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Fall Prevention Among Community Living Elderly

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ClinicalTrials.gov Identifier: NCT01705912
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : October 12, 2012
Sponsor:
Collaborators:
Örebro County Council
Örebro University, Sweden
Information provided by (Responsible Party):
Gunilla Fahlstrom, Örebro County Council

Brief Summary:

The purpose of this study is to assess effects of a home exercise program, supervised by assistant nurses with the aim of preventing falls.

Community living persons 65 years of age or older having a risk of falling were invited to participate. Participants were randomized to either training or control.

The training program was individually designed by a physiotherapist and the 5-month program performance was supervised in the partcipants home by eight home visits from an assistant nurse.

All participants received a visit from an occupational therapist who assessed the home and, if necessary, gave advice.


Condition or disease Intervention/treatment Phase
Accidental Falls/Prevention and Control Other: Complete intervention Other: Basic intervention Not Applicable

Detailed Description:

Falls among elderly are a major public health problem, but preventive interventions containing physical exercise and home improvement are available.

In this study the crucial question was to test whether unlicensed staff, assistant nurses, could be used for preventive work.

Estimation of study power gave that 170 participants in each group would be needed to detect a difference in days with falls, the main outcome measure.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Fall Prevention by Assistant Nurses Among Community Living Elderly With Risk of Falling - a Randomized Controlled Trial
Study Start Date : January 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: Training
Complete intervention i.e. basic intervention + individual training program.
Other: Complete intervention
The basic intervention, an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. The intervention consisted of an individually designed home exercise program aiming at improving balance, muscle strength and walking ability. The program, which was made by the physiotherapist, should be performed three times a week. A minimum of 30 minutes of walking per week was recommended, encouring further walking on an individual basis. An assistant nurse made eight home visits to supervise, help and encourage performance of activities.

Active Comparator: Control
Basic intervention.
Other: Basic intervention
The basic interventions was an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention.




Primary Outcome Measures :
  1. Number of days with fall [ Time Frame: 12 months ]
    Self reported calendar data


Secondary Outcome Measures :
  1. Exercise [ Time Frame: 12 months ]
    Self reported calendar data


Other Outcome Measures:
  1. Strength [ Time Frame: Pre and post intervention, 5 months ]
    Chair stand test

  2. Balance [ Time Frame: Pre and post intervention, 5 months ]
    Falls efficacy scale (FES)

  3. Balance [ Time Frame: Pre and post intervention, 5 months ]
    Bergs balance scale

  4. Walking 3 metres test [ Time Frame: Pre and post intervention, 5 months ]
  5. Health related quality of life [ Time Frame: Pre and post intervention, 5 months ]
    Self reported interview data, SF-36

  6. Activities of daily living [ Time Frame: Pre and post intervention, 5 months ]
    ADL

  7. Walking [ Time Frame: 12 months ]
    Minutes of walking per day, self reported calendar data.

  8. Hospital days [ Time Frame: 12 months ]
    Hospital register data

  9. Hospital visits [ Time Frame: 12 months ]
    Hospital register data

  10. Fractures or other harms [ Time Frame: 12 months ]
    Hospital register data

  11. Strength [ Time Frame: Pre and post assessment, 5 months ]
    Timed Up and Go, TUG



Information from the National Library of Medicine

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

Inclusion Criteria:

  • community living persons at least 65 years old
  • independent walking ability with or without walking aid
  • experienced at least one fall during the last 12 months
  • ability to communicate and cooperate with study staff

Exclusion Criteria:

  • ongoing physiotherapy treatment
  • ongoing participation in exercise/acitivity containing balance and strength enhancing components
  • a dementia diagnose
  • mental disorder that affects possibility to communicate and cooperate
  • other medical reason making participation inte the study inappropriate.

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): NCT01705912


Locations
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Sweden
Family medicine research center
Orebro, Sweden, 701 16
Sponsors and Collaborators
Gunilla Fahlstrom
Örebro County Council
Örebro University, Sweden
Investigators
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Principal Investigator: Gunilla Fahlstrom, PhD Örebro County Council

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Responsible Party: Gunilla Fahlstrom, PhD, Örebro County Council
ClinicalTrials.gov Identifier: NCT01705912     History of Changes
Other Study ID Numbers: OLLGF01
OLLGF0112 ( Other Identifier: Orebro county council )
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012
Keywords provided by Gunilla Fahlstrom, Örebro County Council:
fall
prevention