Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults

Study Overview
=================
Brief Summary
-----------------
This study compares the effects of three home-based exercise programmes in at-risk to falling older adults living in their own home on the incidence of falls (number and severity), risk factors, and quality of life as well as on the adherence to exercise. The subjects will be randomized and allocated in three groups. The group A will receive the Test-and-Exercise home-based programme (T&E), the group B will receive the Otago home-based exercise programme and the group C (activ-control group) will receive the Helsana booklet

Detailed Description
-----------------
Home-based exercise programmes appear to reduce rate of falls, number of fallers, risk of falling and risk of death and to improve balance, leg strength, function, physical activity and balance confidence in older adults living in the community. The Test-and-Exercise home-based programme (T&E) contains 50 tests and 50 exercises to improve balance, strength and ability in older adults. It is especially built for older adults and is based on the concept of self-efficacy and empowerment. The originality of this programme is the evaluation of the difficulty perceived of the balance-exercises. It is delivered on a booklet which investigators had good experience with in our pilot study, with pictures and descriptions of each test and each exercise. Investigators also developed a mobile application. This application will be transmitted on a tablet-computer. In addition, the participants will receive cards with pictures of the exercises, to put into a plastic sheet to have an overview of their own exercise programme. This programme will be implemented from especially trained physiotherapists. The Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time. The Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time.

Official Title
-----------------
Comparison of the Effects of Three Home-based Exercise Programmes Regarding Falls, Quality of Life and Exercise-adherence in Older Adults at Risk of Falling: Protocol for a Randomised Controlled Trial

Conditions
-----------------
Accidental Falls

Intervention / Treatment
-----------------
* Behavioral: T&E Home-based exercise programme
* Behavioral: Otago
* Behavioral: Helsana booklet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years old and older, Living in their own home, Having a history of fall in the previous 12 months or perceiving fear of falling (≥ 20 points on FES-I, Being able to walk without auxiliary tools in their home. Signed Informed Consent Exclusion Criteria: Having severe vision impairment that do not permit the reading of the exercise-programme booklet and that do not permit the completing of the monthly diaries, Receiving physiotherapeutic treatment with balance learning, Having cognitive impairment (<25 points on the Mini-Mental State Examination (MMSE) of Folstein

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T&E Home-based exercise programme<br>Individually tailored home-based test and exercise programme | Behavioral: T&E Home-based exercise programme<br>* T&E exercises programme consists of home-based individually tailored balance and functional strength tests and exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months.<br>* Other names: T&E;|
| Experimental: Otago<br>Individually tailored exercise programme | Behavioral: Otago<br>* Otago exercises programme consists of home-based individually tailored balance, strength and walking exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months.<br>|
| Active Comparator: Helsana booklet<br>Helsana recommendations and exercises | Behavioral: Helsana booklet<br>* Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.<br>* Other names: Helsana;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of falls |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of falling | FES-I | one year | 
| Severity of falls | Scale of Schwenk 2012 | one year | 
| Risk of fall | Algorithm STEADI | one year | 
| Quality of life | OPQOL-35 | one year | 
| Exercise adherence | Monthly calender | one year |