Fall InjuryNCT06265480
FallFitness Fallprevention Program for Older Adults
A study testing FallFitness intervention group in people with Fall Injury and Fall, run by Dalarna University at 1 site in Sweden.
Trial summary
The overall aim with this project is to collaborate with four organisations for retired persons located in a small region of middle Sweden. The project aims to test and evaluate a newly developed group-based fall prevention exercise program regarding the effects and experiences of both leading and participating in the… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Injury, Fall, Self Efficacy
- What is being tested?
- FallFitness intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2024to 31 Dec 2025
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age
- Fluent in Swedish language in both speech and writing
Who cannot join
- Physically weak, cannot sit upright without support and/or holding up the neck in a lying position and or rolls backwards
- Coronary artery disease and unstable angina
- Recently cataract treatment
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Marina Arkkukangas
Eskilstuna, Sormland
Marina Arkkukangas, PhD, +46 (0)706468868, maau@du.se
Michail Tonkonogi, Professor, +46(0)708206435, mtn@du.se
About this study
Official title: FallFitness Fallprevention Exercise Program for Community-dwelling Older Adults
The overall aim with this project is to collaborate with four organisations for retired persons located in a small region of middle Sweden. The project aims to test and evaluate a newly developed group-based fall prevention exercise program regarding the effects and experiences of both leading and participating in the intervention. The design of the study is a randomised controlled trial including a total of 100 participants (60+), 50 participants in the intervention and 50 participants in the control group.
Read the detailed description
Research questions of interest in the project are:
- Can an eight week (eight sessions) high intensity group based fall prevention program increase strength, balance, activity level, quality of life, self-efficacy as well as reduce sedentary behavior, fear of falling and fall frequency in older adults?
- Can older adults learn fall techniques by participating in an eight-week (eight-session) high intensity group based fall prevention program?
- What experiences are there from the trained leaders and the participants in the intervention?
- How can the program be implemented in the organisations for retired persons, facilitators and barriers?
A total of at least 10 volunteers will be recruited from the organisations for retired persons and trained to be instructors of the FallFitness program. These FallFitness instructors will lead the intervention groups in the planned randomised controlled trial.
For the 50 participants randomized to the intervention group a eight program including six different central components, strength, balance, self-efficacy, motor skills, and falling technique will be introduced. Estimation of about ten participants in each group with a total of five groups are planned.
Materials needed are mainly soft judo carpets. The exercise takes place in groups and most of the exercises are done in pairs, which has been a successful concept in previously research on a similar programme, Judo4Balance.
Outcome measures of interest:
Strength, balance, quality of life, activity level, fear of falling, confidence in one's own ability to perform various activities without falling, fall frequency and falling techniques. Further a "train the trainer" approach will be evaluated for implementation and a long term perspective of fallprevention.
- Conditions
- Fall Injury, Fall, Self Efficacy
- Being tested
- FallFitness intervention group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FallFitness intervention groupOther
Eight week group-based fallprevention intervention. A total of eight session (1-hour once a week).
| Study group | Role | What they receive |
|---|---|---|
| FallFitness intervention group | Experimental | FallFitness 8-weeks exercise program, pre-and post assessment. Receives: Other: FallFitness intervention group |
| Control group | No intervention | No treatment, standard information about fall prevention, pre-and post assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function by Short Physical Performance Battery
Balance, strength and walking
Measured: Baseline and at two months follow up
Secondary outcomes (6)
Self-efficacy (balance confidence)
Falls self-efficacy
Measured: Baseline and at two months follow up
Fear of Falling
Questionnaire
Measured: Baseline and at two months follow up
EuroQoL-5 Dimension Questionnaire (EQ-5D)
Quality of life questionnaire
Measured: Baseline and at two months follow up
Fallfrequency
Falldiary every month
Measured: A total of 12 months falldiary from baseline
Falling techniques
Falling backwards and sideways
Measured: Baseline and at two months follow up
Handgrip strength
Handgrip strength measured by hand dynamometer
Measured: Baseline and at two months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Fall InjuryStudies 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
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalarna University
- Sponsor type
- University, hospital or other
- Collaborators
- Sormland County Council, Sweden
- Responsible party
- Principal investigator, Marina Arkkukangas, Dalarna University
- Investigators
- Marina Arkkukangas, PhD, Principal investigator, Dalarna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265480
- Sponsor's protocol ID
- 2023-04577-01
- Other IDs
- 2023
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arkkukangas M, Stromqvist Baathe K, Tonkonogi M, Liljeroos M. More Than Just Exercise: Older Adults' Experience of the Peer-Led Group-Based FallFitness Program. Clin Interv Aging. 2025 Jul 1;20:931-939. doi: 10.2147/CIA.S527142. eCollection 2025.
PubMed 40621091Arkkukangas M, Baathe KS, Hamilton J, Hassan A, Tonkonogi M. FallFitness exercise program provided using the train-the-trainer approach for community-dwelling older adults: a randomized controlled trial. BMC Geriatr. 2024 Nov 30;24(1):983. doi: 10.1186/s12877-024-05575-0.
PubMed 39616365
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FallFitness Fallprevention Exercise Program for Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06265480
- Acronym / sponsor ID
- 2023-04577-01
- Conditions
- Fall Injury, Fall, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dalarna UniversityUniversity, hospital or other
- Collaborators
- Sormland County Council, Sweden
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Feb 2024 (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.
The overall aim with this project is to collaborate with four organisations for retired persons located in a small region of middle Sweden. The project aims to test and evaluate a newly developed group-based fall prevention exercise program regarding the effects and experiences of both leading and participating in the intervention. The design of the study is a randomised controlled trial including a total of 100 participants (60+), 50 participants in the intervention and 50 participants in the control group.
Detailed description
Research questions of interest in the project are:
- Can an eight week (eight sessions) high intensity group based fall prevention program increase strength, balance, activity level, quality of life, self-efficacy as well as reduce sedentary behavior, fear of falling and fall frequency in older adults?
- Can older adults learn fall techniques by participating in an eight-week (eight-session) high intensity group based fall prevention program?
- What experiences are there from the trained leaders and the participants in the intervention?
- How can the program be implemented in the organisations for retired persons, facilitators and barriers?
A total of at least 10 volunteers will be recruited from the organisations for retired persons and trained to be instructors of the FallFitness program. These FallFitness instructors will lead the intervention groups in the planned randomised controlled trial.
For the 50 participants randomized to the intervention group a eight program including six different central components, strength, balance, self-efficacy, motor skills, and falling technique will be introduced. Estimation of about ten participants in each group with a total of five groups are planned.
Materials needed are mainly soft judo carpets. The exercise takes place in groups and most of the exercises are done in pairs, which has been a successful concept in previously research on a similar programme, Judo4Balance.
Outcome measures of interest:
Strength, balance, quality of life, activity level, fear of falling, confidence in one's own ability to perform various activities without falling, fall frequency and falling techniques. Further a "train the trainer" approach will be evaluated for implementation and a long term perspective of fallprevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| FallFitness intervention group | Experimental | Other: FallFitness intervention groupFallFitness 8-weeks exercise program, pre-and post assessment. |
| Control group | No intervention | –No treatment, standard information about fall prevention, pre-and post assessment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 years of age
- Fluent in Swedish language in both speech and writing
Key exclusion criteria (3 listed)
- Physically weak, cannot sit upright without support and/or holding up the neck in a lying position and or rolls backwards
- Coronary artery disease and unstable angina
- Recently cataract treatment
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 |
|---|---|---|
| FallFitness intervention groupEight week group-based fallprevention intervention. A total of eight session (1-hour once a week). | Other | FallFitness intervention group |
Primary outcome
Physical function by Short Physical Performance Battery
Time frame: Baseline and at two months follow up
Balance, strength and walking
6 secondary outcomes
Self-efficacy (balance confidence)
Time frame: Baseline and at two months follow up
Fear of Falling
Time frame: Baseline and at two months follow up
EuroQoL-5 Dimension Questionnaire (EQ-5D)
Time frame: Baseline and at two months follow up
Fallfrequency
Time frame: A total of 12 months falldiary from baseline
Falling techniques
Time frame: Baseline and at two months follow up
Handgrip strength
Time frame: Baseline and at two months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 40621091Arkkukangas M, Stromqvist Baathe K, Tonkonogi M, Liljeroos M. More Than Just Exercise: Older Adults' Experience of the Peer-Led Group-Based FallFitness Program. Clin Interv Aging. 2025 Jul 1;20:931-939. doi: 10.2147/CIA.S527142. eCollection 2025.
- Derived from this study: PubMed 39616365Arkkukangas M, Baathe KS, Hamilton J, Hassan A, Tonkonogi M. FallFitness exercise program provided using the train-the-trainer approach for community-dwelling older adults: a randomized controlled trial. BMC Geriatr. 2024 Nov 30;24(1):983. doi: 10.1186/s12877-024-05575-0.
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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.
Marina Arkkukangas, PhD principal investigator
Dalarna University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FallFitness intervention group in people with Fall Injury and Fall, run by Dalarna University 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Arkkukangas, PhD (+46 (0)706468868, maau@du.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function by Short Physical Performance Battery (time frame: Baseline and at two months follow up). 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 NCT06265480, 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 20 Feb 2024.