Lifestyle Intervention Trial in Obese Elderly
This trial is active, not recruiting.
|Treatments||diet + resistance training, diet + aerobic training, diet + resistance/aerobic exercise|
|Sponsor||Biomedical Research Institute of New Mexico|
|Collaborator||National Institute on Aging (NIA)|
|Start date||February 2010|
|End date||January 2016|
|Trial size||160 participants|
|Trial identifier||NCT01065636, R01-AG031176, R01AG031176|
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.
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Physical Function and Body Composition
time frame: 6 Months
Bone markers, hormones, muscle cytokines, muscle protein synthesis, cardiometabolic risk factors, cognition, mood, quality of life
time frame: 6 months
Male or female participants from 65 years up to 85 years old.
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 >1.5mg/dl - No commitments, life situations or conditions that would interfere with their participation in the study
|Official title||Exercise Interventions During Voluntary Weight Loss in Obese Older Adults|
|Principal investigator||Dennis T Villareal, MD FACP FACE|
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