Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

Overview

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.

Full Title of Study: “Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Detailed Description

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

Interventions

  • Drug: Vitamin D + Sham Exercise
    • 1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise
  • Procedure: Vitamin D Placebo + Exercise
    • Vitamin D placebo + Exercise
  • Procedure: Vitamin D Placebo + Sham Exercise
    • Vitamin D placebo + Sham (equivalent to placebo) Exercise
  • Drug: Vitamin D + Exercise
    • 1000 IU per day of Vitamin D + Exercise

Arms, Groups and Cohorts

  • Experimental: C
  • Experimental: B
  • Experimental: A
  • Placebo Comparator: D

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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