Elderly, Frail
Conditions
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.
Interventions
DRUGVitamin D + Sham Exercise
1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise
PROCEDUREVitamin D Placebo + Exercise
Vitamin D placebo + Exercise
PROCEDUREVitamin D Placebo + Sham Exercise
Vitamin D placebo + Sham (equivalent to placebo) Exercise
DRUGVitamin D + Exercise
1000 IU per day of Vitamin D + Exercise
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elderly subjects with moderate frailty residing in assisted living facilities.
Exclusion criteria
* Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects. | Throughout trial |
Secondary
| 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. | throughout trial |
Countries
United States
Outcome results
None listed