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

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ClinicalTrials.gov Identifier: NCT02926105
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : November 11, 2016
Sponsor:
Collaborator:
Fondation Leenaards, Switzerland
Information provided by (Responsible Party):
HES-SO Valais-Wallis

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

Condition or disease Intervention/treatment Phase
Accidental Falls Behavioral: T&E Home-based exercise programme Behavioral: Otago Behavioral: Helsana booklet Phase 3

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  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Helsana




Primary Outcome Measures :
  1. number of falls [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Fear of falling [ Time Frame: one year ]
    FES-I

  2. Severity of falls [ Time Frame: one year ]
    Scale of Schwenk 2012

  3. Risk of fall [ Time Frame: one year ]
    Algorithm STEADI

  4. Quality of life [ Time Frame: one year ]
    OPQOL-35

  5. Exercise adherence [ Time Frame: one year ]
    Monthly calender



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926105


Contacts
Contact: Anne-Gabrielle Mittaz Hager, MS +41 79 609 90 63 gaby.mittaz@hevs.ch
Contact: Roger Hilfiker, MS +41 79 688 34 90 roger.hilfiker@hevs.ch

Locations
Switzerland
HES-SO Valais-Wallis Recruiting
Leukerbad, Valais, Switzerland, 3954
Contact: Nicolas Mathieu, MS    +41 79 300 44 31    nicolas.mathieu@hevs.ch   
Contact: Annick Bonvin         
Sub-Investigator: Martin Plaschy, MA         
Sub-Investigator: Nicole Gay-Balmaz, BS         
Principal Investigator: Anne-Gabrielle Mittaz Hager, MS         
CUTR Sylvana Recruiting
Epalinges, Vaud, Switzerland, 1066
Contact: Constanze Lenoble-Hoskovec, BS    +41 79 556 62 46    constanze.hoskovec@chuv.ch   
Contact: Isabelle Le Franc-Guégo, BS    +41 79 556 12 86    isbelle.guego@chuv.ch   
Principal Investigator: Constanze Lenoble-Hoskovec, BS         
Physiotherapie Nevzati Recruiting
Zurich, Switzerland, 8032
Contact: Jaap Swanenburg, PhD    +41 44 261 53 61    cheftrialzurich@bluewin.ch   
Sponsors and Collaborators
HES-SO Valais-Wallis
Fondation Leenaards, Switzerland
Investigators
Principal Investigator: Anne-Gabrielle Mittaz Hager, MS HES-SO Valais-Wallis

Additional Information:
Responsible Party: HES-SO Valais-Wallis
ClinicalTrials.gov Identifier: NCT02926105     History of Changes
Other Study ID Numbers: CER-00931
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes