Vitality, Independence, and Vigor in Elders Study (VIVE Study): Effects of an Exercise and Nutrition Program on Functionality in the Elderly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 121
- Locations
- 17
- Primary Endpoint
- Short Physical Performance Battery (SPPB)
Study Overview
Brief Summary
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.
Detailed Description
Older adults are the fastest growing segment of the population in many countries around the world, and the maintenance of independence has emerged as a major public health priority. Although a significant decline in physical function was once considered an inevitable consequence of aging, many studies have demonstrated that targeted exercise programs can dramatically improve physical function, even into advanced age. There is also evidence that appropriately timed protein intake is important for exercise recovery and the growth and maintenance of lean body mass. Other nutrients may be important to muscle strength and function as well. Yet many older adults have poor nutritional status. A combined exercise and nutrition program for functionally at-risk older adults, conveniently offered in the senior housing facilities where many reside, has great potential to improve functional status and quality of life in this population.
Main objective
- The primary objective of this study is to evaluate changes in functional status that result from the Exercise-Nutrition Program (ENP).
- 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
The secondary objectives of the research project are:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Living at a senior housing facility
- •SPPB score of 3-9
- •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, 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.
Arms & Interventions
Successful Aging Program
Intervention: Successful Aging Program (Other)
Exercise-Nutrition Program
Intervention: Exercise-Nutrition Program (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported