The Vitality, Independence, and Vigor in Elders Study I Clinical Trial (VIVE-1)
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|ClinicalTrials.gov Identifier: NCT01198886|
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : May 13, 2015
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Functionally Limited Sedentary||Other: Successful Aging Program Other: Exercise-Nutrition Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Vitality, Independence, and Vigor in Elders Study (VIVE Study): Effects of an Exercise and Nutrition Program on Functionality in the Elderly|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||May 2014|
|Placebo Comparator: Successful Aging Program||
Other: Successful Aging Program
Once per week discussion on lifestyle topics important to older adults. Classes conclude with a gentle upper body stretching routine.
|Experimental: Exercise-Nutrition Program||
Other: Exercise-Nutrition Program
Targeted exercise program offered 3-days per week at the study participants place of residence (senior housing facility). Other means to encourage physical activity outside of these exercise classes will be available. A nutrient-rich protein carbohydrate experimental beverage will be taken following the exercise sessions.
- Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, 3 months, 6 months, and 12 months into the study ]Tests of functional mobility that include strength and balance. Appropriate for older adults.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198886
|Study Director:||Miriam E Nelson, PhD||Tufts University|
|Principal Investigator:||Sara C. Folta, PhD||Tufts University|
|Principal Investigator:||Roger F. Fielding, PhD||Tufts University|