Effectiveness of Comprehensive Intervention for the Prevention of Fall in Older Adults; a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 484
- Locations
- 1
- Primary Endpoint
- Korean Version of Falls Efficacy Scale-International (KFES-I)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 65 Years to 95 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •* patients older than 65 years and under 90 years
- •* if at least one \<3 key question\> is met or \ ≥ 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
Arms & Interventions
Combined exercise-education intervention group
Combined exercise-education intervention by fall risk state for 12 months during intervention period.
Intervention: Combined exercise-education intervention (Other)
Control group
No intervention for 12 months during intervention period.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Gait speed test(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))
- Falls history & injury(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(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(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(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(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(Baseline (visit 1), 12 months after intervention (visit 5))
- Physical performance(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(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(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(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(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(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))
Investigators
Keewon Kim
Clinical Associate Professor
Seoul National University Hospital