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

Sedentary Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

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

• NCT number: NCT01198886
• Study type: Interventional
• Source: Tufts University
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Completion date: May 2014