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The primary objective of this study is to evaluate changes in functional status that result
from an Exercise-Nutrition Program (ENP) targeted toward older adults residing at senior
- The primary hypothesis is that over the 6-month intervention period subjects in the
intervention group will realize significant improvements in lower extremity function
compared to a control group.
To evaluate changes in nutritional status that result from the ENP.
- The secondary hypothesis is that subjects in the intervention group will realize
significant increases in circulating IGF-1 and 25-hydroxy vitamin D (25(OH)D) and
demonstrate improvements in nutritional status compared to a control group.
To evaluate changes in inflammatory status that result from the ENP.
- Subjects in the ENP group will exhibit reduced concentrations of circulating interleukin-6
(IL-6) compared with the control group.
To evaluate changes in psychosocial factors that result from the ENP
- The related hypothesis is that over the 6-month intervention period subjects in the
intervention group will increase exercise self-efficacy, intrinsic motivation to
exercise, and satisfaction of psychological needs compared to a control group.
- Additionally it is hypothesized that subjects in the intervention group will realize
improvements in mood and quality of life compared to a control group.
To assess the feasibility of conducting the Exercise-Nutrition Program in a senior housing
Ages:65 and older
Inclusion Criteria: - Age 65+ - Living at a senior housing facility - SPPB score of 3-9 - BMI <35 - 6CIT < or equal 14 - Permission of primary care provider - Willingness to be randomized to either treatment group Exclusion Criteria: - Failure to provide informed consent - Participate in >125 minutes per week of moderate to vigorous physical activity - Moderate to severe cognitive impairment (6CIT >15) - Inability to communicate due to severe, uncorrectable hearing loss or speech disorder - Severe visual impairment (if it precludes completion of assessments and/or intervention) - Wheelchair bound - Late-stage, progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, ALS - Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease - Terminal illness with life expectancy less than 12 months, as determined by a physician - Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen - Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina - Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia), excessive alcohol use (>14 drinks per wk); persons with depression will not be excluded - Surgery in the previous 6 months - Patient who cannot be expected to comply with treatment - Inability to obtain signed authorization from participant's primary care health care provider.
Sponsor: Tufts University
Trial ID: NCT01198886
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