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

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:

• 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 the control group.
• Subjects in the ENP will exhibit reductions in circulating plasma IL-6 concentrations, which are indicative of systemic inflammatory status.
• 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.

Another major objective is to assess the feasibility of conducting the Exercise-Nutrition Program in a senior housing center facility setting.

TRIAL DESIGN

Type of trial The study objectives will be achieved in the context of a controlled, randomized field trial. Randomization will be by site (senior housing center). Intervention group subjects will participate in the Exercise-Nutrition Program (ENP). Control group subjects will participate in the Successful Aging Program (SAP), which will provide them with useful skills and an adequate attention control, but will not affect the primary outcome of this study.

Subjects, groups and centers:

In each study group the number of subjects to complete the study protocol will be 40 (see also 9.3 statistical section). Assuming a conservative dropout rate of 10% after the 3 month intervention and 15% at the end of the 6 month study, a sample of 53 subjects per group, or 106 total, will be required to be enrolled in the study. 16-20- senior housing centers will be recruited and each will run one class with an average size of at least 5 subjects (maximum 25 subjects).

Sites will be assigned to one of 2 groups:

Group 1: Exercise-Nutrition Program (ENP) Group 2: Successful Aging Program (SAP)

Duration of subject participation:

Subjects will undergo the proposed intervention for 6 months. The target population for this study will be elderly people (65 yrs+) living in senior housing centers.

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, 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.