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

Sedentary Clinical Trial

— VIVE-1  

Official title:

Vitality, Independence, and Vigor in Elders Study (VIVE Study): Effects of an Exercise and Nutrition Program on Functionality in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198886
• Other study ID #: 1006010
• Secondary ID: 09.37.CLI
• Status: Completed
• Phase: N/A
• First received: September 8, 2010
• Last updated: May 11, 2015
• Start date: September 2010
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Functionally Limited
• Sedentary

Intervention

Other:
• Successful Aging Program
Once per week discussion on lifestyle topics important to older adults. Classes conclude with a gentle upper body stretching routine.
• 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.

Locations

Country	Name	City	State
United States	Drake Village	Arlington	Massachusetts
United States	Nashoba Park	Ayer	Massachusetts
United States	Compass on the Bay	Boston	Massachusetts
United States	Chestnut Park at Cleveland Circle	Brighton	Massachusetts
United States	Neville Place at Fresh Pond	Cambridge	Massachusetts
United States	Youville House	Cambridge	Massachusetts
United States	Chelmsford Crossings	Chelmsford	Massachusetts
United States	Putnam Farms at Danvers	Danvers	Massachusetts
United States	Standish Village at Lower Mills	Dorchester	Massachusetts
United States	Youville Place	Lexington	Massachusetts
United States	Methuen Village	Methuen	Massachusetts
United States	Coleman House	Newton	Massachusetts
United States	Evans Park at Newton Center	Newton	Massachusetts
United States	Golda Meir House	Newton	Massachusetts
United States	The Falls at Cordingly Dam	Newton	Massachusetts
United States	Holland Street Center	Somerville	Massachusetts
United States	Waltham Crossings	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No