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

NCT01198886 | Completed DMC

• 2 other identifiers: 100601009.37.CLI
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 17

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.

Conditions

Functionally Limited; Sedentary

Keywords

Mobility disability; Older adults; Physical activity; Nutritional status

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB)

  Tests of functional mobility that include strength and balance. Appropriate for older adults.

  Baseline, 3 months, 6 months, and 12 months into the study

Study Arms (2)

Successful Aging Program

PLACEBO COMPARATOR

Other: Successful Aging Program

Exercise-Nutrition Program

EXPERIMENTAL

Other: Exercise-Nutrition Program

Interventions

Successful Aging Program OTHER

Once per week discussion on lifestyle topics important to older adults. Classes conclude with a gentle upper body stretching routine.

Successful Aging Program

Exercise-Nutrition Program OTHER

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.

Exercise-Nutrition Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65+
• Living at a senior housing facility
• SPPB score of 3-9
• BMI \<35
• CIT \< or = 14
• Permission of primary care provider
• Willingness to be randomized to either treatment group

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (17)

Drake Village

Arlington, Massachusetts, 02474, United States

Location

Nashoba Park

Ayer, Massachusetts, 01432, United States

Location

Compass on the Bay

Boston, Massachusetts, 02127, United States

Location

Chestnut Park at Cleveland Circle

Brighton, Massachusetts, 02135, United States

Location

Neville Place at Fresh Pond

Cambridge, Massachusetts, 02138, United States

Location

Youville House

Cambridge, Massachusetts, 02138, United States

Location

Chelmsford Crossings

Chelmsford, Massachusetts, 01824, United States

Location

Putnam Farms at Danvers

Danvers, Massachusetts, 01923, United States

Location

Standish Village at Lower Mills

Dorchester, Massachusetts, 02124, United States

Location

Youville Place

Lexington, Massachusetts, 02421, United States

Location

Methuen Village

Methuen, Massachusetts, 01844, United States

Location

Evans Park at Newton Center

Newton, Massachusetts, 02458, United States

Location

Coleman House

Newton, Massachusetts, 02459, United States

Location

The Falls at Cordingly Dam

Newton, Massachusetts, 02462, United States

Location

Golda Meir House

Newton, Massachusetts, 02466, United States

Location

Holland Street Center

Somerville, Massachusetts, 02144, United States

Location

Waltham Crossings

Waltham, Massachusetts, 02151, United States

Location

Related Publications (1)

• Corcoran MP, Chui KK, White DK, Reid KF, Kirn D, Nelson ME, Sacheck JM, Folta SC, Fielding RA. Accelerometer Assessment of Physical Activity and Its Association with Physical Function in Older Adults Residing at Assisted Care Facilities. J Nutr Health Aging. 2016;20(7):752-8. doi: 10.1007/s12603-015-0640-7.

  PMID: 27499309 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Miriam E Nelson, PhD

  Tufts University

  STUDY DIRECTOR

• Sara C. Folta, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

• Roger F. Fielding, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

US (17)