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Completed

NCT Number: NCT01705912

Fall Prevention Among Community Living Elderly

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.

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Key information

Conditions

Accidental Falls/Prevention and Control

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family medicine research center

Örebro, 701 16, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Complete intervention

Other

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.

basic intervention

Other

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 outcomes

  1. Number of days with fall

    Time frame: 12 months

    Self reported calendar data

Secondary outcomes

  1. Exercise

    Time frame: 12 months

    Self reported calendar data

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Gunilla Fahlstrom

Other Gov

Collaborators

  • Örebro County Council
  • Örebro University, Sweden

Registry information

Official study title

Fall Prevention by Assistant Nurses Among Community Living Elderly With Risk of Falling - a Randomized Controlled Trial

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 12, 2012
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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