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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01198886
First received: September 8, 2010
Last updated: June 5, 2013
Last verified: June 2013
  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 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 Intervention
Functionally Limited
Sedentary
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

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • 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.


Enrollment: 121
Study Start Date: September 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: January 2013 (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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198886

Locations
United States, Massachusetts
Drake Village
Arlington, Massachusetts, United States, 02474
Nashoba Park
Ayer, Massachusetts, United States, 01432
Compass on the Bay
Boston, Massachusetts, United States, 02127
Chestnut Park at Cleveland Circle
Brighton, Massachusetts, United States, 02135
Neville Place at Fresh Pond
Cambridge, Massachusetts, United States, 02138
Youville House
Cambridge, Massachusetts, United States, 02138
Chelmsford Crossings
Chelmsford, Massachusetts, United States, 01824
Putnam Farms at Danvers
Danvers, Massachusetts, United States, 01923
Standish Village at Lower Mills
Dorchester, Massachusetts, United States, 02124
Youville Place
Lexington, Massachusetts, United States, 02421
Methuen Village
Methuen, Massachusetts, United States, 01844
The Falls at Cordingly Dam
Newton, Massachusetts, United States, 02462
Coleman House
Newton, Massachusetts, United States, 02459
Evans Park at Newton Center
Newton, Massachusetts, United States, 02458
Golda Meir House
Newton, Massachusetts, United States, 02466
Holland Street Center
Somerville, Massachusetts, United States, 02144
Waltham Crossings
Waltham, Massachusetts, United States, 02151
Sponsors and Collaborators
Tufts University
Investigators
Study Director: Miriam E Nelson, PhD Tufts University
Principal Investigator: Sara C. Folta, PhD Tufts University
Principal Investigator: Roger F. Fielding, PhD Tufts University
  More Information

No publications provided

Responsible Party: 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: June 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
Mobility disability
Older adults
Physical activity
Nutritional status

ClinicalTrials.gov processed this record on July 24, 2014