess FEV1 on pulmonary function testing for breathlessness
FEV1 used to estimate treatment effect sizes on pulmonary function and physical performance.. Paired t-test analysis will be used to compare within treatment group pre-and post outcomes with adjusted analysis. ANOVA with adjusted analysis will be used to amke between group comparisons and to compare changes in outcomes between treatment groups after the 6-month intensive weight loss phase.
Time frame: Month 6 (end of study)
Assess FVC on pulmonary function testing for breathlessness
FVC used to estimate treatment effect sizes on pulmonary function and physical performance. Paired t-test analysis will be used to compare within treatment group pre- and post outcomes with adjusted analysis. ANOVA with adjusted analysis will be used to make between group comparisons and to compare changes in outcomes between treatment groups after the 6-month intensive weight loss phase.
Time frame: Month 6 (end of study)
Lung volumes
Lung volumes measures measures the volume of gas within the lungs and is considered a standard for lung volume measurements. Participants are asked to sit comfortably. They are then asked to breath through a mouthpiece that is connected to a sensor that will be recording changes in the concentration of gas washed out from the lungs with each breath taken. Scores based on mMRC (Modified Medical Research Council) dyspnea scale
Time frame: Month 6 (end of study)
Diffusing capacity
Diffusing Capacity will be measured by carbon-monoxide single-breath wash out. This test examines the alveolar uptake efficiency for carbon monoxide and therefore reflects the quality of alveolar-capillary gas uptake (how well gas diffuses through alveoli into the capillaries to get to the red blood cells).
Time frame: Month 6 (end of study)
Respiratory muscle strength
Respiratory muscle strength is assessed by measuring the maximal inspiratory the maximal expiratory pressures. The maximal inspiratory pressure reflects diaphragmatic and inspiratory muscle strength while the maximal expiratory pressure reflects abdominal muscle and expiratory muscle strength. Paired t-test analysis will be used to compare within treatment group pre- and post outcomes with adjusted analysis. ANOVA with adjusted analysis will be used to make between group comparisons and to compare changes in outcomes between treatment groups after the 6-month intensive weight loss phase.
Time frame: Month 6 (end of study)
Six minute walk distance
The 6-minute walk test s a validated test in chronic respiratory disease. It is self-paced of walking capacity and participants are encouraged to cover as much distance as they can in within 6 minutes. The 6-minute walk distance will be measured which is strongly associated with clinical outcomes. Pulse oximetry will be continuously measured
Time frame: Month 6 (end of study)
Dyspnea scores based on mMRC (Modified Medical Research Council)
The mMRC is a 1 question, five-item instrument to assess a patient's degree of breathlessness in relation to physical activity. Participants are given a brief description of an activity and then are asked to select the statement that best describes their experience with dyspnea. The score on the mMRC is weighted on a 0-4 scale and quantifies disability and exercise limitation associated with breathlessness.
Time frame: Month 6 (end of study)
Dyspnea scores based on USCD SOBQ (University of California Shortness of Breath Questionnaire)
SOBQ is a 24-item questionnaire; 21 items assess severity of breathlessness during specific activities of daily living and 3 items assess limitations due to shortness of breath, fear of harm from overexertion, and fear of shortness of breath. Each item is weighted on a 0-5 scale, and are totaled for a final score of 0-120 with high scores indicating increased severity with performing activities.
Time frame: Month 6 (end of study)
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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