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

Accidental Falls Clinical Trial

— SwissCHEF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02926105
• Other study ID #: CER-00931
• Status: Recruiting
• Phase: Phase 3
• First received: October 4, 2016
• Last updated: November 10, 2016
• Start date: October 2016
• Est. completion date: October 2019

Study information

• Verified date: November 2016
• Source: HES-SO Valais-Wallis
• Contact: Anne-Gabrielle Mittaz Hager, MS
• Phone: +41 79 609 90 63
• Email: gaby.mittaz[@]hevs.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissethics
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Behavioral:
• T&E Home-based exercise programme
"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.
• Otago
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.
• Helsana booklet
Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.

Locations

Country	Name	City	State
Switzerland	CUTR Sylvana	Epalinges	Vaud
Switzerland	HES-SO Valais-Wallis	Leukerbad	Valais
Switzerland	Physiotherapie Nevzati	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
HES-SO Valais-Wallis	Fondation Leenaards, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of falls		one year	Yes
Secondary	Fear of falling	FES-I	one year	No
Secondary	Severity of falls	Scale of Schwenk 2012	one year	Yes
Secondary	Risk of fall	Algorithm STEADI	one year	No
Secondary	Quality of life	OPQOL-35	one year	No
Secondary	Exercise adherence	Monthly calender	one year	No

External Links

•   Trial homepage