Clinical trial NCT03621098: EMPOWER-PULM (PULMonary Outcomes in Older Adults Empowered With Movement to Prevent Obesity and Weight Regain)
Official title: EMPOWER-PULM (PULMonary Outcomes in Older Adults Empowered With Movement to Prevent Obesity and Weight Regain)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Pulmonary Disease
Dyspnea
Keywords: Exercise
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 76
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current participants in the parent study, EMPOWER (Empowered with Movement to Prevent Obesity and Weight Regain)

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)

Eligibility 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

Primary outcomes:
measure: Number of patients who are able to undergo Pulmonary Function
timeFrame: Month 6 (end of study)
measure: Number of patients who are able to undergo respiratory muscle strength testing
timeFrame: Month 6 (end of study)
measure: Participant retention
timeFrame: Month 6 (end of study)
measure: Assess FEV1 on pulmonary function testing for breathlessness
timeFrame: Month 6 (end of study)
measure: Assess FVC on pulmonary function testing for breathlessness
timeFrame: Month 6 (end of study)
measure: Lung volumes
timeFrame: Month 6 (end of study)
measure: Diffusing capacity
timeFrame: Month 6 (end of study)
measure: Respiratory muscle strength
timeFrame: Month 6 (end of study)
measure: Six minute walk distance
timeFrame: Month 6 (end of study)
measure: Dyspnea scores based on mMRC (Modified Medical Research Council)
timeFrame: Month 6 (end of study)
measure: Dyspnea scores based on USCD SOBQ (University of California Shortness of Breath Questionnaire)
timeFrame: Month 6 (end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Barbara J Nicklas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jones 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.
citation: Babb 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.
citation: Salome 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.
citation: Sharma 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.
citation: Rossi 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.
citation: Rossi 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.
citation: Alley 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.
citation: Vasquez 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.
citation: American 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.
citation: Wei 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.
citation: Karason 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.
citation: Babb 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.
citation: Held 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.
citation: Bhammar 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.
citation: Womack CJ, Harris DL, Katzel LI, Hagberg JM, Bleecker ER, Goldberg AP. Weight loss, not aerobic exercise, improves pulmonary function in older obese men. J Gerontol A Biol Sci Med Sci. 2000 Aug;55(8):M453-7. doi: 10.1093/gerona/55.8.m453.
citation: Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
citation: Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
citation: Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
citation: Macintyre N, Crapo RO, Viegi G, Johnson DC, van der Grinten CP, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, Gustafsson P, Hankinson J, Jensen R, McKay R, Miller MR, Navajas D, Pedersen OF, Pellegrino R, Wanger J. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005 Oct;26(4):720-35. doi: 10.1183/09031936.05.00034905. No abstract available.
citation: Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
citation: Tashkin DP, Altose MD, Connett JE, Kanner RE, Lee WW, Wise RA. Methacholine reactivity predicts changes in lung function over time in smokers with early chronic obstructive pulmonary disease. The Lung Health Study Research Group. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1802-11. doi: 10.1164/ajrccm.153.6.8665038.
citation: Colak Y, Afzal S, Lange P, Nordestgaard BG. Obese individuals experience wheezing without asthma but not asthma without wheezing: a Mendelian randomisation study of 85,437 adults from the Copenhagen General Population Study. Thorax. 2016 Mar;71(3):247-54. doi: 10.1136/thoraxjnl-2015-207379. Epub 2015 Oct 26.
citation: Fenger RV, Gonzalez-Quintela A, Vidal C, Husemoen LL, Skaaby T, Thuesen BH, Aadahl M, Madsen F, Linneberg A. The longitudinal relationship of changes of adiposity to changes in pulmonary function and risk of asthma in a general adult population. BMC Pulm Med. 2014 Dec 22;14:208. doi: 10.1186/1471-2466-14-208.
citation: American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
citation: Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30.
citation: Eakin EG, Resnikoff PM, Prewitt LM, Ries AL, Kaplan RM. Validation of a new dyspnea measure: the UCSD Shortness of Breath Questionnaire. University of California, San Diego. Chest. 1998 Mar;113(3):619-24. doi: 10.1378/chest.113.3.619.
citation: Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
citation: Chai-Coetzer CL, Antic NA, Rowland LS, Catcheside PG, Esterman A, Reed RL, Williams H, Dunn S, McEvoy RD. A simplified model of screening questionnaire and home monitoring for obstructive sleep apnoea in primary care. Thorax. 2011 Mar;66(3):213-9. doi: 10.1136/thx.2010.152801. Epub 2011 Jan 20.
citation: Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.
citation: Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, Kosinski M, Pendergraft TB, Jhingran P. Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006 Mar;117(3):549-56. doi: 10.1016/j.jaci.2006.01.011.
citation: Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax. 1992 Feb;47(2):76-83. doi: 10.1136/thx.47.2.76.
citation: Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific Quality of Life Questionnaire. J Clin Epidemiol. 1994 Jan;47(1):81-7. doi: 10.1016/0895-4356(94)90036-1.
citation: Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
citation: Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2006 Apr;100(4):616-21. doi: 10.1016/j.rmed.2005.08.012. Epub 2005 Oct 13.
citation: Cooper BG. An update on contraindications for lung function testing. Thorax. 2011 Aug;66(8):714-23. doi: 10.1136/thx.2010.139881. Epub 2010 Jul 29.