CClinicalTrials.gg
Status unknownNCT02926105SwissCHEFUpdated Nov 11, 2016

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

A Phase 3 interventional study of T&E Home-based exercise programme and Otago in Accidental Falls, sponsored by HES-SO Valais-Wallis. Status unknown at 3 sites in Switzerland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-11-11.

Sponsored by HES-SO Valais-Wallis · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
405
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Accidental Falls
03

In context

Lead sponsor

HES-SO Valais-Wallis is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
405 participants (estimated)

Study arms

  • Experimental
    T&E Home-based exercise programme

    Individually tailored home-based test and exercise programme

    Behavioral: T&E Home-based exercise programme

  • Experimental
    Otago

    Individually tailored exercise programme

    Behavioral: Otago

  • Active comparator
    Helsana booklet

    Helsana recommendations and exercises

    Behavioral: Helsana booklet

Interventions

  • BehavioralT&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.

    Also known as: T&E

  • BehavioralOtago

    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.

  • BehavioralHelsana booklet

    Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.

    Also known as: Helsana

06

What researchers measure

Primary outcomes

  1. number of falls

    Time frame: one year

Secondary outcomes

  1. Fear of falling

    FES-I

    Time frame: one year

  2. Severity of falls

    Scale of Schwenk 2012

    Time frame: one year

  3. Risk of fall

    Algorithm STEADI

    Time frame: one year

  4. Quality of life

    OPQOL-35

    Time frame: one year

  5. Exercise adherence

    Monthly calender

    Time frame: one year

07

Study locations

3 of 3 sites recruiting
  • HES-SO Valais-Wallis
    Leukerbad, Valais 3954, Switzerland
    • Nicolas Mathieu, MS · Contact · nicolas.mathieu@hevs.ch · +41 79 300 44 31
    • Annick Bonvin · Contact
    • Martin Plaschy, MA · Sub investigator
    • Nicole Gay-Balmaz, BS · Sub investigator
    • Anne-Gabrielle Mittaz Hager, MS · Principal investigator
    Recruiting
  • CUTR Sylvana
    Epalinges, Vaud 1066, Switzerland
    Recruiting
  • Physiotherapie Nevzati
    Zurich, 8032, Switzerland
    Recruiting
08

References and documents

Publications

  • 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. PubMed 30642252 ↗

Related links

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02926105
Lead sponsor
HES-SO Valais-Wallis
Collaborators
Fondation Leenaards, Switzerland
Responsible party
Sponsor
First posted
Oct 6, 2016
Start date
Oct 2016
Primary completion
Oct 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Nov 11, 2016

Study contacts

Anne-Gabrielle Mittaz Hager, MS
Contact
gaby.mittaz@hevs.ch
+41 79 609 90 63
Roger Hilfiker, MS
Contact
roger.hilfiker@hevs.ch
+41 79 688 34 90
Anne-Gabrielle Mittaz Hager, MS
principal investigator · HES-SO Valais-Wallis

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion