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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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16 December 2017 |
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Main ID: |
NCT03019211 |
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Date of registration:
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08/01/2017 |
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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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Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly
PrePhysFalls |
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Scientific title:
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Feasibility of a Physical Exercise Program, Performed Inside or Outside the Aquatic Environment, to Reduce Falls in Institutionalized Elderly: A Pilot Randomised Clinical Study |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03019211 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Mercè Sitjà Rabert, PhD, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Ramon Llull |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Be institutionalized in a care center
- Participate voluntarily and sign the informed consent
- Have a punctuation of 2 or more in The Downton Fall Risk Index
Exclusion Criteria:
- Suffer from a condition that can be affected or hinder exercise
- Acute disease unresolved in 10 days
- Not controlled hypertension
- Contagious skin disorder
- Urinary or faecal incontinence
Age minimum:
65 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cognitive Impairment
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Age Problems
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Strength
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Elderly
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Postural Balance
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Intervention(s)
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Other: Exercise
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Primary Outcome(s)
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Change from baseline Number of Falls at 3 months, 6 months and 9 months
[Time Frame: 3 months, 6 months, 9 months]
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Secondary Outcome(s)
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Intervention Perception measured with Qualitative interview
[Time Frame: 3 months]
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Balance measured with Performance Oriented Mobility Assessment
[Time Frame: 3 months, 6 months, 9 months]
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Mobility measured with Timed Up & Go Test
[Time Frame: 3 months, 6 months, 9 months]
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Daily living activities measured with Barthel Test
[Time Frame: 3 months, 6 months, 9 months]
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Muscle strength measured with Five Sit to Stand test and Handgrip Test
[Time Frame: 3 months, 6 months, 9 months]
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Pain measured with Visual Analogue Scale
[Time Frame: 3 months, 6 months, 9 months]
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Secondary ID(s)
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PrePhysFalls
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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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