Physical ActivityNCT01778972
Fall Prevention for Old Community-dwelling People
A study testing Otago home exercise programme and Motivational interviewing plus Otago in people with Physical Activity, run by Uppsala University at 2 sites in Sweden.
Trial summary
Fall-related injuries are a major health problem in the growing older population. Most older people are not aware of that physical training can decrease the risk of falling. The aim of tha study is to investigate the effect of the Otago home exercise programme with and without motivational interviewing in… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Otago home exercise programme and Motivational interviewing plus Otago
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesSweden
- Study dates
- Nov 2012to Dec 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75 years or older, community-dwelling, in need of homecare or rollator
Who cannot join
- Cognitive impairment (below 25 on Mini Mental test) Not able to transfer independently indoors -
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Fall Prevention for Old Community-dwelling People in Uppsala, Västerås and Sörmland
Fall-related injuries are a major health problem in the growing older population. Most older people are not aware of that physical training can decrease the risk of falling. The aim of tha study is to investigate the effect of the Otago home exercise programme with and without motivational interviewing in community-dwelling people 75 years or older on frequence of falls, fall-related injuries, physical capacity, fall-related self-efficacy, quality of life, mortality and health-related costs.
Read the detailed description
Participants in the two intervention groups will exercise at home with supervision from physiotherapist week one, two, four and eight. They will then be contacted for telephone follow-up month five, seven and twelve after the start of training. The control group is encouraged to live as usual.
All participants are assessed at baseline, after three, 12 and 24 months from inclusion in the study.
- Conditions
- Physical Activity
- Being tested
- Otago home exercise programme, Motivational interviewing plus Otago
- Keywords
- Fall prevention, Home exercise, Strength training, Balance training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago home exercise programmeOther
Otago home exercise program was designed specifically to prevent falls. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan.
The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist.
Motivational interviewing plus OtagoOther
This group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing.
| Study group | Role | What they receive |
|---|---|---|
| Otago home training programme | Experimental | Otago home exercise programme was designed specifically to prevent fall. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan.
The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist. Receives: Other: Otago home exercise programme |
| Motivational interviewing plus Otago | Experimental | This group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing. Receives: Other: Motivational interviewing plus Otago |
| Control grop | No intervention | Participants are instructed to live their ordinary lives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequence of falls will be measured with a monthly fall-calender
A fall-calender with registration of falls on a monthly bases will be used to record falls. The fall-calender should be sent in each month. Falls will be followed-up with telephone interviews.
Measured: Two year
Secondary outcomes (3)
Fall-related injuries will be measured by telephone interviews.
Measured: Two years
Physical performance will be measured with Short Physical Performance Battery (SPPB)
SPPB measures balance, functional leg strength and walking speed.
Measured: Two years
Dynamic balance will be assessed with Mini-BESTest
Mini-BESTest assess dynamic balance impairments in 14 items. The items covers a broad spectrum of performance tasks, including transitions and anticipatory postural adjustments, postural responses to to perturbation, sensory orientation and dynamic stability in gait.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, karin hellstrom, Uppsala University
- Investigators
- Karin E Hellström, PhD, Principal investigator, Uppsala UniversityAnn-Christin Johansson, PhD, Principal investigator, Mälardalens University, SwedenAnne Söderlund, Professor, Principal investigator, Mälardalens University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778972
- Sponsor's protocol ID
- Fall prevention UV
- Other IDs
- 307301
- Status last verified
- Apr 2019
- First submitted
- 16 Jan 2013
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
PubMed 39360568Arkkukangas M, Hultgren S. Implementation of motivational interviewing in a fall prevention exercise program: experiences from a randomized controlled trial. BMC Res Notes. 2019 May 14;12(1):270. doi: 10.1186/s13104-019-4309-x.
PubMed 31088557
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Prevention for Old Community-dwelling People in Uppsala, Västerås and Sörmland
- ClinicalTrials.gov ID
- NCT01778972
- Acronym / sponsor ID
- Fall prevention UV
- Conditions
- Physical Activity
- Keywords
- Fall prevention, Home exercise, Strength training, Balance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 29 Jan 2013 (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.
Fall-related injuries are a major health problem in the growing older population. Most older people are not aware of that physical training can decrease the risk of falling. The aim of tha study is to investigate the effect of the Otago home exercise programme with and without motivational interviewing in community-dwelling people 75 years or older on frequence of falls, fall-related injuries, physical capacity, fall-related self-efficacy, quality of life, mortality and health-related costs.
Detailed description
Participants in the two intervention groups will exercise at home with supervision from physiotherapist week one, two, four and eight. They will then be contacted for telephone follow-up month five, seven and twelve after the start of training. The control group is encouraged to live as usual.
All participants are assessed at baseline, after three, 12 and 24 months from inclusion in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Otago home training programme | Experimental | Other: Otago home exercise programmeOtago home exercise programme was designed specifically to prevent fall. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist. |
| Motivational interviewing plus Otago | Experimental | Other: Motivational interviewing plus OtagoThis group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing. |
| Control grop | No intervention | –Participants are instructed to live their ordinary lives. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 75 years or older, community-dwelling, in need of homecare or rollator
Key exclusion criteria (1 listed)
- Cognitive impairment (below 25 on Mini Mental test) Not able to transfer independently indoors -
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 |
|---|---|---|
| Otago home exercise programmeOtago home exercise program was designed specifically to prevent falls. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist. | Other | Otago home training programme |
| Motivational interviewing plus OtagoThis group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing. | Other | Motivational interviewing plus Otago |
Primary outcome
Frequence of falls will be measured with a monthly fall-calender
Time frame: Two year
A fall-calender with registration of falls on a monthly bases will be used to record falls. The fall-calender should be sent in each month. Falls will be followed-up with telephone interviews.
3 secondary outcomes
Fall-related injuries will be measured by telephone interviews.
Time frame: Two years
Physical performance will be measured with Short Physical Performance Battery (SPPB)
Time frame: Two years
Dynamic balance will be assessed with Mini-BESTest
Time frame: Two years
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 29 Sep 2021.
- Derived from this study: PubMed 39360568Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
- Derived from this study: PubMed 31088557Arkkukangas M, Hultgren S. Implementation of motivational interviewing in a fall prevention exercise program: experiences from a randomized controlled trial. BMC Res Notes. 2019 May 14;12(1):270. doi: 10.1186/s13104-019-4309-x.
- 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.
Karin E Hellström, PhD principal investigator
Uppsala University
Ann-Christin Johansson, PhD principal investigator
Mälardalens University, Sweden
Anne Söderlund, Professor principal investigator
Mälardalens University, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago home exercise programme and Motivational interviewing plus Otago in people with Physical Activity, run by Uppsala University at 2 sites 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 1 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 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Frequence of falls will be measured with a monthly fall-calender (time frame: Two year). 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 NCT01778972, which also lists 2 linked publications.
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 29 Sep 2021.