Accidental Falls/Prevention and ControlNCT01705912
Fall Prevention Among Community Living Elderly
A study testing Complete intervention and Basic intervention in people with Accidental Falls/Prevention and Control, run by Gunilla Fahlstrom at 1 site in Sweden.
Trial summary
The purpose of this study is to assess effects of a home exercise program, supervised by assistant nurses with the aim of preventing falls. Community living persons 65 years of age or older having a risk of falling were invited to participate. Participants were randomized to either training or control. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls/Prevention and Control
- What is being tested?
- Complete intervention and Basic intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2007to Dec 2009
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- community living persons at least 65 years old
- independent walking ability with or without walking aid
- experienced at least one fall during the last 12 months
- ability to communicate and cooperate with study staff
Who cannot join
- ongoing physiotherapy treatment
- ongoing participation in exercise/acitivity containing balance and strength enhancing components
- a dementia diagnose
- mental disorder that affects possibility to communicate and cooperate
- other medical reason making participation inte the study inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fall Prevention by Assistant Nurses Among Community Living Elderly With Risk of Falling - a Randomized Controlled Trial
The purpose of this study is to assess effects of a home exercise program, supervised by assistant nurses with the aim of preventing falls.
Community living persons 65 years of age or older having a risk of falling were invited to participate. Participants were randomized to either training or control.
The training program was individually designed by a physiotherapist and the 5-month program performance was supervised in the partcipants home by eight home visits from an assistant nurse.
All participants received a visit from an occupational therapist who assessed the home and, if necessary, gave advice.
Read the detailed description
Falls among elderly are a major public health problem, but preventive interventions containing physical exercise and home improvement are available.
In this study the crucial question was to test whether unlicensed staff, assistant nurses, could be used for preventive work.
Estimation of study power gave that 170 participants in each group would be needed to detect a difference in days with falls, the main outcome measure.
- Conditions
- Accidental Falls/Prevention and Control
- Being tested
- Complete intervention, Basic intervention
- Keywords
- fall, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete interventionOther
The basic intervention, an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. The intervention consisted of an individually designed home exercise program aiming at improving balance, muscle strength and walking ability. The program, which was made by the physiotherapist, should be performed three times a week. A minimum of 30 minutes of walking per week was recommended, encouring further walking on an individual basis. An assistant nurse made eight home visits to supervise, help and encourage performance of activities.
Basic interventionOther
The basic interventions was an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention.
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Complete intervention i.e. basic intervention + individual training program. Receives: Other: Complete intervention |
| Control | Active comparator | Basic intervention. Receives: Other: Basic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with fall
Self reported calendar data
Measured: 12 months
Secondary outcomes (1)
Exercise
Self reported calendar data
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startJan 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental Falls/Prevention and 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gunilla Fahlstrom
- Sponsor type
- Other government
- Collaborators
- Örebro County Council, Örebro University, Sweden
- Responsible party
- Sponsor-investigator, Gunilla Fahlstrom, Örebro County Council
- Investigators
- Gunilla Fahlstrom, PhD, Principal investigator, Örebro County Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705912
- Sponsor's protocol ID
- OLLGF01
- Other IDs
- OLLGF0112
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Prevention by Assistant Nurses Among Community Living Elderly With Risk of Falling - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01705912
- Acronym / sponsor ID
- OLLGF01
- Conditions
- Accidental Falls/Prevention and Control
- Keywords
- fall, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Gunilla FahlstromOther government
- Collaborators
- Örebro County Council, Örebro University, Sweden
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Oct 2012 (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 purpose of this study is to assess effects of a home exercise program, supervised by assistant nurses with the aim of preventing falls.
Community living persons 65 years of age or older having a risk of falling were invited to participate. Participants were randomized to either training or control.
The training program was individually designed by a physiotherapist and the 5-month program performance was supervised in the partcipants home by eight home visits from an assistant nurse.
All participants received a visit from an occupational therapist who assessed the home and, if necessary, gave advice.
Detailed description
Falls among elderly are a major public health problem, but preventive interventions containing physical exercise and home improvement are available.
In this study the crucial question was to test whether unlicensed staff, assistant nurses, could be used for preventive work.
Estimation of study power gave that 170 participants in each group would be needed to detect a difference in days with falls, the main outcome measure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: Complete interventionComplete intervention i.e. basic intervention + individual training program. |
| Control | Active comparator | Other: Basic interventionBasic intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- community living persons at least 65 years old
- independent walking ability with or without walking aid
- experienced at least one fall during the last 12 months
- ability to communicate and cooperate with study staff
Key exclusion criteria (5 listed)
- ongoing physiotherapy treatment
- ongoing participation in exercise/acitivity containing balance and strength enhancing components
- a dementia diagnose
- mental disorder that affects possibility to communicate and cooperate
- other medical reason making participation inte the study inappropriate.
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 |
|---|---|---|
| Complete interventionThe basic intervention, an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. The intervention consisted of an individually designed home exercise program aiming at improving balance, muscle strength and walking ability. The program, which was made by the physiotherapist, should be performed three times a week. A minimum of 30 minutes of walking per week was recommended, encouring further walking on an individual basis. An assistant nurse made eight home visits to supervise, help and encourage performance of activities. | Other | Training |
| Basic interventionThe basic interventions was an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. | Other | Control |
Primary outcome
Number of days with fall
Time frame: 12 months
Self reported calendar data
1 secondary outcome
Exercise
Time frame: 12 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 12 Oct 2012.
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Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology
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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.
Gunilla Fahlstrom, PhD principal investigator
Örebro County Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete intervention and Basic intervention in people with Accidental Falls/Prevention and Control, run by Gunilla Fahlstrom at 1 site in Sweden.
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 4 inclusion and 5 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 12 Oct 2012. 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 Sweden. 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?
Number of days with fall (time frame: 12 months). 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 12 Oct 2012.