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The Vitality, Independence, and Vigor in Elders Study I Clinical Trial (VIVE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01198886
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Tufts University

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.


Condition or disease Intervention/treatment Phase
Functionally Limited Sedentary Other: Successful Aging Program Other: Exercise-Nutrition Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
Show Show 17 study locations
Sponsors and Collaborators
Tufts University
Investigators
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Study Director: Miriam E Nelson, PhD Tufts University
Principal Investigator: Sara C. Folta, PhD Tufts University
Principal Investigator: Roger F. Fielding, PhD Tufts University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01198886    
Other Study ID Numbers: 1006010
09.37.CLI ( Other Grant/Funding Number: Nestle Nutrition )
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Tufts University:
Mobility disability
Older adults
Physical activity
Nutritional status