Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

January 7, 2009 updated by: Pfizer

Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects

The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030-5215
        • Pfizer Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Pfizer Investigational Site
    • Massachusetts
      • Roslindale, Massachusetts, United States, 02131-1011
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10040-3403
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elderly subjects with moderate frailty residing in assisted living facilities.

Exclusion Criteria:

  • Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Vitamin D + Exercise
1000 IU per day of Vitamin D + Exercise
Experimental: B
Drug: Vitamin D + Sham Exercise
1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise
Experimental: C
Procedure: Vitamin D Placebo + Exercise
Vitamin D placebo + Exercise
Placebo Comparator: D
Procedure: Vitamin D Placebo + Sham Exercise
Vitamin D placebo + Sham (equivalent to placebo) Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.
Time Frame: Throughout trial
Throughout trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of utility and variability of mobility function tests and biomarkers, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.
Time Frame: throughout trial
throughout trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2009

Last Update Submitted That Met QC Criteria

January 7, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9001116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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