Home-based Program T&E for Fall Prevention and QoL in Elderly: a Randomised Control Pilot-study

Study Overview
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Brief Summary
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The aim of the pilot-study is to evaluate the feasability of a future RCT, regarding recruitement of eligible participants, adhesion rate, datarecording and cost. In this feasibility pilot study, 18 patients with at least 65 years will be allocated randomly to one of two interventions. The control group gets a well-known home-based exercise program (OTAGO) aiming to prevent falls where the exercises are prescribed by a physical therapists. The exercises will be presented on a booklet and on printed cards. The Intervention group consists of an exercise program, the T&E program, where the elderly persons can choose the exercises depending on their abilities. The exercises in the T&E program will be presented in a printed manual and shown on videos on an electronic tablet. Both intervention groups receive 6 hours of instruction and control/supervision sessions by physical therapists. In addition, the participants will exercise alone. The interventions will be performed over 24 weeks. In this pilot study, the hypothesis is that the adhesion rate is at least 65%. Other feasibility criteria will be costs, data recording issues and the qualitative evaluation of the booklet and the tablet. Falls will be assessed with a falls calendar. The amount of physical activity of the participants is assessed with an accelerometers (actigraph) and quality of life will be assessed with OPQOL-35 at baseline, week 16 and week 24.

Official Title
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Tests and Exercises Home-based Program T&E for Fall Prevention and Quality of Life in Elderly: a Randomised Control Pilot-study

Conditions
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Accidental Falls

Intervention / Treatment
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* Other: T&E
* Other: OTAGO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living at home Ability to perform standing position independently with/without walking aids (rollator crutch) Reported fall(s) during the last 12 months and/or fear of falling (Short FES-I ≥8) Understand french / german Exclusion Criteria: Actually in treatment with a physical therapist Participate at an other home-based programm exercises MMS Score ≥ 25.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T&E<br>Home-based exercises program T&E.This exercise program proposes 50 exercises with a booklet, cards and an electronic tablet. The participants choose their exercises on the basis of a rating scale of perception of exercise difficulty. | Other: T&E<br> <br> * Other names: Home-based exercises programm T&E;|
| Active Comparator: OTAGO<br>Programm OTAGO is a home-based exercises program. | Other: OTAGO<br> <br> * Other names: Home-based exercises program OTAGO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion rate | Feasability of a futur study about the recruting processus and adhesion rate (≥ 65%) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasability | Feasability about cost, datarecording, qualitativ evaluation of the booklet and the electronic tablet | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, home-based exercises programm