Falls PreventionNCT05615077
Multidisciplinary Combined Exercise and Education Intervention for Falls in Older Adults
A study testing Combined exercise-education intervention in people with Falls Prevention, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to demonstrate the effect of combined exercise-education intervention in old adults with fall risk. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-education intervention with conventional medical care. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Falls Prevention
- What is being tested?
- Combined exercise-education intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Nov 2022to 31 May 2026
- 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 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients older than 65 years and under 90 years
- if at least one <3 key question> is met or <stay independent score> ≥ 4 points
- patients who can walk more than 10m without an assistive device (ambulatory without an assistive device)
- patients who are willing to participate in exercise intervention for 12 months
- patients who can receive information about this study, submit written consent before participating in the study, and can comply with the requirements of the clinical trial
Who cannot join
- medically unstable conditions (e.g., cirrhosis with complications, end-stage renal failure requiring regular dialysis, hemorrhagic disease, uncontrolled hypertension, those who have been treated for a malignant tumor within 5 years)
- in case of ongoing neurological deficit except for stroke survivors (e.g., dementia, Alzheimer's disease, Parkinson's disease, etc.)
- decreased cardiopulmonary function such as heart failure, chronic obstructive pulmonary disease
- musculoskeletal problems that affect physical function and athletic ability (e.g., those who have undergone hip joint surgery, artificial joint surgery, spine surgery within the last 1 year)
- patients who have experienced alcohol abuse within the last 1 year (if 3 or more are meet in Cut off, Annoyed, Guilty, Eye opener [CAGE] evaluation)
- in case the purpose of this clinical trial cannot be understood or the matters necessary for the study cannot be carried out
- when it is judged by other researchers that the subject's condition makes it difficult to participate in this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Keewon Kim, MD, PhD
Keewon Kim, MD, PhD
About this study
Official title: Effectiveness of Comprehensive Intervention for the Prevention of Fall in Older Adults; a Randomized Controlled Trial
This study aims to demonstrate the effect of combined exercise-education intervention in old adults with fall risk. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-education intervention with conventional medical care. Falls efficacy scale-international, fall history, Balance function, handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using DEXA and BIA, quality of life, depression, cognitive function, activities of daily living, nutritional assessment will be evaluated on baseline, 1-month, 3-months, 6-months, and 12-months after intervention.
Read the detailed description
A fall is defined as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level. And also, falls are the second leading cause of unintentional injury deaths worldwide. In particular, adults older than 65 years of age suffer the greatest number of fatal falls. It has been reported exercise in fall risk patients not only improved physical performance but also reduced the fall risk. Also, it is recently demonstrated that combined exercise-education (e.g., exercise training, medication review, nutrition counseling, home hazards modification) intervention reduced fall risk in elderly patients. However, there is still not established standard protocol for the combined exercise-education intervention. Therefore, the aim of this trial is to compare the effects of combined exercise-education intervention in fall risk patients with multicenter, multidisciplinary, randomized controlled trial.
- Conditions
- Falls Prevention
- Being tested
- Combined exercise-education intervention
- Keywords
- Falls, exercise, education, elderly
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exercise-education interventionOther
Combined exercise and education intervention by fall risk state for 12 months during intervention period.
Exercise intervention includes balance exercise and strength exercise according to protocol.
Education intervention includes medication review, nutrition intervention, and home hazard modification.
The key to medication review is paying special attention to medications known to increase the risk of falls. Reduction of these medications is recommended, and redundant psychotropic medications are withdrawn. Nutrition intervention includes investigating dietary habits and calculate insufficient protein intake to provide customized diet and high protein drink. If vitamin D necessary, supplements are prescribed. Home hazard modification includes providing instructions to reduce and modify the home hazards that increase the risk of falls.
| Study group | Role | What they receive |
|---|---|---|
| Combined exercise-education intervention group | Experimental | Combined exercise-education intervention by fall risk state for 12 months during intervention period. Receives: Other: Combined exercise-education intervention |
| Control group | No intervention | No intervention for 12 months during intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Korean Version of Falls Efficacy Scale-International (KFES-I)
Change from baseline falls efficacy to 1, 3, 6, 12 months after assessment, measured by Korean Version of Falls Efficacy Scale-International (KFES-I) [range from 16 to 64]. A higher value represents a high concern for falling.
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Secondary outcomes (13)
Falls history & injury
Evaluation of number of falls and type of falls in previous 12 months
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Physical performance
Short Physical Performance Battery [range from 0 to 12 score]
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Gait speed test
measured by 10 meter gait speed
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Balance function
Evaluation of physical balance function using Mini-Balance Evaluation System Test (Mini-BESTest) [range from 0 to 28]. Low value means poor ability of balance function.
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Handgrip strength
measured in kilograms (kg) using hand-held dynamometer
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Knee extensor muscle test
measured using a belt-stabilized hand-held dynamometer
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Physical activity volume
Evaluation of physical activity volume using Korean version of Physical Activity Scale for the Elderly (K-PASE) [range from 0 to 360 score]. Low value means poor physical activity
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Cognitive function
Evaluation of cognitive function using Korean-Montreal Cognitive Assessment (K-MoCA) [range from 0 to 30 score]. Low value means poor cognitive function
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Health related quality of life
Evaluation of quality of life using EuroQol-5 dimension (EQ-5D) [range from 5 to 25 score]. Higher value means worse quality of life
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Depression status
Evaluation of depression status using Patient Health Questionnaire-9 (PHQ-9) [range from 0 to 27 score]. Higher score indicates a higher severity of depressive symptoms
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Nutritional Assessment
Evaluation of nutritional state using Mini-Nutritional Assessment short form (MNA-SF) [range from 0 to 14 score]. Low value means poor nutrition status
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Appendicular skeletal muscle mass
measured using Bioelectrical Impedance Analysis (BIA)
Measured: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Bone density
measured using Dual-energy X-ray absorptiometry (DEXA)
Measured: Baseline (visit 1), 12 months after intervention (visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start24 Nov 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2026 (estimated)
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 Falls PreventionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Responsible party
- Principal investigator, Keewon Kim, Seoul National University Hospital
- Investigators
- Keewon Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615077
- Sponsor's protocol ID
- H-2208-176-1354
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palvanen M, Kannus P, Piirtola M, Niemi S, Parkkari J, Jarvinen M. Effectiveness of the Chaos Falls Clinic in preventing falls and injuries of home-dwelling older adults: a randomised controlled trial. Injury. 2014 Jan;45(1):265-71. doi: 10.1016/j.injury.2013.03.010. Epub 2013 Apr 8.
PubMed 23579066
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Comprehensive Intervention for the Prevention of Fall in Older Adults; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05615077
- Acronym / sponsor ID
- H-2208-176-1354
- Conditions
- Falls Prevention
- Keywords
- Falls, exercise, education, elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 14 Nov 2022 (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.
This study aims to demonstrate the effect of combined exercise-education intervention in old adults with fall risk. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-education intervention with conventional medical care. Falls efficacy scale-international, fall history, Balance function, handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using DEXA and BIA, quality of life, depression, cognitive function, activities of daily living, nutritional assessment will be evaluated on baseline, 1-month, 3-months, 6-months, and 12-months after intervention.
Detailed description
A fall is defined as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level. And also, falls are the second leading cause of unintentional injury deaths worldwide. In particular, adults older than 65 years of age suffer the greatest number of fatal falls. It has been reported exercise in fall risk patients not only improved physical performance but also reduced the fall risk. Also, it is recently demonstrated that combined exercise-education (e.g., exercise training, medication review, nutrition counseling, home hazards modification) intervention reduced fall risk in elderly patients. However, there is still not established standard protocol for the combined exercise-education intervention. Therefore, the aim of this trial is to compare the effects of combined exercise-education intervention in fall risk patients with multicenter, multidisciplinary, randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined exercise-education intervention group | Experimental | Other: Combined exercise-education interventionCombined exercise-education intervention by fall risk state for 12 months during intervention period. |
| Control group | No intervention | –No intervention for 12 months during intervention period. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- patients older than 65 years and under 90 years
- if at least one <3 key question> is met or <stay independent score> ≥ 4 points
- patients who can walk more than 10m without an assistive device (ambulatory without an assistive device)
- patients who are willing to participate in exercise intervention for 12 months
- patients who can receive information about this study, submit written consent before participating in the study, and can comply with the requirements of the clinical trial
Key exclusion criteria (7 listed)
- medically unstable conditions (e.g., cirrhosis with complications, end-stage renal failure requiring regular dialysis, hemorrhagic disease, uncontrolled hypertension, those who have been treated for a malignant tumor within 5 years)
- in case of ongoing neurological deficit except for stroke survivors (e.g., dementia, Alzheimer's disease, Parkinson's disease, etc.)
- decreased cardiopulmonary function such as heart failure, chronic obstructive pulmonary disease
- musculoskeletal problems that affect physical function and athletic ability (e.g., those who have undergone hip joint surgery, artificial joint surgery, spine surgery within the last 1 year)
- patients who have experienced alcohol abuse within the last 1 year (if 3 or more are meet in Cut off, Annoyed, Guilty, Eye opener [CAGE] evaluation)
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 |
|---|---|---|
| Combined exercise-education interventionCombined exercise and education intervention by fall risk state for 12 months during intervention period. Exercise intervention includes balance exercise and strength exercise according to protocol. Education intervention includes medication review, nutrition intervention, and home hazard modification. The key to medication review is paying special attention to medications known to increase the risk of falls. Reduction of these medications is recommended, and redundant psychotropic medications are withdrawn. Nutrition intervention includes investigating dietary habits and calculate insufficient protein intake to provide customized diet and high protein drink. If vitamin D necessary, supplements are prescribed. Home hazard modification includes providing instructions to reduce and modify the home hazards that increase the risk of falls. | Other | Combined exercise-education intervention group |
Primary outcome
Korean Version of Falls Efficacy Scale-International (KFES-I)
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Change from baseline falls efficacy to 1, 3, 6, 12 months after assessment, measured by Korean Version of Falls Efficacy Scale-International (KFES-I) [range from 16 to 64]. A higher value represents a high concern for falling.
13 secondary outcomes
Falls history & injury
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Physical performance
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Gait speed test
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Balance function
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Handgrip strength
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Knee extensor muscle test
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Physical activity volume
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Cognitive function
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Health related quality of life
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Depression status
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Nutritional Assessment
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Appendicular skeletal muscle mass
Time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)
Bone density
Time frame: Baseline (visit 1), 12 months after intervention (visit 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 23579066Palvanen M, Kannus P, Piirtola M, Niemi S, Parkkari J, Jarvinen M. Effectiveness of the Chaos Falls Clinic in preventing falls and injuries of home-dwelling older adults: a randomised controlled trial. Injury. 2014 Jan;45(1):265-71. doi: 10.1016/j.injury.2013.03.010. Epub 2013 Apr 8.
- 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.
Keewon Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise-education intervention in people with Falls Prevention, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 7 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 27 Jan 2023. 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 South Korea. 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 Keewon Kim, MD, PhD (+82-10-6238-9649, keewonkimm.d@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Korean Version of Falls Efficacy Scale-International (KFES-I) (time frame: Baseline (visit 1), 1 month after intervention (visit 2), 3 months after intervention (visit 3), 6 months after intervention (visit 4), 12 months after intervention (visit 5)). 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 NCT05615077, 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 27 Jan 2023.