Functionally Limited clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT01198886 Completed - Sedentary Clinical Trials

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

VIVE-1

Start date: September 2010
Phase: N/A
Study type: Interventional

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.