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Vitality, Independence, and Vigor in Elders Study (VIVE Study): Effects of an Exercise and Nutrition Program on Functionality in the Elderly

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Trial Conditions
  • Functional Mobility, Vitamin D Status, Bio-markers of Muscle Health, and Psychosocial Factors Such as Well-being.
What is the purpose of this trial?

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 housing facilities. - 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. Secondary objectives 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 facility setting.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
65 and older

Gender:
Both

Eligibility

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.

Gender: Both
Steward Physician(s)
  • Miriam E Nelson, PhD
Trial Interventions
Other
  • Successful Aging Program
  • Exercise-Nutrition Program
Physician Researcher

Investigator Name:

  • Miriam E Nelson, PhD

Other Information

Sponsor: Tufts University
Phase: N/A
Trial ID: NCT01198886
Volunteers:  Accepting Healthy Volunteers

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