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Trial record 3 of 3 for:    8283197 [PUBMED-IDS]

EMPOWER-PULM (PULMonary Outcomes in Older Adults Empowered With Movement to Prevent Obesity and Weight Regain) (EMPOWER-PULM)

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ClinicalTrials.gov Identifier: NCT03621098
Recruitment Status : Completed
First Posted : August 8, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease
Obesity Pulmonary Disease Dyspnea

Detailed Description:
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)

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: EMPOWER-PULM (PULMonary Outcomes in Older Adults Empowered With Movement to Prevent Obesity and Weight Regain)
Actual Study Start Date : December 15, 2016
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018

Group/Cohort
Diet+Exercise
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+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+Exercise+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)



Primary Outcome Measures :
  1. 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 Pulmonary Function

  2. Number of patients who are able to undergo respiratory muscle strength testing [ Time Frame: Month 6 (end of study) ]
    Number of patients who are able to undergo respiratory muscle strength testing

  3. Participant retention [ Time Frame: Month 6 (end of study) ]
    Measured by the number of participants who return for the 6 month testing

  4. Assess FEV1 on pulmonary function testing for breathlessness [ Time Frame: Month 6 (end of study) ]
    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.

  5. Assess FVC on pulmonary function testing for breathlessness [ Time Frame: Month 6 (end of study) ]
    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.

  6. Lung volumes [ Time Frame: Month 6 (end of study) ]
    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

  7. Diffusing capacity [ Time Frame: Month 6 (end of study) ]
    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).

  8. Respiratory muscle strength [ Time Frame: Month 6 (end of study) ]
    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.

  9. Six minute walk distance [ Time Frame: Month 6 (end of study) ]
    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

  10. Dyspnea scores based on mMRC (Modified Medical Research Council) [ Time Frame: Month 6 (end of study) ]
    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.

  11. Dyspnea scores based on USCD SOBQ (University of California Shortness of Breath Questionnaire) [ Time Frame: Month 6 (end of study) ]
    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.



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Current participants in the parent study, EMPOWER (Empowered with Movement to Prevent Obesity and Weight Regain)
Criteria

Inclusion Criteria:

  • 65 -85 years of age
  • BMI = 30-45 kg/m2
  • Weight stable - no loss or gain (±5%) in past 6 months
  • Sedentary
  • No contraindication for safe and optimal participation in exercise training
  • Approved for participation by Medical Director

Exclusion Criteria:

  • Dependent on cane or walker
  • Reported unintentional or intentional weight loss or gain of >5% in past 6 months
  • Participation in regular resistance training and/or > 20 mins/day of aerobic exercise in past 6 months
  • Osteroporosis (t-score <2.3 on hip or spine scan); Severe arthritis, or other musculoskeletal disorder; Joint replacement or other orthopedic surgery in past 6 mos; joint replacement or other orthopedic surgery planned in next 2 years
  • Uncontrolled resting hypertension (>160/90 mmHg);
  • Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease,; cancer requiring treatment in past year, except non-melanoma skin cancers
  • Serious conduction disorder, new Q waves or ST-segment depression (>3mm), or uncontrolled arrhythmia
  • Room air SpO2 (oxygen saturation) at rest or with exercise qualifying for supplementary oxygen (SpO2≤88%)
  • Abnormal kidney or liver function (2x upper limit of normal);
  • eFGR < mL/min/1.73m2
  • Anemia (Hb<14 g/dl in men/<12.3 g/dL in women);
  • Uncontrolled diabetes (fasting blood glucose > 140 mg/dl);
  • Deficient levels of vitamin D (25 hydroxyvitamin D level <20mg/mL) in those not taking a vitamin D supplement
  • Smoker (No nicotine in past yr)
  • No heavy alcohol use (>14 drinks/week)
  • Unstable severe depression
  • Regular use of: growth hormones, oral steroids, weight loss medications* or prescription osteoporosis medications*
  • Current participation in other research study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621098


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Barbara J Nicklas, PhD Wake Forest University Health Sciences

Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03621098     History of Changes
Other Study ID Numbers: IRB00041663
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Exercise
Additional relevant MeSH terms:
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Dyspnea
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory