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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 : Unknown
Verified November 2016 by HES-SO Valais-Wallis.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE October 4, 2016
First Posted Date  ICMJE October 6, 2016
Last Update Posted Date November 11, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
number of falls [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
  • Fear of falling [ Time Frame: one year ]
    FES-I
  • Severity of falls [ Time Frame: one year ]
    Scale of Schwenk 2012
  • Risk of fall [ Time Frame: one year ]
    Algorithm STEADI
  • Quality of life [ Time Frame: one year ]
    OPQOL-35
  • Exercise adherence [ Time Frame: one year ]
    Monthly calender
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Accidental Falls
Intervention  ICMJE
  • 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
  • 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.
  • Behavioral: Helsana booklet
    Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.
    Other Name: Helsana
Study Arms  ICMJE
  • Experimental: T&E Home-based exercise programme
    Individually tailored home-based test and exercise programme
    Intervention: Behavioral: T&E Home-based exercise programme
  • Experimental: Otago
    Individually tailored exercise programme
    Intervention: Behavioral: Otago
  • Active Comparator: Helsana booklet
    Helsana recommendations and exercises
    Intervention: Behavioral: Helsana booklet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 10, 2016)
405
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2016)
404
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02926105
Other Study ID Numbers  ICMJE CER-00931
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party HES-SO Valais-Wallis
Study Sponsor  ICMJE HES-SO Valais-Wallis
Collaborators  ICMJE Fondation Leenaards, Switzerland
Investigators  ICMJE
Principal Investigator: Anne-Gabrielle Mittaz Hager, MS HES-SO Valais-Wallis
PRS Account HES-SO Valais-Wallis
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP