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Completed

NCT Number: NCT02374307

Falls Prevention in Older Home Care Recipients

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.

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Key information

Conditions

Accidental Falls Behavior Motor Activity

Age range

67 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Municipality of Frogn, Drøbak, Akershus, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise and Education

Other

Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.

Primary outcomes

  1. 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

  1. EQ-5D

    Time frame: Baseline, 3 months, 6 months

    Changes in the EuroQOL EQ-5D instrument indicating changes in health-related quality of life. Preference weights for United Kingdom were employed to generate utility scores ranging from -0.59 to 1. A score of 1 is associated with a health state without problems. A positive change in EQ-5D indicates a better health-related quality of life.

  2. Berg Balance Scale

    Time frame: Baseline, 3 months, 6 months

    Changes in the Berg Balance Scale (BBS), a 14-item scale applied to assess static and dynamic balance in older adults. The summary score ranges from 0 (low, wheelchair bound) to 56 (high, independent)

  3. Sit-to-stand Test

    Time frame: Baseline, 3 months, 6 months

    Changes in the no. of raises in 30 seconds. From the sitting position, the subject stands completely up, then sits completely back down, repeated for 30 seconds.

  4. 4-meter Walk Test

    Time frame: Baseline, 3 months, 6 months

    Changes in the 4-meter walk test. Participants are asked to walk a distance of 4 meters at their usual pace, measured in m/s

  5. Falls Efficacy Scale - International

    Time frame: Baseline, 3 months, 6 months

    Changes in falls-efficacy measured with the Falls Efficacy Scale - International (FES-I) derives from a self-report questionnaire, assessing concerns about falling in 16 different daily activities. The total score ranges from 16 (no concern) to 64 (high concern). A decrease in scores indicates less concerns.

  6. Instrumental Activities of Daily Living

    Time frame: Baseline, 3-months, 6-months

    No. of participants with scores on the Instrumental Activities of Daily Living (IADL) scale, Lawton and Brody. IADL is a measure of a person's self-reported ability to perform complex activities of daily living. The summary score ranges from 0 (low function, dependent) to 8 (high function, independent).

  7. Walking Habits

    Time frame: Baseline, 3 months, 6 months

    Questions regarding walking habits in the last 7 days. Summarized in total minutes walking.

  8. Mini Nutritional Assessment

    Time frame: Baseline, 3 months, 6 months

    The summary score of the Mini Nutritional Assessment (MNA) maps to three nutritional statuses "Normal nutritional status", "Risk of malnutrition" and being "Malnourished".

  9. Exercise According to the Protocol. Adherence

    Time frame: Baseline and 3 months

    No. of participants in the intervention group performing exercises according to the protocol in the intervention period until 3-months follow-up. Participant are encouraged to complete an activity diary where they note if the exercise programme has been executed as planned. If they have not completed sufficient exercises, they are supposed to make a note in the diary.

  10. No. of Participants Exercising Post-intervention

    Time frame: 3 months and 6 months

    Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up.

  11. No. of Falls

    Time frame: 3 months and 6 months

    No. of falls in the post-intervention period between 3-months follow-up and 6-months follow-up. Falls are defined as an event, i.e. fall, trip, slip, which results in the person coming to rest on the ground or floor or other lower level.

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2015
Registry last updated
Nov 14, 2019

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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