MedTrace Logo

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

NCT01198886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2015-05-13

No results posted yet for this study

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

Interventions

OTHER

Successful Aging Program

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

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.

Sponsors & Collaborators

  • Tufts University

    lead OTHER

Principal Investigators

  • Miriam E Nelson, PhD · Tufts University

  • Sara C. Folta, PhD · Tufts University

  • Roger F. Fielding, PhD · Tufts University

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-01-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01198886 on ClinicalTrials.gov