Status:
COMPLETED
The Vitality, Independence, and Vigor in Elders Study I Clinical Trial
Lead Sponsor:
Tufts University
Conditions:
Functionally Limited
Sedentary
Eligibility:
All Genders
65+ years
Phase:
NA
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....
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 signifi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01198886
Start Date
September 1 2010
End Date
May 1 2014
Last Update
May 13 2015
Active Locations (17)
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1
Drake Village
Arlington, Massachusetts, United States, 02474
2
Nashoba Park
Ayer, Massachusetts, United States, 01432
3
Compass on the Bay
Boston, Massachusetts, United States, 02127
4
Chestnut Park at Cleveland Circle
Brighton, Massachusetts, United States, 02135