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

Completed

• Conditions: Obesity; Pulmonary Disease; Dyspnea

• Registration Number: NCT03621098
• Lead Sponsor: 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.

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)

Study Timeline

• Study Start: 2016-12-15
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-08
• Primary Completion: 2018-11-19
• Study Completion: 2018-11-19
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant retention	Month 6 (end of study)	Measured by the number of participants who return for the 6 month testing
Assess FVC on pulmonary function testing for breathlessness	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.
Dyspnea scores based on USCD SOBQ (University of California Shortness of Breath Questionnaire)	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.
Number of patients who are able to undergo Pulmonary Function	Month 6 (end of study)	Number of patients who are able to undergo Pulmonary Function
Number of patients who are able to undergo respiratory muscle strength testing	Month 6 (end of study)	Number of patients who are able to undergo respiratory muscle strength testing
Assess FEV1 on pulmonary function testing for breathlessness	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.
Lung volumes	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
Dyspnea scores based on mMRC (Modified Medical Research Council)	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.
Diffusing capacity	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).
Respiratory muscle strength	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.
Six minute walk distance	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

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States