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.
- Elderly subjects with moderate frailty residing in assisted living facilities.
- Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects | |||
| Official Title ICMJE | Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects | |||
| 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Elderly, Frail | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 64 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | January 2008 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 75 Years and older (Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00249704 | |||
| Other Study ID Numbers ICMJE | A9001116 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | January 2009 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
