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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 November 2016 |
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Main ID: |
NCT02926105 |
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Date of registration:
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04/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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405 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02926105 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Anne-Gabrielle Mittaz Hager, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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HES-SO Valais-Wallis |
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Name:
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Anne-Gabrielle Mittaz Hager, MS |
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Address:
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Telephone:
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+41 79 609 90 63 |
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Email:
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gaby.mittaz@hevs.ch |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Accidental Falls
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Intervention(s)
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Behavioral: T&E Home-based exercise programme
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Behavioral: Helsana booklet
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Behavioral: Otago
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Primary Outcome(s)
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number of falls
[Time Frame: one year]
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Secondary Outcome(s)
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Exercise adherence
[Time Frame: one year]
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Fear of falling
[Time Frame: one year]
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Quality of life
[Time Frame: one year]
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Risk of fall
[Time Frame: one year]
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Severity of falls
[Time Frame: one year]
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Secondary ID(s)
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CER-00931
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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