Clinical trial NCT00146107: Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men
Official title: Weight Loss and Exercise in Frail Obese Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: obesity
aging
exercise
diet
weight loss
physical function
Obesity in the Elderly
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 107
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of weight loss and exercise on physical function, body fat and muscle mass, bone strength, and quality of life.

Detailed description: Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty by exacerbating the decline in strength, endurance, balance and mobility associated with aging and physical inactivity. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on physical function, body composition, bone and muscle metabolism, and quality of life in frail, obese elderly men and women. The central hypothesis is that in frail obese elderly subjects, weight loss will improve physical function and quality of life, while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 110 elderly (65-85 years old) obese men and women (body mass index \[BMI\] \> 30 kg/m2) with physical frailty will be randomized to 4 treatment groups: 1) control, 2) 10% weight loss, 3) exercise training, and 4) 10% weight loss plus exercise training.

Eligibility criteria: Inclusion Criteria:

* Obese (BMI 30 or greater)
* Elderly (age 65 years or older)
* Frailty

Exclusion Criteria:

* Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results.
* Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years, or current use of bone acting drugs.

Primary outcomes:
measure: physical function
timeFrame: one year
Secondary outcomes:
measure: body composition
timeFrame: one year
measure: muscle protein synthesis
timeFrame: one year
measure: quality of life
timeFrame: one year
measure: cognition and mood
timeFrame: one year
measure: metabolism
timeFrame: one year
measure: bone mineral density
timeFrame: 1 year
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dennis T Villareal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20. doi: 10.1038/oby.2004.111.
citation: Colleluori G, Chen R, Napoli N, Aguirre LE, Qualls C, Villareal DT, Armamento-Villareal R. Fat Mass Follows a U-Shaped Distribution Based on Estradiol Levels in Postmenopausal Women. Front Endocrinol (Lausanne). 2018 Jul 2;9:315. doi: 10.3389/fendo.2018.00315. eCollection 2018.
citation: Colleluori G, Napoli N, Phadnis U, Armamento-Villareal R, Villareal DT. Effect of Weight Loss, Exercise, or Both on Undercarboxylated Osteocalcin and Insulin Secretion in Frail, Obese Older Adults. Oxid Med Cell Longev. 2017;2017:4807046. doi: 10.1155/2017/4807046. Epub 2017 Aug 23.
citation: Napoli N, Shah K, Waters DL, Sinacore DR, Qualls C, Villareal DT. Effect of weight loss, exercise, or both on cognition and quality of life in obese older adults. Am J Clin Nutr. 2014 Jul;100(1):189-98. doi: 10.3945/ajcn.113.082883. Epub 2014 Apr 30.
citation: Shah K, Armamento-Villareal R, Parimi N, Chode S, Sinacore DR, Hilton TN, Napoli N, Qualls C, Villareal DT. Exercise training in obese older adults prevents increase in bone turnover and attenuates decrease in hip bone mineral density induced by weight loss despite decline in bone-active hormones. J Bone Miner Res. 2011 Dec;26(12):2851-9. doi: 10.1002/jbmr.475.
citation: Villareal DT, Chode S, Parimi N, Sinacore DR, Hilton T, Armamento-Villareal R, Napoli N, Qualls C, Shah K. Weight loss, exercise, or both and physical function in obese older adults. N Engl J Med. 2011 Mar 31;364(13):1218-29. doi: 10.1056/NEJMoa1008234.