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



Status:Recruiting
Conditions:Obesity Weight Loss, Pulmonary, Pulmonary
Therapuetic Areas:Endocrinology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:65 - 85
Updated:8/10/2018
Start Date:December 15, 2016
End Date:June 1, 2019
Contact:Maria Opina, MD
Email:mopina@wakehealth.edu
Phone:(336) 716-8886

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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)

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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Barbara J Nicklas, PhD
Phone: 336-716-8886
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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