FallNCT04205448
Fall Prevention Study Among Seniors in Bomlo
A study testing Physical exercize in people with Fall, run by Kjersti Helen Folleso at 1 site in Norway.
Trial summary
Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests performed by physiotherapist. If risk of falling is confirmed, participants will be randomized to either intervention group with fall-preventing exercize program or to a control group. Follow-up over 5 years. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Fall
- What is being tested?
- Physical exercize
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2019to 25 Jan 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65-85, home-dwellers in Bomlo municipality, capable of following up group-exercize, informed consent.
Who cannot join
- Serious illness, in need of walking-aid indoors, moderate to severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Identification and Intervention in Risk of Falling Among Seniors i Bomlo Municipality
Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests performed by physiotherapist. If risk of falling is confirmed, participants will be randomized to either intervention group with fall-preventing exercize program or to a control group. Follow-up over 5 years.
Read the detailed description
Participants randomized to either exercise group or control group. Tests for balance and strength performed by physiotherapist at inclusion, and after three and six months and one year for both groups. Further follow-up and further inclusion of participants had to be terminated due to the pandemic in Mach 2020, when group activities were no longer allowed.
- Conditions
- Fall
- Being tested
- Physical exercize
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercizeBehavioural
10 weeks group exercize followed by community-based voluntary exercize
| Study group | Role | What they receive |
|---|---|---|
| Exercize group | Experimental | 10 weeks of physical exercise. Testing of strength and balance. Receives: Behavioral: Physical exercize |
| Control group | No intervention | Testing of strength and balance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall-related injuries
identified in electronic patient record in primary care
Measured: First year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Mar 2019
- Primary completion31 Mar 2020
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kjersti Helen Folleso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kjersti Helen Folleso, Bomlo Municipality
- Investigators
- Kjetil A Gjoesaeter, Study chair, Bomlo Municipality
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205448
- Sponsor's protocol ID
- BK-KS01
- Status last verified
- Jan 2021
- First submitted
- 18 Dec 2019
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Accepted for publication in Norwegian scientific journal "Utposten".
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification and Intervention in Risk of Falling Among Seniors i Bomlo Municipality
- ClinicalTrials.gov ID
- NCT04205448
- Acronym / sponsor ID
- BK-KS01
- Conditions
- Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kjersti Helen FollesoUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 19 Dec 2019 (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.
Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests performed by physiotherapist. If risk of falling is confirmed, participants will be randomized to either intervention group with fall-preventing exercize program or to a control group. Follow-up over 5 years.
Detailed description
Participants randomized to either exercise group or control group. Tests for balance and strength performed by physiotherapist at inclusion, and after three and six months and one year for both groups. Further follow-up and further inclusion of participants had to be terminated due to the pandemic in Mach 2020, when group activities were no longer allowed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Exercize group | Experimental | Behavioral: Physical exercize10 weeks of physical exercise. Testing of strength and balance. |
| Control group | No intervention | –Testing of strength and balance. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age 65-85, home-dwellers in Bomlo municipality, capable of following up group-exercize, informed consent.
Key exclusion criteria (1 listed)
- Serious illness, in need of walking-aid indoors, moderate to severe cognitive impairment
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 |
|---|---|---|
| Physical exercize10 weeks group exercize followed by community-based voluntary exercize | Behavioural | Exercize group |
Primary outcome
Fall-related injuries
Time frame: First year
identified in electronic patient record in primary care
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 28 Jan 2021.
- Individual participant dataSharing planned: Yes. Accepted for publication in Norwegian scientific journal "Utposten".
Related trials for Fall
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
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.
Kjetil A Gjoesaeter study chair
Bomlo Municipality
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercize in people with Fall, run by Kjersti Helen Folleso 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 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 28 Jan 2021. 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?
Fall-related injuries (time frame: First year). 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 28 Jan 2021.