Falls Prevention in Older Home Care Recipients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Accidental Falls

Intervention / Treatment
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* Other: Exercise and education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and education<br>This group performs a 12-week individual tailored home exercise programme in accordance with the manual of Otago exercise programme. Physiotherapists visit the participants 5 times during the 12 weeks (at week 1,2,4,8 and 10) to prescribe and progress exercises. Motivational conversations on telephone are performed the weeks when no visits are scheduled. Additionally, the participants receive information on the first visit which will focus on motivation, importance of adherence and effectiveness of falls prevention. The participants are expected to do exercises on their own, and in that way perform exercises 3 times weekly. If safe, the participant are provided with a walking plan and be encouraged to walk twice weekly. | Other: Exercise and education<br>* Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.<br>|
| No Intervention: Control<br>The control group performs activities as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 Health Survey Summary Scores | 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. | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D | 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. | Baseline, 3 months, 6 months | 
| Berg Balance Scale | 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) | Baseline, 3 months, 6 months | 
| Sit-to-stand Test | 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. | Baseline, 3 months, 6 months | 
| 4-meter Walk Test | 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 | Baseline, 3 months, 6 months | 
| Falls Efficacy Scale - International | 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. | Baseline, 3 months, 6 months | 
| Instrumental Activities of Daily Living | 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). | Baseline, 3-months, 6-months | 
| Walking Habits | Questions regarding walking habits in the last 7 days. Summarized in total minutes walking. | Baseline, 3 months, 6 months | 
| Mini Nutritional Assessment | The summary score of the Mini Nutritional Assessment (MNA) maps to three nutritional statuses Normal nutritional status, Risk of malnutrition and being Malnourished. | Baseline, 3 months, 6 months | 
| Exercise According to the Protocol. Adherence | 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. | Baseline and 3 months | 
| No. of Participants Exercising Post-intervention | Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up. | 3 months and 6 months | 
| No. of Falls | 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. | 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls, Home care, Older people, Falls prevention, Quality of life, Exercise, Balance, Preventative care, Community health services, Home-help services