The Vitality, Independence, and Vigor in Elders Study I Clinical Trial

Completed · Not applicable

Conditions studied: Functionally Limited, Sedentary

In brief

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 insulin-like growth factor-1 (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.

Key facts

Study ID

NCT01198886

Run by

Tufts University

People needed

121

Starts

2010-09-01

Expected to finish

2014-05-01

Last updated by the study team

2015-05-13

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 65+
• Living at a senior housing facility
• SPPB score of 3-9
• BMI <35
• 6CIT < or = 14
• Permission of primary care provider
• Willingness to be randomized to either treatment group

You may not qualify if…

• 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, acute lateral sclerosis.
• 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.

Where it is running

• Drake Village — Arlington, Massachusetts, United States
• Nashoba Park — Ayer, Massachusetts, United States
• Compass on the Bay — Boston, Massachusetts, United States
• Chestnut Park at Cleveland Circle — Brighton, Massachusetts, United States
• Neville Place at Fresh Pond — Cambridge, Massachusetts, United States
• Youville House — Cambridge, Massachusetts, United States
• Chelmsford Crossings — Chelmsford, Massachusetts, United States
• Putnam Farms at Danvers — Danvers, Massachusetts, United States
• Standish Village at Lower Mills — Dorchester, Massachusetts, United States
• Youville Place — Lexington, Massachusetts, United States
• Methuen Village — Methuen, Massachusetts, United States
• Evans Park at Newton Center — Newton, Massachusetts, United States
• Coleman House — Newton, Massachusetts, United States
• The Falls at Cordingly Dam — Newton, Massachusetts, United States
• Golda Meir House — Newton, Massachusetts, United States
• Holland Street Center — Somerville, Massachusetts, United States
• Waltham Crossings — Waltham, Massachusetts, United States

Full record on ClinicalTrials.gov

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