ObesityEMPOWER-PULMNCT03621098
EMPOWER-PULM (PULMonary Outcomes in Older Adults Empowered With Movement to Prevent Obesity and Weight Regain)
An observational study of Obesity and Pulmonary Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Obesity, Pulmonary Disease, Dyspnea
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2016to 19 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Current participants in the parent study, EMPOWER (Empowered with Movement to Prevent Obesity and Weight Regain)
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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)
- Conditions
- Obesity, Pulmonary Disease, Dyspnea
- Keywords
- Exercise
- Medical subject headings
- Obesity, Lung Diseases, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who are able to undergo Pulmonary Function
Number of patients who are able to undergo Pulmonary Function
Measured: 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
Measured: Month 6 (end of study)
Participant retention
Measured by the number of participants who return for the 6 month testing
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Month 6 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Dec 2016
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara J Nicklas, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621098
- Sponsor's protocol ID
- IRB00041663
- Acronym
- EMPOWER-PULM
- Status last verified
- Jun 2019
- First submitted
- 1 Aug 2018
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lazarus R, Sparrow D, Weiss ST. Effects of obesity and fat distribution on ventilatory function: the normative aging study. Chest. 1997 Apr;111(4):891-8. doi: 10.1378/chest.111.4.891.
PubMed 9106566Jones RL, Nzekwu MM. The effects of body mass index on lung volumes. Chest. 2006 Sep;130(3):827-33. doi: 10.1378/chest.130.3.827.
PubMed 16963682Babb TG, Ranasinghe KG, Comeau LA, Semon TL, Schwartz B. Dyspnea on exertion in obese women: association with an increased oxygen cost of breathing. Am J Respir Crit Care Med. 2008 Jul 15;178(2):116-23. doi: 10.1164/rccm.200706-875OC. Epub 2008 Apr 17.
PubMed 18420968Salome CM, Munoz PA, Berend N, Thorpe CW, Schachter LM, King GG. Effect of obesity on breathlessness and airway responsiveness to methacholine in non-asthmatic subjects. Int J Obes (Lond). 2008 Mar;32(3):502-9. doi: 10.1038/sj.ijo.0803752. Epub 2007 Oct 23.
PubMed 17955030Sharma G, Goodwin J. Effect of aging on respiratory system physiology and immunology. Clin Interv Aging. 2006;1(3):253-60. doi: 10.2147/ciia.2006.1.3.253.
PubMed 18046878Rossi A, Fantin F, Di Francesco V, Guariento S, Giuliano K, Fontana G, Micciolo R, Solerte SB, Bosello O, Zamboni M. Body composition and pulmonary function in the elderly: a 7-year longitudinal study. Int J Obes (Lond). 2008 Sep;32(9):1423-30. doi: 10.1038/ijo.2008.103. Epub 2008 Jul 22.
PubMed 18645577Rossi AP, Watson NL, Newman AB, Harris TB, Kritchevsky SB, Bauer DC, Satterfield S, Goodpaster BH, Zamboni M. Effects of body composition and adipose tissue distribution on respiratory function in elderly men and women: the health, aging, and body composition study. J Gerontol A Biol Sci Med Sci. 2011 Jul;66(7):801-8. doi: 10.1093/gerona/glr059. Epub 2011 Apr 15.
PubMed 21498841Alley DE, Chang VW. The changing relationship of obesity and disability, 1988-2004. JAMA. 2007 Nov 7;298(17):2020-7. doi: 10.1001/jama.298.17.2020.
PubMed 17986695Vasquez E, Batsis JA, Germain CM, Shaw BA. Impact of obesity and physical activity on functional outcomes in the elderly: data from NHANES 2005-2010. J Aging Health. 2014 Sep;26(6):1032-46. doi: 10.1177/0898264314535635. Epub 2014 Jun 9.
PubMed 24913317American College of Cardiology/American Heart Association Task Force on Practice Guidelines, Obesity Expert Panel, 2013. Executive summary: Guidelines (2013) for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society published by the Obesity Society and American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Based on a systematic review from the The Obesity Expert Panel, 2013. Obesity (Silver Spring). 2014 Jul;22 Suppl 2:S5-39. doi: 10.1002/oby.20821. No abstract available.
PubMed 24961825Wei YF, Tseng WK, Huang CK, Tai CM, Hsuan CF, Wu HD. Surgically induced weight loss, including reduction in waist circumference, is associated with improved pulmonary function in obese patients. Surg Obes Relat Dis. 2011 Sep-Oct;7(5):599-604. doi: 10.1016/j.soard.2011.04.221. Epub 2011 Apr 19.
PubMed 21689991Karason K, Lindroos AK, Stenlof K, Sjostrom L. Relief of cardiorespiratory symptoms and increased physical activity after surgically induced weight loss: results from the Swedish Obese Subjects study. Arch Intern Med. 2000 Jun 26;160(12):1797-802. doi: 10.1001/archinte.160.12.1797.
PubMed 10871973Babb TG, Wyrick BL, Chase PJ, DeLorey DS, Rodder SG, Feng MY, Ranasinghe KG. Weight loss via diet and exercise improves exercise breathing mechanics in obese men. Chest. 2011 Aug;140(2):454-460. doi: 10.1378/chest.10-1088. Epub 2011 Jan 27.
PubMed 21273293Held M, Mittnacht M, Kolb M, Karl S, Jany B. Pulmonary and cardiac function in asymptomatic obese subjects and changes following a structured weight reduction program: a prospective observational study. PLoS One. 2014 Sep 18;9(9):e107480. doi: 10.1371/journal.pone.0107480. eCollection 2014.
PubMed 25233078Bhammar DM, Stickford JL, Bernhardt V, Babb TG. Effect of weight loss on operational lung volumes and oxygen cost of breathing in obese women. Int J Obes (Lond). 2016 Jun;40(6):998-1004. doi: 10.1038/ijo.2016.21. Epub 2016 Feb 12.
PubMed 26869243
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOWER-PULM (PULMonary Outcomes in Older Adults Empowered With Movement to Prevent Obesity and Weight Regain)
- ClinicalTrials.gov ID
- NCT03621098
- Acronym / sponsor ID
- EMPOWER-PULM / IRB00041663
- Conditions
- Obesity, Pulmonary Disease, Dyspnea
- Keywords
- Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Current participants in the parent study, EMPOWER (Empowered with Movement to Prevent Obesity and Weight Regain)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Participant retention
Time frame: Month 6 (end of study)
Measured by the number of participants who return for the 6 month testing
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.
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.
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
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).
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Background: PubMed 9106566Lazarus R, Sparrow D, Weiss ST. Effects of obesity and fat distribution on ventilatory function: the normative aging study. Chest. 1997 Apr;111(4):891-8. doi: 10.1378/chest.111.4.891.
- Background: PubMed 16963682Jones RL, Nzekwu MM. The effects of body mass index on lung volumes. Chest. 2006 Sep;130(3):827-33. doi: 10.1378/chest.130.3.827.
- Background: PubMed 18420968Babb TG, Ranasinghe KG, Comeau LA, Semon TL, Schwartz B. Dyspnea on exertion in obese women: association with an increased oxygen cost of breathing. Am J Respir Crit Care Med. 2008 Jul 15;178(2):116-23. doi: 10.1164/rccm.200706-875OC. Epub 2008 Apr 17.
- Background: PubMed 17955030Salome CM, Munoz PA, Berend N, Thorpe CW, Schachter LM, King GG. Effect of obesity on breathlessness and airway responsiveness to methacholine in non-asthmatic subjects. Int J Obes (Lond). 2008 Mar;32(3):502-9. doi: 10.1038/sj.ijo.0803752. Epub 2007 Oct 23.
- Background: PubMed 18046878Sharma G, Goodwin J. Effect of aging on respiratory system physiology and immunology. Clin Interv Aging. 2006;1(3):253-60. doi: 10.2147/ciia.2006.1.3.253.
- Background: PubMed 18645577Rossi A, Fantin F, Di Francesco V, Guariento S, Giuliano K, Fontana G, Micciolo R, Solerte SB, Bosello O, Zamboni M. Body composition and pulmonary function in the elderly: a 7-year longitudinal study. Int J Obes (Lond). 2008 Sep;32(9):1423-30. doi: 10.1038/ijo.2008.103. Epub 2008 Jul 22.
- Background: PubMed 21498841Rossi AP, Watson NL, Newman AB, Harris TB, Kritchevsky SB, Bauer DC, Satterfield S, Goodpaster BH, Zamboni M. Effects of body composition and adipose tissue distribution on respiratory function in elderly men and women: the health, aging, and body composition study. J Gerontol A Biol Sci Med Sci. 2011 Jul;66(7):801-8. doi: 10.1093/gerona/glr059. Epub 2011 Apr 15.
- Background: PubMed 17986695Alley DE, Chang VW. The changing relationship of obesity and disability, 1988-2004. JAMA. 2007 Nov 7;298(17):2020-7. doi: 10.1001/jama.298.17.2020.
- Background: PubMed 24913317Vasquez E, Batsis JA, Germain CM, Shaw BA. Impact of obesity and physical activity on functional outcomes in the elderly: data from NHANES 2005-2010. J Aging Health. 2014 Sep;26(6):1032-46. doi: 10.1177/0898264314535635. Epub 2014 Jun 9.
- Background: PubMed 24961825American College of Cardiology/American Heart Association Task Force on Practice Guidelines, Obesity Expert Panel, 2013. Executive summary: Guidelines (2013) for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society published by the Obesity Society and American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Based on a systematic review from the The Obesity Expert Panel, 2013. Obesity (Silver Spring). 2014 Jul;22 Suppl 2:S5-39. doi: 10.1002/oby.20821. No abstract available.
- Background: PubMed 21689991Wei YF, Tseng WK, Huang CK, Tai CM, Hsuan CF, Wu HD. Surgically induced weight loss, including reduction in waist circumference, is associated with improved pulmonary function in obese patients. Surg Obes Relat Dis. 2011 Sep-Oct;7(5):599-604. doi: 10.1016/j.soard.2011.04.221. Epub 2011 Apr 19.
- Background: PubMed 10871973Karason K, Lindroos AK, Stenlof K, Sjostrom L. Relief of cardiorespiratory symptoms and increased physical activity after surgically induced weight loss: results from the Swedish Obese Subjects study. Arch Intern Med. 2000 Jun 26;160(12):1797-802. doi: 10.1001/archinte.160.12.1797.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J Nicklas, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Pulmonary Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who are able to undergo Pulmonary Function (time frame: Month 6 (end of study)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621098, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.