Clinical trial NCT05615077: Multidisciplinary Combined Exercise and Education Intervention for Falls in Older Adults
Official title: Effectiveness of Comprehensive Intervention for the Prevention of Fall in Older Adults; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Falls Prevention
Keywords: Falls, exercise, education, elderly
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Evidence-Based Healthcare Collaborating Agency
First posted: 2022-11-14
Enrollment: 484
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Korean Version of Falls Efficacy Scale-International (KFES-I)
timeFrame: 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:
measure: Falls history & injury
timeFrame: 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)
measure: Physical performance
timeFrame: 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)
measure: Gait speed test
timeFrame: 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)
measure: Balance function
timeFrame: 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)
measure: Handgrip strength
timeFrame: 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)
measure: Knee extensor muscle test
timeFrame: 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)
measure: Physical activity volume
timeFrame: 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)
measure: Cognitive function
timeFrame: 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)
measure: Health related quality of life
timeFrame: 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)
measure: Depression status
timeFrame: 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)
measure: Nutritional Assessment
timeFrame: 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)
measure: Appendicular skeletal muscle mass
timeFrame: 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)
measure: Bone density
timeFrame: Baseline (visit 1), 12 months after intervention (visit 5)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Keewon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.