Clinical trial NCT01065636: Lifestyle Intervention Trial in Obese Elderly
Official title: Exercise Interventions During Voluntary Weight Loss in Obese Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Biomedical Research Institute of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Baylor College of Medicine
First posted: 2010-02-09
Enrollment: 160
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Function
timeFrame: 6 Months
Secondary outcomes:
measure: Change in lean mass
timeFrame: 6 months
measure: Change in fat mass
timeFrame: 6 months
measure: Change in muscle strength
timeFrame: 6 months
measure: Change in gait speed
timeFrame: 6 months
measure: Change in areal bone mineral density
timeFrame: 6 months
measure: Change in biochemical marker for bone turnover and bone metabolism
timeFrame: 6 months
measure: Change in circulating cytokines
timeFrame: 6 months
measure: Change in adipocytokines
timeFrame: 6 months
measure: Change in aerobic capacity
timeFrame: 6 months
measure: Change in systolic and diastolic blood pressure
timeFrame: 6 months
measure: Change in serum glucose
timeFrame: 6 months
measure: Change in serum lipids
timeFrame: 6 months
measure: Change in habitual physical activity assessed by questionnaires
timeFrame: 6 months
measure: Change in habitual physical activity measured objectively
timeFrame: 6 months
measure: Change in serum insulin
timeFrame: 6 months
measure: Change in serum estradiol
timeFrame: 6 months
measure: Change in 25 hydroxyvitamin D
timeFrame: 6 months
measure: Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score
timeFrame: 6 months
measure: Change in Medical Outcomes 36-Item short form Health survey (SF-36)
timeFrame: 6 months
measure: Change in gene expression of muscle anabolic and catabolic factors
timeFrame: 6 months
measure: Change in protein expression of muscle anabolic and catabolic factors
timeFrame: 6 months
measure: Change in concentration of targeted metabolites
timeFrame: 6 months
measure: Change in dynamic balance
timeFrame: 6 months
measure: Change in static balance
timeFrame: 6 months
measure: Change in modified mini-mental exam
timeFrame: 6 months
measure: Change in word fluency
timeFrame: 6 months
measure: Change in trail a and trail b
timeFrame: 6 months
measure: Change in Ray Auditory verbal learning test
timeFrame: 6 months
measure: Change in muscle protein synthesis rate
timeFrame: 6 months
measure: Change in thigh muscle and fat mass
timeFrame: 6 months
measure: Change in visceral fat mass
timeFrame: 6 months
measure: Change in mood
timeFrame: 6 months
measure: Change in waist circumference
timeFrame: 6 months
measure: Change in serum testosterone
timeFrame: 6 months
measure: Change in subjective ability to function
timeFrame: 6 months
measure: Change is serum sclerostin
timeFrame: 6 months
measure: Change in parathyroid hormone
timeFrame: 6 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: New Mexico VA Medical Center and University of New Mexico School of Medicine
state: New Mexico
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Dennis T Villareal, MD FACP FACE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.