Lifestyle Intervention Trial in Obese Elderly (LITOE)

Exercise Interventions During Voluntary Weight Loss in Obese Older Adults

Obesity causes frailty in obese older adults by exacerbating the age-related decline in physical function. However, appropriate management of obesity in older adults is controversial. Weight loss without exercise could worsen frailty by accelerating the usual age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia, respectively. Because of the important problem of frailty in obese older adults, it is important to determine the most efficacious approach in reducing, or even reversing frailty in this population. The primary objective of this proposal is to evaluate which distinct type of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and reversing frailty in obese older adults.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Diet + Resistance Training; Behavioral: Diet + Aerobic Training; Behavioral: Diet + Resistance/Aerobic Exercise

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • New Mexico VA Medical Center and University of New Mexico School of Medicine
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 65-85 years old
• Obese men and women (BMI > or equal to 30 kg/m2)
• Stable weight (±2 kg) during the last 6 mos.
• Must be sedentary (regular exercise <1 h/wk or <2 x/wk for the last 6 mos.)
• Be judged, during the initial screening, to be well motivated and reliable

Exclusion Criteria:

• Any major chronic diseases
• Any condition or unstable diseases that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results that include but are not limited to:
• Cardiopulmonary disease (e.g., recent MI, unstable angina, stroke etc.)
• Severe orthopedic/musculoskeletal or neuromuscular impairments that would contraindicate participation in exercise
• Visual or hearing impairments that interfere with following directions
• Diagnosis of dementia
• History of malignancy during the past 5 yr
• Recent use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or biphosphonates during the last two years)
• Individuals on insulin or with a fasting blood glucose of > 140mg/dl, and/or a 2 hour post-glucose of >250 mg/dl
• BMD t-scores of <-2.3 of the lumbar spine and proximal femur
• serum creatinine >2.0 mg/dl
• No commitments, life situations or conditions that would interfere with their participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet + Resistance Exercise Training; Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week	Behavioral: Diet + Resistance Training; Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and resistance exercise training 3-days/week for 24 weeks.
Experimental: Diet + Aerobic Exercise Training; Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week	Behavioral: Diet + Aerobic Training; Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and aerobic exercise training 3-days/week for 24 weeks
Experimental: Diet + Combined Aerobic/Resistance Exercise; Weekly behavioral/diet-induced weight loss plus combined supervised resistance exercise training and aerobic exercise training three times a week	Behavioral: Diet + Resistance/Aerobic Exercise; Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and combined resistance/aerobic exercise training 3-days/week for 24 weeks
No Intervention: Control Group (No Diet/No Exercise); No diet No exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Function	The Physical Performance Test includes seven standardized tasks (walking 15.2 m [50 ft], putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg test) plus two additional tasks (going up and down four flights of stairs and making a 360-degree turn). The score for each task ranges from 0 to 4, with higher scores indicating better physical performance; a perfect score would be 36.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dynamic balance	Assessed by the obstacle course	6 months
Change in static balance	Assessed by one leg stance	6 months
Change in subjective ability to function	Assessed by Functional Status Questionnaire (score range: 0 to 36 with higher scores indicating better function)	6 months
Change in mood	Assessed by geriatric depression scale (score range: 0 to 30, where lower scores indicating better mood)	6 months
Change in Medical Outcomes 36-Item short form Health survey (SF-36)	Assessed by Physical component summary and mental component summary score (score range 0 to 100, with higher scores indicating better health status)	6 months
Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score	Assessed by IWQO-liteL questionnaire	6 months
Change in serum lipids	Assessed by automated enzymatic/colorimetric assays	6 months
Change in habitual physical activity assessed by questionnaires	Using the Stanford physical activity questionnaire (score range: 0 to 40 with higher scores indicating higher physical activity levels)	6 months
Change in habitual physical activity measured objectively	Using accelerometers	6 months
Change in lean mass	Assessed using dual energy x-ray absorptiometry (DXA)	6 months
Change in fat mass	Assessed using DXA	6 months
Change in muscle strength	Assessed using 1-repetition maximum and dynamometry	6 months
Change in gait speed	Measured as time to walk a certain distance	6 months
Change in areal bone mineral density	Assessed by using DXA	6 months
Change in biochemical marker for bone turnover and bone metabolism	Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay	6 months
Change in circulating cytokines	Assessed by using enzyme linked immunoassay	6 months
Change in adipocytokines	Assessed by using enzyme linked immunoassay	6 months
Change in aerobic capacity	Assessed by using indirect calorimetry during graded exercise stress test	6 months
Change in systolic and diastolic blood pressure	Assessed by using sphygmomanometer	6 months
Change in serum glucose	Assessed by glucose oxidase method	6 months
Change in serum insulin	Assessed by immunoassay	6 months
Change in serum estradiol	Assessed by immunoassay	6 months
Change in 25 hydroxyvitamin D	Assessed by immunoassay	6 months
Change in gene expression of muscle anabolic and catabolic factors	Assessed by reverse transcription polymerase chain reaction and nanostring	6 months
Change in protein expression of muscle anabolic and catabolic factors	Assessed by western blotting	6 months
Change in concentration of targeted metabolites	Assessed by liquid chromatography hyphenated with mass spectrometry techniques	6 months
Change in modified mini-mental exam	Assessed by using cognitive instrument testing	6 months
Change in word fluency	Assessed by using cognitive instrument testing	6 months
Change in trail a and trail b	Assessed by using cognitive instrument testing	6 months
Change in Ray Auditory verbal learning test	Assessed by using cognitive instrument testing	6 months
Change in muscle protein synthesis rate	Assessed by stable isotope methodology	6 months
Change in thigh muscle and fat mass	Assessed by magnetic resonance imaging (MRI)	6 months
Change in visceral fat mass	Assessed by MRI	6 months
Change in waist circumference	Using a tape measure	6 months
Change in serum testosterone	Assessed by immunoassay	6 months
Change is serum sclerostin	Assessed by immunoassay	6 months
Change in parathyroid hormone	Assessed by immunoassay	6 months

Collaborators and Investigators

• Sponsor: Biomedical Research Institute of New Mexico
• Collaborators: Baylor College of Medicine; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Dennis T Villareal, MD FACP FACE, Baylor College of Medicine

Publications and helpful links

General Publications

• Armamento-Villareal R, Aguirre L, Waters DL, Napoli N, Qualls C, Villareal DT. Effect of Aerobic or Resistance Exercise, or Both, on Bone Mineral Density and Bone Metabolism in Obese Older Adults While Dieting: A Randomized Controlled Trial. J Bone Miner Res. 2020 Mar;35(3):430-439. doi: 10.1002/jbmr.3905. Epub 2019 Dec 4.
• Colleluori G, Aguirre L, Phadnis U, Fowler K, Armamento-Villareal R, Sun Z, Brunetti L, Hyoung Park J, Kaipparettu BA, Putluri N, Auetumrongsawat V, Yarasheski K, Qualls C, Villareal DT. Aerobic Plus Resistance Exercise in Obese Older Adults Improves Muscle Protein Synthesis and Preserves Myocellular Quality Despite Weight Loss. Cell Metab. 2019 Aug 6;30(2):261-273.e6. doi: 10.1016/j.cmet.2019.06.008. Epub 2019 Jul 3.
• Villareal DT, Aguirre L, Gurney AB, Waters DL, Sinacore DR, Colombo E, Armamento-Villareal R, Qualls C. Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults. N Engl J Med. 2017 May 18;376(20):1943-1955. doi: 10.1056/NEJMoa1616338.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 8, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (Estimate): February 9, 2010

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: R01AG031176 (U.S. NIH Grant/Contract)