Accidental Falls/Prevention & ControlPhase 4NCT01032252
Prevention of Falls in General Practitioner for Community-dwelling Older Adults [PreFalls]
A Phase 4 study testing Exercise intervention in people with Accidental Falls/Prevention & Control and Risk Assessment, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The primary aim of this two-year project for falls prevention is to reduce number of falls and fall incidence in community-dwelling people of 65 years and older in the setting of general practitioners. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls/Prevention & Control, Risk Assessment, General Practitioner Education
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Mar 2012
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Target group are community-dwelling senior citizens aged 65 years or above with an increased risk of falling.
- Increased risk of falling are seen by:
- history of falls
- fear of falling
- chair rise > 10 sec./TUG > 10 sec./ subjective \& objective balance deficits
Who cannot join
- Elderly people not living independently or suffering from physical or mental restrictions that do not allow the participation in an exercise program or the assessment of risk of falling
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Munich, 80809
About this study
Official title: Prevention of Falls in Community-dwelling Older Adults by a Standardized Assessment of Fall Risks in the General Practitioner Setting and Through Implementation of a Network for Effective Individual Reduction on Fall Risks.
The primary aim of this two-year project for falls prevention is to reduce number of falls and fall incidence in community-dwelling people of 65 years and older in the setting of general practitioners. In addition a reduction of fall-related injuries, reduction of fall-related risk factors and preservation of Quality of Life is to be achieved.
A second goal of this study is the implementation of standardized assessment for fall risk factors as well as building up a network between instructors for fall prevention exercise and general practitioners.
Read the detailed description
Health related consequences of falls are underestimated. In comparison to different health related risk factors like hypertension etc. falls and their risks are being underestimated by many physicians. Regardless of the high relevance of falls for the elderly as well as the Health Care System, risk of falling is only rarely being assessed. The reasons for this are manifold. Insufficient assessment of risk of falling are one of the reasons. Many registered doctors with their own practice do not use a standardized assessment of risk of falling that is quick and effective. Additionally, patients rarely report occurred falls to their physicians because they don't know the implications or are afraid of subsequently losing their independence.
Physicians already assessing their senior patients' risk of falling lack the possibility to assign them to according ambulatory interventions since these scarcely exist in Bavaria. Chances for improvement are: standardized assessment of risk of falling needed to uncover senior patients' risk of falling quickly, reliably and efficiently at their family physician's. At the same time area-wide programs to effectively reduce falls by targeting individual behavior as well as general conditions must be provided to maintain the independence of individual senior citizens.
- Conditions
- Accidental Falls/Prevention & Control, Risk Assessment, General Practitioner Education, Humans, Multicenter Study, Randomized Controlled Trial
- Being tested
- Exercise intervention
- Keywords
- fall prevention, general practitioners setting, implementation, network, community dwelling older adults, exercise intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16 week exercise once a week of 60 minutes intervention by trained fall prevention instructors and a home program.
Intervention includes strength/power training, balance/gait training, behavioral aspects and perceptual and functional training.
| Study group | Role | What they receive |
|---|---|---|
| observational | No intervention | Control group: followed by monthly falls calenders and four testing periods |
| Exercise group | Experimental | 16 week intervention, and followed by monthly fall calenders as well as 4 testing periods Receives: Other: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars
Measured: 24 months
Secondary outcomes (1)
Secondary endpoints are a reduction in fear of falling, a reduction in risk of falling in the physical dimensions e.g. strength, balance and function, the preservation of quality of life and the preservation or increase in physical activity.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental Falls/Prevention & ControlStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Responsible party
- Sponsor
- Investigators
- Monika Siegrist, PhD, Principal investigator, Department of Medicine, Division of Prevention and Sports Medicine TU MunichEllen Freiberger, PhD, Principal investigator, Department of Sport Science, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032252
- Sponsor's protocol ID
- FAU061209TUM
- Other IDs
- FAU061209TUM
- Status last verified
- Dec 2020
- First submitted
- 12 Dec 2009
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Blank WA, Freiberger E, Siegrist M, Landendoerfer P, Linde K, Schuster T, Pfeifer K, Schneider A, Halle M. An interdisciplinary intervention to prevent falls in community-dwelling elderly persons: protocol of a cluster-randomized trial [PreFalls]. BMC Geriatr. 2011 Feb 17;11:7. doi: 10.1186/1471-2318-11-7.
PubMed 21329525
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Falls in Community-dwelling Older Adults by a Standardized Assessment of Fall Risks in the General Practitioner Setting and Through Implementation of a Network for Effective Individual Reduction on Fall Risks.
- ClinicalTrials.gov ID
- NCT01032252
- Acronym / sponsor ID
- FAU061209TUM
- Conditions
- Accidental Falls/Prevention & Control, Risk Assessment, General Practitioner Education, Humans, Multicenter Study, Randomized Controlled Trial
- Keywords
- fall prevention, general practitioners setting, implementation, network, community dwelling older adults, exercise intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Dec 2009 (estimated)
- 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.
The primary aim of this two-year project for falls prevention is to reduce number of falls and fall incidence in community-dwelling people of 65 years and older in the setting of general practitioners. In addition a reduction of fall-related injuries, reduction of fall-related risk factors and preservation of Quality of Life is to be achieved.
A second goal of this study is the implementation of standardized assessment for fall risk factors as well as building up a network between instructors for fall prevention exercise and general practitioners.
Detailed description
Health related consequences of falls are underestimated. In comparison to different health related risk factors like hypertension etc. falls and their risks are being underestimated by many physicians. Regardless of the high relevance of falls for the elderly as well as the Health Care System, risk of falling is only rarely being assessed. The reasons for this are manifold. Insufficient assessment of risk of falling are one of the reasons. Many registered doctors with their own practice do not use a standardized assessment of risk of falling that is quick and effective. Additionally, patients rarely report occurred falls to their physicians because they don't know the implications or are afraid of subsequently losing their independence.
Physicians already assessing their senior patients' risk of falling lack the possibility to assign them to according ambulatory interventions since these scarcely exist in Bavaria. Chances for improvement are: standardized assessment of risk of falling needed to uncover senior patients' risk of falling quickly, reliably and efficiently at their family physician's. At the same time area-wide programs to effectively reduce falls by targeting individual behavior as well as general conditions must be provided to maintain the independence of individual senior citizens.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observational | No intervention | –Control group: followed by monthly falls calenders and four testing periods |
| Exercise group | Experimental | Other: Exercise intervention16 week intervention, and followed by monthly fall calenders as well as 4 testing periods |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Target group are community-dwelling senior citizens aged 65 years or above with an increased risk of falling.
- Increased risk of falling are seen by:
Key exclusion criteria (1 listed)
- Elderly people not living independently or suffering from physical or mental restrictions that do not allow the participation in an exercise program or the assessment of risk of falling
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 |
|---|---|---|
| Exercise intervention16 week exercise once a week of 60 minutes intervention by trained fall prevention instructors and a home program. Intervention includes strength/power training, balance/gait training, behavioral aspects and perceptual and functional training. | Other | Exercise group |
Primary outcome
Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars
Time frame: 24 months
1 secondary outcome
Secondary endpoints are a reduction in fear of falling, a reduction in risk of falling in the physical dimensions e.g. strength, balance and function, the preservation of quality of life and the preservation or increase in physical activity.
Time frame: 24 months
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 14 Dec 2020.
- Background: PubMed 21329525Blank WA, Freiberger E, Siegrist M, Landendoerfer P, Linde K, Schuster T, Pfeifer K, Schneider A, Halle M. An interdisciplinary intervention to prevent falls in community-dwelling elderly persons: protocol of a cluster-randomized trial [PreFalls]. BMC Geriatr. 2011 Feb 17;11:7. doi: 10.1186/1471-2318-11-7.
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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.
Monika Siegrist, PhD principal investigator
Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Ellen Freiberger, PhD principal investigator
Department of Sport Science, University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exercise intervention in people with Accidental Falls/Prevention & Control and Risk Assessment, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 5 inclusion and 1 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 14 Dec 2020. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032252, which also lists 1 linked publication.
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 14 Dec 2020.