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

Completed

Conditions studied: Obesity, Pulmonary Disease, Dyspnea

In brief

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.

Key facts

Study ID

NCT03621098

Run by

Wake Forest University Health Sciences

People needed

76

Starts

2016-12-15

Expected to finish

2018-11-19

Last updated by the study team

2019-06-06

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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