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Comprehensive Intervention for Falls Prevention in the Elderly

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ClinicalTrials.gov Identifier: NCT00413933
Recruitment Status : Terminated (The study was stopped due to lack of funding)
First Posted : December 20, 2006
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Yan Press, Soroka University Medical Center

Brief Summary:
The purpose of this study is to determine whether the comprehensive multidisciplinary intervention (geriatrician, physical therapist and occupational therapist falls risk assessment and intervention)is effective in the falls prevention in the community dwelling elderly.

Condition or disease Intervention/treatment
Accidental Falls Procedure: Comprehensive Multidisciplinary Intervention

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : April 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intrevention group
each subject in intervention group will get 15 weekly sessions (each session - 45 minutes) of specified exercise from a physical therapist that specializes in fall prevention and walking device recommendations. All subjects will get brochure for home exercise. It will be expected for intervention group to exercise twice daily, each time for 20 minutes in addition to the PT sessions
Procedure: Comprehensive Multidisciplinary Intervention
Comprehensive Multidisciplinary Intervention
No Intervention: Control group

Those who agree to participate in the study will fill in questionnaire about falls (causes, circumstance, results). All will pass through: cognitive assessment by the Mini-Mental State Examination (MMSE), affective assessment by the 15-item Geriatric Depression Scale (GDS), functional assessment by Barthel Index (BI), visual assessment by Snellen charts and basic gait assessment by a "Timed get Up and Go" test (TU&G).

Participants that fulfill inclusion criteria will be randomly assigned to the intervention group or the control group

Primary Outcome Measures :
  1. number of falls [ Time Frame: 4 and 12 monthes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Living in Beer Sheva or Ofakim , Israel
  • Members of Clalit HMO
  • 1 or more falls in past 12 month (self-reported)
  • Age 65 or more
  • Mobile outdoors without wheelchair

Exclusion Criteria:

  • Seriously ill patients - as dyspnea with light exercise, unstable heart disease
  • MMSE less than 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413933

Department of Family Medicine, Faculty of Health Sciences, Ben Gurion University of the Negev
Beer- Sheva, Israel
Sponsors and Collaborators
Soroka University Medical Center
Principal Investigator: Yan Press, MD Ben-Gurion University of the Negev

Responsible Party: Yan Press, head of Unit for Community Geriatrics, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00413933     History of Changes
Other Study ID Numbers: sor444506ctil
First Posted: December 20, 2006    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: December 2006

Keywords provided by Yan Press, Soroka University Medical Center:
multidisciplinary intervention
health care utilization