Accidental FallsFALLFORNCT01313481
Effect of the Otago Programme Delivered as Home Exercise or Group Exercise
A study testing Group exercise and Home exercise in people with Accidental Falls and Distorted Balance, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The study aims to assess the effect on functional balance of Otago exercise performed as home exercise versus group exercise. The investigators hypothesize that Otago exercise is more effective performed as group exercise than home exercise. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls, Distorted Balance
- What is being tested?
- Group exercise and Home exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2008to Oct 2011
- 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
- referred to an outpatient falls clinic
- have fallen previous year or have gait or balance problems
Who cannot join
- Mini Mental Status Examination (MMSE) < 22
- Not able to walk 10 m without support from another person
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of the Effect of Otago Exercise Delivered as Home Exercise or Group Exercise in Fall-prone Older Persons
The study aims to assess the effect on functional balance of Otago exercise performed as home exercise versus group exercise. The investigators hypothesize that Otago exercise is more effective performed as group exercise than home exercise.
Read the detailed description
The study sample is drawn from persons referred to a falls outpatient clinic. Group exercise and home exercise are delivered by trained physiotherapists. Home exercise follows the original Otago exercise protocol. Group exercise is performed twice a week. The length of the intervention period is 3 months. The main outcome measure is the Berg Balance Scale.
- Conditions
- Accidental Falls, Distorted Balance
- Being tested
- Group exercise, Home exercise
- Keywords
- Older persons, Exercise, Balance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group exerciseBehavioural
Otago exercise performed in groups of 4-8 patients, 2 times a week over 12 weeks
Home exerciseBehavioural
Otago exercise performed as home exercise 3 times a weeks over 12 weeks. Individually tailored physical balance and muscle strength exercise
| Study group | Role | What they receive |
|---|---|---|
| Group exercise | Experimental | Otago exercise performed in groups Receives: Behavioral: Group exercise |
| Home exercise | Active comparator | Otago exercise performed as home exercise Receives: Behavioral: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Balance by use of the Berg Balance Scale
Measured: 3 months
Secondary outcomes (4)
Fear of falling by the Fall Efficacy Scale International (FES-I), 7 item version
Measured: 3 and 6 months
Mobility by the Timed Get up-and-go
Measured: 3 and 6 months
Functional leg muscle strength by a Sit-to-stand test
Number of raise-up trials in 30 sec, picked from the Senior Fitness test
Measured: 3 and 6 months
Health related quality of life by the Short Formular 36 (SF-36)
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionOct 2011
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 FallsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Sponsor
- Investigators
- Jorunn L Helbostad, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313481
- Sponsor's protocol ID
- 6.2008.1352
- Acronym
- FALLFOR
- Status last verified
- Jul 2016
- First submitted
- 22 Mar 2010
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.
PubMed 24339273
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effect of Otago Exercise Delivered as Home Exercise or Group Exercise in Fall-prone Older Persons
- ClinicalTrials.gov ID
- NCT01313481
- Acronym / sponsor ID
- FALLFOR / 6.2008.1352
- Conditions
- Accidental Falls, Distorted Balance
- Keywords
- Older persons, Exercise, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Mar 2011 (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 study aims to assess the effect on functional balance of Otago exercise performed as home exercise versus group exercise. The investigators hypothesize that Otago exercise is more effective performed as group exercise than home exercise.
Detailed description
The study sample is drawn from persons referred to a falls outpatient clinic. Group exercise and home exercise are delivered by trained physiotherapists. Home exercise follows the original Otago exercise protocol. Group exercise is performed twice a week. The length of the intervention period is 3 months. The main outcome measure is the Berg Balance Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group exercise | Experimental | Behavioral: Group exerciseOtago exercise performed in groups |
| Home exercise | Active comparator | Behavioral: Home exerciseOtago exercise performed as home exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- referred to an outpatient falls clinic
- have fallen previous year or have gait or balance problems
Key exclusion criteria (2 listed)
- Mini Mental Status Examination (MMSE) < 22
- Not able to walk 10 m without support from another person
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 |
|---|---|---|
| Group exerciseOtago exercise performed in groups of 4-8 patients, 2 times a week over 12 weeks | Behavioural | Group exercise |
| Home exerciseOtago exercise performed as home exercise 3 times a weeks over 12 weeks. Individually tailored physical balance and muscle strength exercise | Behavioural | Home exercise |
Primary outcome
Functional Balance by use of the Berg Balance Scale
Time frame: 3 months
4 secondary outcomes
Fear of falling by the Fall Efficacy Scale International (FES-I), 7 item version
Time frame: 3 and 6 months
Mobility by the Timed Get up-and-go
Time frame: 3 and 6 months
Functional leg muscle strength by a Sit-to-stand test
Time frame: 3 and 6 months
Health related quality of life by the Short Formular 36 (SF-36)
Time frame: 3 and 6 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 19 Jul 2016.
- Results publication: PubMed 24339273Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.
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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.
Jorunn L Helbostad, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group exercise and Home exercise in people with Accidental Falls and Distorted Balance, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 2 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 19 Jul 2016. 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 Norway. 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?
Functional Balance by use of the Berg Balance Scale (time frame: 3 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 NCT01313481, 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 19 Jul 2016.