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

Phase 3

• Conditions: Accidental Falls
• Interventions: Behavioral: T&E Home-based exercise programme; Behavioral: Otago; Behavioral: Helsana booklet

• Registration Number: NCT02926105
• Lead Sponsor: HES-SO Valais-Wallis

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-11
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 405

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T&E Home-based exercise programme	T&E Home-based exercise programme	Individually tailored home-based test and exercise programme
Otago	Otago	Individually tailored exercise programme
Helsana booklet	Helsana booklet	Helsana recommendations and exercises

Primary Outcome Measures

Name	Time	Method
number of falls	one year

Secondary Outcome Measures

Name	Time	Method
Quality of life	one year	OPQOL-35
Severity of falls	one year	Scale of Schwenk 2012
Exercise adherence	one year	Monthly calender
Risk of fall	one year	Algorithm STEADI
Fear of falling	one year	FES-I

Trial Locations

Locations (3)

Physiotherapie Nevzati; 🇨🇭 Zurich, Switzerland

CUTR Sylvana; 🇨🇭 Epalinges, Vaud, Switzerland

HES-SO Valais-Wallis; 🇨🇭 Leukerbad, Valais, Switzerland