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NCT01198886 · ClinicalTrials.gov registry record · NA
The Vitality, Independence, and Vigor in Elders Study I Clinical Trial
A NA study of Sedentary and Functionally Limited, sponsored by Tufts University.
- Completed
- Registry status
- NA
- Development phase
- 121
- Enrollment target
- 17
- Study locations
NCT01198886: Completed NA study of Sedentary and Functionally Limited, sponsored by Tufts University.
NCT01198886 is a NA study of Sedentary and Functionally Limited that has completed, run by Tufts University. The registered enrollment target is 121 participants, below the 280-participant average among 7 other Sedentary trials with a reported enrollment target (57% lower). The trial reports 17 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01198886, a NA study of Sedentary and Functionally Limited, has completed, sponsored by Tufts University.
- COMPLETED
- Registry status
- NA
- Development phase
- 121 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
Tests of functional mobility that include strength and balance. Appropriate for older adults.
Conditions Studied
Interventions
- OTHER Successful Aging Program
- OTHER Exercise-Nutrition Program
Study Locations (17)
Massachusetts
- Drake Village - Arlington
- Nashoba Park - Ayer
- Compass on the Bay - Boston
- Chestnut Park at Cleveland Circle - Brighton
- Neville Place at Fresh Pond - Cambridge
- Youville House - Cambridge
- Chelmsford Crossings - Chelmsford
- Putnam Farms at Danvers - Danvers
- Standish Village at Lower Mills - Dorchester
- Youville Place - Lexington
- Methuen Village - Methuen
- Evans Park at Newton Center - Newton
- Coleman House - Newton
- The Falls at Cordingly Dam - Newton
- Golda Meir House - Newton
- Holland Street Center - Somerville
- Waltham Crossings - Waltham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-05 |
| Phase | NA |
What the finished NCT01198886 record still lists
NCT01198886 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 280-participant average among 7 other Sedentary trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Sedentary appearing as the primary indexed condition, and to 2 interventions - of which Successful Aging Program is the first listed.
NCT01198886 lists 17 locations in 1 state (Massachusetts).
Frequently Asked Questions
What is clinical trial NCT01198886 about?
NCT01198886 is a clinical study titled "The Vitality, Independence, and Vigor in Elders Study I Clinical Trial". 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 interventio...
What is the current status of trial NCT01198886?
This trial is currently completed. It is a NA study. The enrollment target is 121 participants. The study started on 2010-09. Estimated completion is 2014-05.
What conditions does trial NCT01198886 study?
This clinical trial studies the following conditions: Sedentary, Functionally Limited.
What interventions are being tested in trial NCT01198886?
The interventions under investigation include: Successful Aging Program (OTHER), Exercise-Nutrition Program (OTHER).
Who is sponsoring clinical trial NCT01198886?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01198886 being conducted?
This trial has 17 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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