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

Pfizer1 site in 1 country64 target enrollmentOctober 2005

InterventionsVitamin D Placebo + Exercise Vitamin D + Sham Exercise Vitamin D + Exercise Vitamin D Placebo + Sham Exercise

DrugsVitamin D + Sham Exercise Vitamin D + Exercise

Overview

Phase: Phase 1
Intervention: Vitamin D Placebo + Exercise
Conditions: Elderly, Frail
Sponsor: Pfizer
Enrollment: 64
Locations: 1
Primary Endpoint: Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.
Status: Terminated
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

January 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

C

Intervention: Vitamin D Placebo + Exercise

B

Intervention: Vitamin D + Sham Exercise

A

Intervention: Vitamin D + Exercise

D

Intervention: Vitamin D Placebo + Sham Exercise

Outcomes

Primary Outcomes

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 Outcomes

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.(throughout trial)