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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.
- 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
- 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
- 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
- Elderly subjects with moderate frailty residing in assisted living facilities.
- Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
Gender Eligibility: All
Minimum Age: 75 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- 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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