- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759977
Effects of an Adapted Physical Activity on the Postural Control of Residents in Nursing Home.
April 16, 2019 updated by: Thomas Bugnon, University of Lausanne
Effects of Adapted Physical Activity on the Static and Dynamic Postural Control of Residents in Nursing Home: an Exploratory Study of 8 Weeks in the Réseau Santé de la Glâne (Canton of Fribourg, Switzerland).
This study measures the effects of an Adapted Physical Activity on postural control of residents in nursing home.
Half of participants will follow a program training 3 times a week during 8 weeks, while the other half will receive the usual accompaniment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Lausanne, Switzerland
- Université de Lausanne
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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
70 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to walk 20 meters with or without auxiliary help
- Able to stand 1 minute without help
- Health status considered stable
- Life expectancy greater than 6 months
- No major cognitive impairment preventing them from understanding a simple instruction
- No severe visual impairment
- No severe deafness
- Understanding french
- Able to discern
Exclusion Criteria:
- Unable to walk 20 meters with or without auxiliary help
- Unable to stand 1 minute without help
- Health status considered unstable
- Estimated life expectancy at less than 6 months
- Major cognitive impairment preventing them from understanding a simple instruction
- Severe visual impairment
- Severe deafness
- Not understanding french
- Inability to discern
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: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Adapted Physical Activity group
This group will receive 3 sessions per week of specific physical activity.
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The sessions of Adapted Physical Activity will be focus around the theme of balance, with a small part of resistance training.
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NO_INTERVENTION: Usual accompaniment group
This group will continue to follow the usual accompaniment of the nursing home.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postural control
Time Frame: 15 minutes
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Measures of the center of pressure under different conditions.
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15 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Habitual gait speed in meter per seconde
Time Frame: 5 minutes
|
Gait parameter
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5 minutes
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Gait variability in percentage
Time Frame: 5 minutes
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Gait parameter
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5 minutes
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Gait asymmetry in percentage
Time Frame: 5 minutes
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Gait parameter
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5 minutes
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Short Physical Performance Battery test
Time Frame: 10 minutes
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This unique test is composed of a standing balance exercise, a gait speed exercise and chair stand exercise.
It gives a score of 0 to 12. 0 is the worst performance and 12 the best one.
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10 minutes
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General quality of life
Time Frame: 5 minutes
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Euro Quality of life 5 dimensions (EQ-5D)
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5 minutes
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Depression
Time Frame: 5 minutes
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Geriatric Depression Scale 4 items.
0 (the best) to 4 (the worst) points.
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5 minutes
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Fear of falling
Time Frame: 5 minutes
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Falls Efficacy Scale International.
7 (no concern about falling) to 28 (severe concern about falling)
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5 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vincent Gremeaux, Professor, University of Lausanne
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 (ACTUAL)
January 7, 2019
Primary Completion (ACTUAL)
March 22, 2019
Study Completion (ACTUAL)
March 22, 2019
Study Registration Dates
First Submitted
November 27, 2018
First Submitted That Met QC Criteria
November 28, 2018
First Posted (ACTUAL)
November 30, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2018-01833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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