Postural ControlNCT03759977
Effects of an Adapted Physical Activity on the Postural Control of Residents in Nursing Home.
A study testing Adapted Physical Activity in people with Postural Control, run by University of Lausanne at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postural Control
- What is being tested?
- Adapted Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jan 2019to 22 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No severe deafness
- Understanding french
- Able to discern
Who cannot join
- 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
Show all 9Show fewer
- Severe deafness
- Not understanding french
- Inability to discern
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postural Control
- Being tested
- Adapted Physical Activity
- Keywords
- adapted physical activity, nursing home, elderly, postural control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical ActivityOther
The sessions of Adapted Physical Activity will be focus around the theme of balance, with a small part of resistance training.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity group | Experimental | This group will receive 3 sessions per week of specific physical activity. Receives: Other: Adapted Physical Activity |
| Usual accompaniment group | No intervention | This group will continue to follow the usual accompaniment of the nursing home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control
Measures of the center of pressure under different conditions.
Measured: 15 minutes
Secondary outcomes (7)
Habitual gait speed in meter per seconde
Gait parameter
Measured: 5 minutes
Gait variability in percentage
Gait parameter
Measured: 5 minutes
Gait asymmetry in percentage
Gait parameter
Measured: 5 minutes
Short Physical Performance Battery test
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.
Measured: 10 minutes
General quality of life
Euro Quality of life 5 dimensions (EQ-5D)
Measured: 5 minutes
Depression
Geriatric Depression Scale 4 items. 0 (the best) to 4 (the worst) points.
Measured: 5 minutes
Fear of falling
Falls Efficacy Scale International. 7 (no concern about falling) to 28 (severe concern about falling)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start7 Jan 2019
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- pre- posttest with control group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Bugnon, University of Lausanne
- Investigators
- Vincent Gremeaux, Professor, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759977
- Sponsor's protocol ID
- 2018-01833
- Other IDs
- 2018
- Status last verified
- Apr 2019
- First submitted
- 27 Nov 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT03759977
- Acronym / sponsor ID
- 2018-01833
- Conditions
- Postural Control
- Keywords
- adapted physical activity, nursing home, elderly, postural control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pre- posttest with control group
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity group | Experimental | Other: Adapted Physical ActivityThis group will receive 3 sessions per week of specific physical activity. |
| Usual accompaniment group | No intervention | –This group will continue to follow the usual accompaniment of the nursing home. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical ActivityThe sessions of Adapted Physical Activity will be focus around the theme of balance, with a small part of resistance training. | Other | Adapted Physical Activity group |
Primary outcome
Postural control
Time frame: 15 minutes
Measures of the center of pressure under different conditions.
7 secondary outcomes
Habitual gait speed in meter per seconde
Time frame: 5 minutes
Gait variability in percentage
Time frame: 5 minutes
Gait asymmetry in percentage
Time frame: 5 minutes
Short Physical Performance Battery test
Time frame: 10 minutes
General quality of life
Time frame: 5 minutes
Depression
Time frame: 5 minutes
Fear of falling
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Gremeaux, Professor principal investigator
University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity in people with Postural Control, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural control (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.