Randomized Study of Exercise and Vitamin D in Frail Elderly Subjects.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Elderly, Frail
Intervention: Vitamin D + Sham Exercise (Drug); Vitamin D Placebo + Exercise (Procedure); Vitamin D Placebo + Sham Exercise (Procedure); Vitamin D + Exercise (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: 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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.
Secondary outcome: Evaluation of utility and variability of mobility function tests and biomarekrs, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.
Eligibility
Minimum age: 75 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Elderly subjects with moderate frailty residing in assisted living facilities.
Exclusion Criteria:
- Presence of progressive, unstable chronic disease; hyperparathyroidism,
hypercalcemia.
Locations and Contacts
Pfizer Investigational Site, Farmington, Connecticut 06030-5215, United States
Pfizer Investigational Site, Hyattsville, Maryland 20782, United States
Pfizer Investigational Site, Roslindale, Massachusetts 02131-1011, United States
Pfizer Investigational Site, New York, New York 10040-3403, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2005
Ending date: January 2008
Last updated: May 8, 2008
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