The Vitality, Independence, and Vigor in Elders Study I Clinical Trial (VIVE I)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Functional Mobility, Vitamin D Status, Bio-markers of Muscle Health, and Psychosocial Factors Such as Well-being. |
Other: Successful Aging Program Other: Exercise-Nutrition Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, 3 months, 6 months, and 12 months into the study ] [ Designated as safety issue: No ]Tests of functional mobility that include strength and balance. Appropriate for older adults.
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
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.
Contacts and Locations| Contact: Michael P Corcoran, PhD | 617-636-3414 | michael.corcoran@tufts.edu |
| United States, Massachusetts | |
| Drake Village | Recruiting |
| Arlington, Massachusetts, United States, 02474 | |
| Contact: John Griffin 781-646-3400 | |
| Nashoba Park | Terminated |
| Ayer, Massachusetts, United States, 01432 | |
| Compass on the Bay | Terminated |
| Boston, Massachusetts, United States, 02127 | |
| Chestnut Park at Cleveland Circle | Suspended |
| Brighton, Massachusetts, United States, 02135 | |
| Neville Place at Fresh Pond | Active, not recruiting |
| Cambridge, Massachusetts, United States, 02138 | |
| Youville House | Recruiting |
| Cambridge, Massachusetts, United States, 02138 | |
| Contact: Joanne Parsons 617-491-1234 | |
| The Cambridge Homes | Withdrawn |
| Cambridge, Massachusetts, United States, 02138 | |
| Chelmsford Crossings | Recruiting |
| Chelmsford, Massachusetts, United States, 01824 | |
| Contact: Jim Kingsbury 978-250-8855 | |
| Putnam Farms at Danvers | Terminated |
| Danvers, Massachusetts, United States, 01923 | |
| Standish Village at Lower Mills | Terminated |
| Dorchester, Massachusetts, United States, 02124 | |
| Youville Place | Recruiting |
| Lexington, Massachusetts, United States, 02421 | |
| Contact: Joanne Scianna 781-862-4289 | |
| Methuen Village | Recruiting |
| Methuen, Massachusetts, United States, 01844 | |
| Contact: Kathleen Corey-Rahme 978-685-2220 | |
| Coleman House | Recruiting |
| Newton, Massachusetts, United States, 02459 | |
| Contact: Francine Godfrey 617-921-2343 | |
| The Falls at Cordingly Dam | Terminated |
| Newton, Massachusetts, United States, 02462 | |
| Golda Meir House | Active, not recruiting |
| Newton, Massachusetts, United States, 02466 | |
| Evans Park at Newton Center | Suspended |
| Newton, Massachusetts, United States, 02458 | |
| Holland Street Center | Suspended |
| Somerville, Massachusetts, United States, 02144 | |
| Waltham Crossings | Terminated |
| Waltham, Massachusetts, United States, 02151 | |
| Study Director: | Miriam E Nelson, PhD | Tufts University |
More Information
No publications provided
| Responsible Party: | Sara C. Folta - Principal Investigator, Tufts University |
| ClinicalTrials.gov Identifier: | NCT01198886 History of Changes |
| Other Study ID Numbers: | 1006010, 09.37.CLI |
| Study First Received: | September 8, 2010 |
| Last Updated: | July 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 16, 2013