Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
The Vitality, Independence, and Vigor in Elders Study I Clinical Trial
NCT01198886 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01198886
The ClinicalTrials.gov registry entry for NCT01198886 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts University, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01198886 reports 17 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01198886?
The interventions under investigation include: Successful Aging Program (OTHER), Exercise-Nutrition Program (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01198886?
This trial is sponsored by Tufts University, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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