Lifestyle Intervention Trial in Obese Elderly

Biomedical Research Institute of New Mexico160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Obesity

Interventions

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

New Mexico VA Medical Center and University of New Mexico School of Medicine

Albuquerque, New Mexico, United States

Baylor College of Medicine

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 Months

Secondary Outcomes

Change in lean mass

Assessed using dual energy x-ray absorptiometry (DXA)

Time frame: 6 months

Change in fat mass

Assessed using DXA

Time frame: 6 months

Change in muscle strength

Assessed using 1-repetition maximum and dynamometry

Time frame: 6 months

Change in gait speed

Measured as time to walk a certain distance

Time frame: 6 months

Change in areal bone mineral density

Assessed by using DXA

Time frame: 6 months

Change in biochemical marker for bone turnover and bone metabolism

Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay

Time frame: 6 months

Change in circulating cytokines

Assessed by using enzyme linked immunoassay

Time frame: 6 months

Change in adipocytokines

Assessed by using enzyme linked immunoassay

Time frame: 6 months

Change in aerobic capacity

Assessed by using indirect calorimetry during graded exercise stress test

Time frame: 6 months

Change in systolic and diastolic blood pressure

Assessed by using sphygmomanometer

Time frame: 6 months

Change in serum glucose

Assessed by glucose oxidase method

Time frame: 6 months

Change in serum lipids

Assessed by automated enzymatic/colorimetric assays

Time frame: 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)

Time frame: 6 months

Change in habitual physical activity measured objectively

Using accelerometers

Time frame: 6 months

Change in serum insulin

Assessed by immunoassay

Time frame: 6 months

Change in serum estradiol

Assessed by immunoassay

Time frame: 6 months

Change in 25 hydroxyvitamin D

Assessed by immunoassay

Time frame: 6 months

Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score

Assessed by IWQO-liteL questionnaire

Time frame: 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)

Time frame: 6 months

Change in gene expression of muscle anabolic and catabolic factors

Assessed by reverse transcription polymerase chain reaction and nanostring

Time frame: 6 months

Change in protein expression of muscle anabolic and catabolic factors

Assessed by western blotting

Time frame: 6 months

Change in concentration of targeted metabolites

Assessed by liquid chromatography hyphenated with mass spectrometry techniques

Time frame: 6 months

Change in dynamic balance

Assessed by the obstacle course

Time frame: 6 months

Change in static balance

Assessed by one leg stance

Time frame: 6 months

Change in modified mini-mental exam

Assessed by using cognitive instrument testing

Time frame: 6 months

Change in word fluency

Assessed by using cognitive instrument testing

Time frame: 6 months

Change in trail a and trail b

Assessed by using cognitive instrument testing

Time frame: 6 months

Change in Ray Auditory verbal learning test

Assessed by using cognitive instrument testing

Time frame: 6 months

Change in muscle protein synthesis rate

Assessed by stable isotope methodology

Time frame: 6 months

Change in thigh muscle and fat mass

Assessed by magnetic resonance imaging (MRI)

Time frame: 6 months

Change in visceral fat mass

Assessed by MRI

Time frame: 6 months

Change in mood

Assessed by geriatric depression scale (score range: 0 to 30, where lower scores indicating better mood)

Time frame: 6 months

Change in waist circumference

Using a tape measure

Time frame: 6 months

Change in serum testosterone

Assessed by immunoassay

Time frame: 6 months

Change in subjective ability to function

Assessed by Functional Status Questionnaire (score range: 0 to 36 with higher scores indicating better function)

Time frame: 6 months

Change is serum sclerostin

Assessed by immunoassay

Time frame: 6 months

Change in parathyroid hormone

Assessed by immunoassay

Time frame: 6 months