Lifestyle Intervention Trial in Obese Elderly
- Conditions
- Obesity
- Interventions
- Behavioral: Diet + Aerobic TrainingBehavioral: Diet + Resistance TrainingBehavioral: Diet + Resistance/Aerobic Exercise
- Registration Number
- NCT01065636
- Lead Sponsor
- Biomedical Research Institute of New Mexico
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diet + Aerobic Exercise Training Diet + Aerobic Training Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week Diet + Resistance Exercise Training Diet + Resistance Training Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week Diet + Combined Aerobic/Resistance Exercise Diet + Resistance/Aerobic Exercise Weekly behavioral/diet-induced weight loss plus combined supervised resistance exercise training and aerobic exercise training three times a week
- Primary Outcome Measures
Name Time Method Change in Physical Function 6 Months 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.
- Secondary Outcome Measures
Name Time Method Change is serum sclerostin 6 months Assessed by immunoassay
Change in circulating cytokines 6 months Assessed by using enzyme linked immunoassay
Change in adipocytokines 6 months Assessed by using enzyme linked immunoassay
Change in parathyroid hormone 6 months Assessed by immunoassay
Change in modified mini-mental exam 6 months Assessed by using cognitive instrument testing
Change in waist circumference 6 months Using a tape measure
Change in 25 hydroxyvitamin D 6 months Assessed by immunoassay
Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score 6 months Assessed by IWQO-liteL questionnaire
Change in dynamic balance 6 months Assessed by the obstacle course
Change in word fluency 6 months Assessed by using cognitive instrument testing
Change in trail a and trail b 6 months Assessed by using cognitive instrument testing
Change in fat mass 6 months Assessed using DXA
Change in muscle strength 6 months Assessed using 1-repetition maximum and dynamometry
Change in areal bone mineral density 6 months Assessed by using DXA
Change in aerobic capacity 6 months Assessed by using indirect calorimetry during graded exercise stress test
Change in serum insulin 6 months Assessed by immunoassay
Change in Medical Outcomes 36-Item short form Health survey (SF-36) 6 months Assessed by Physical component summary and mental component summary score (score range 0 to 100, with higher scores indicating better health status)
Change in gene expression of muscle anabolic and catabolic factors 6 months Assessed by reverse transcription polymerase chain reaction and nanostring
Change in visceral fat mass 6 months Assessed by MRI
Change in gait speed 6 months Measured as time to walk a certain distance
Change in biochemical marker for bone turnover and bone metabolism 6 months Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay
Change in serum glucose 6 months Assessed by glucose oxidase method
Change in serum lipids 6 months Assessed by automated enzymatic/colorimetric assays
Change in serum estradiol 6 months Assessed by immunoassay
Change in lean mass 6 months Assessed using dual energy x-ray absorptiometry (DXA)
Change in systolic and diastolic blood pressure 6 months Assessed by using sphygmomanometer
Change in protein expression of muscle anabolic and catabolic factors 6 months Assessed by western blotting
Change in habitual physical activity assessed by questionnaires 6 months Using the Stanford physical activity questionnaire (score range: 0 to 40 with higher scores indicating higher physical activity levels)
Change in habitual physical activity measured objectively 6 months Using accelerometers
Change in concentration of targeted metabolites 6 months Assessed by liquid chromatography hyphenated with mass spectrometry techniques
Change in static balance 6 months Assessed by one leg stance
Change in Ray Auditory verbal learning test 6 months Assessed by using cognitive instrument testing
Change in muscle protein synthesis rate 6 months Assessed by stable isotope methodology
Change in serum testosterone 6 months Assessed by immunoassay
Change in thigh muscle and fat mass 6 months Assessed by magnetic resonance imaging (MRI)
Change in mood 6 months Assessed by geriatric depression scale (score range: 0 to 30, where lower scores indicating better mood)
Change in subjective ability to function 6 months Assessed by Functional Status Questionnaire (score range: 0 to 36 with higher scores indicating better function)
Trial Locations
- 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