Clinical trial NCT02926105: Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Accidental Falls
Lead sponsor: HES-SO Valais-Wallis
Sponsor class: OTHER
Collaborators: name: Fondation Leenaards, Switzerland
First posted: 2016-10-06
Enrollment: 405
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: number of falls
timeFrame: one year
Secondary outcomes:
measure: Fear of falling
timeFrame: one year
measure: Severity of falls
timeFrame: one year
measure: Risk of fall
timeFrame: one year
measure: Quality of life
timeFrame: one year
measure: Exercise adherence
timeFrame: one year
Other outcomes:
Locations:
city: Leukerbad
country: Switzerland
facility: HES-SO Valais-Wallis
state: Valais
city: Epalinges
country: Switzerland
facility: CUTR Sylvana
state: Vaud
city: Zurich
country: Switzerland
facility: Physiotherapie Nevzati
Study officials:
affiliation: HES-SO Valais-Wallis
name: Anne-Gabrielle Mittaz Hager, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mittaz Hager AG, Mathieu N, Lenoble-Hoskovec C, Swanenburg J, de Bie R, Hilfiker R. 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 randomized controlled trial. BMC Geriatr. 2019 Jan 14;19(1):13. doi: 10.1186/s12877-018-1021-y.