NCT02926105

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
405

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2016

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

October 4, 2016

Last Update Submit

November 10, 2016

Conditions

Accidental Falls

Outcome Measures

Primary Outcomes (1)

  • number of falls

    one year

Secondary Outcomes (5)

  • Fear of falling

    one year

  • Severity of falls

    one year

  • Risk of fall

    one year

  • Quality of life

    one year

  • Exercise adherence

    one year

Study Arms (3)

T&E Home-based exercise programme

EXPERIMENTAL

Individually tailored home-based test and exercise programme

Behavioral: T&E Home-based exercise programme

Otago

EXPERIMENTAL

Individually tailored exercise programme

Behavioral: Otago

Helsana booklet

ACTIVE COMPARATOR

Helsana recommendations and exercises

Behavioral: Helsana booklet

Interventions

T&E Home-based exercise programmeBEHAVIORAL

"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
T&E Home-based exercise programme
OtagoBEHAVIORAL

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.

Otago
Helsana bookletBEHAVIORAL

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

Also known as: Helsana
Helsana booklet

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CUTR Sylvana

Épalinges, Canton of Vaud, 1066, Switzerland

RECRUITING

Physiotherapie Nevzati

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

HES-SO Valais-Wallis

Leukerbad, Valais, 3954, Switzerland

RECRUITING

Related Publications (2)

  • Hager AM, Mathieu N, Carrard S, Bridel A, Wapp C, Hilfiker R. Partially supervised exercise programmes for fall prevention improve physical performance of older people at risk of falling: a three-armed multi-centre randomised controlled trial. BMC Geriatr. 2024 Apr 3;24(1):311. doi: 10.1186/s12877-024-04927-0.

    PMID: 38570773DERIVED

  • 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.

    PMID: 30642252DERIVED

Related Links

Study Officials

  • Anne-Gabrielle Mittaz Hager, MS

    HES-SO Valais-Wallis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Gabrielle Mittaz Hager, MS

CONTACT

+41 79 609 90 63gaby.mittaz@hevs.ch

Roger Hilfiker, MS

CONTACT

+41 79 688 34 90roger.hilfiker@hevs.ch

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 6, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

November 11, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

CH(3)