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Clinical Trials/NCT02374307
NCT02374307
Completed
N/A

Effect of a Falls-prevention Exercise Program on Health-related Quality of Life in Older Fallers Receiving Home Care. A Randomized Controlled Trial

Oslo Metropolitan University6 sites in 1 country155 target enrollmentFebruary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Accidental Falls
Sponsor
Oslo Metropolitan University
Enrollment
155
Locations
6
Primary Endpoint
Short Form 36 Health Survey Summary Scores
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The aim of this study is to investigate the effect of a falls-prevention exercise programme on health-related quality of life, fear of falling, falls and physical function in older people receiving home care. Participants in the intervention group perform the Otago exercise programme. Participants in the control group continue their usual activities.

Detailed Description

Falls and falls-related injuries are considered a serious public health issue in the older population. Strength and balance exercise in combination with information about falls prevention seems to be effective in reducing falls, but less is known about the effect of this kind of intervention on quality of life. This randomized controlled trial investigates the effect of a falls prevention program on health-related quality of life, fear of falling, falls and physical function in community-dwelling older people who receive home care.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
September 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo Metropolitan University
Responsible Party
Principal Investigator
Principal Investigator

Maria Bjerk

PhD Research Fellow

Oslo Metropolitan University

Eligibility Criteria

Inclusion Criteria

  • has fallen at least one time in the last 12 months
  • receives home-help services
  • able to walk independently indoors with or without walking aid

Exclusion Criteria

  • medical contraindication to exercise
  • life expectancy \<1 year
  • scores under 23 points on Mini Mental Scale Examination
  • participating in another falls prevention programme during the 12 weeks of the programme, for example a falls prevention group

Outcomes

Primary Outcomes

Short Form 36 Health Survey Summary Scores

Time Frame: Baseline, 3 months, 6 months

Changes in the Short Form 36 Health Survey (SF-36) summary scores from baseline to 3-months follow-up. SF-36 measures health-related quality of life. Its summary score is comprised of a physical component summary (PCS) and a mental component summary (MCS). The scores range from 0-100 (worst-best) in each scale. A positive change in the summary score indicates a better health-related quality of life.

Secondary Outcomes

  • 4-meter Walk Test(Baseline, 3 months, 6 months)
  • EQ-5D(Baseline, 3 months, 6 months)
  • Berg Balance Scale(Baseline, 3 months, 6 months)
  • Sit-to-stand Test(Baseline, 3 months, 6 months)
  • Mini Nutritional Assessment(Baseline, 3 months, 6 months)
  • No. of Participants Exercising Post-intervention(3 months and 6 months)
  • No. of Falls(3 months and 6 months)
  • Falls Efficacy Scale - International(Baseline, 3 months, 6 months)
  • Instrumental Activities of Daily Living(Baseline, 3-months, 6-months)
  • Exercise According to the Protocol. Adherence(Baseline and 3 months)
  • Walking Habits(Baseline, 3 months, 6 months)

Study Sites (6)

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