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

November 10, 2016 updated by: HES-SO Valais-Wallis

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

405

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Anne-Gabrielle Mittaz Hager, MS
  • Phone Number: +41 79 609 90 63
  • Email: gaby.mittaz@hevs.ch

Study Contact Backup

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • Recruiting
        • Physiotherapie Nevzati
        • Contact:
    • Valais
      • Leukerbad, Valais, Switzerland, 3954
        • Recruiting
        • HES-SO Valais-Wallis
        • Contact:
        • Contact:
          • Annick Bonvin
        • Sub-Investigator:
          • Martin Plaschy, MA
        • Sub-Investigator:
          • Nicole Gay-Balmaz, BS
        • Principal Investigator:
          • Anne-Gabrielle Mittaz Hager, MS
    • Vaud
      • Epalinges, Vaud, Switzerland, 1066
        • Recruiting
        • CUTR Sylvana
        • Contact:
        • Contact:
        • Principal Investigator:
          • Constanze Lenoble-Hoskovec, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T&E Home-based exercise programme
Individually tailored home-based test and exercise programme
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.
Other Names:
  • T&E
Experimental: Otago
Individually tailored exercise programme
Behavioral: 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.
Active Comparator: Helsana booklet
Helsana recommendations and exercises
Behavioral: Helsana booklet
Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.
Other Names:
  • Helsana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of falls
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of falling
Time Frame: one year
FES-I
one year
Severity of falls
Time Frame: one year
Scale of Schwenk 2012
one year
Risk of fall
Time Frame: one year
Algorithm STEADI
one year
Quality of life
Time Frame: one year
OPQOL-35
one year
Exercise adherence
Time Frame: one year
Monthly calender
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HES-SO Valais-Wallis

Collaborators

Fondation Leenaards, Switzerland

Investigators

  • Principal Investigator: Anne-Gabrielle Mittaz Hager, MS, HES-SO Valais-Wallis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CER-00931

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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