Multidisciplinary Combined Exercise and Education Intervention for Falls in Older Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Falls Prevention
• Intervention / Treatment: Other: Combined exercise-education 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 Type: Interventional
• Enrollment (Anticipated): 484
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keewon Kim, MD, PhD; Phone Number: +82-10-6238-9649; Email: keewonkimm.d@gmail.com
• Study Contact Backup: Name: Seongdae Kim, PhD; Phone Number: +82-10-3059-3217; Email: kimsd@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Keewon Kim, MD, PhD
    • Principal Investigator: Keewon Kim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined exercise-education intervention group; Combined exercise-education intervention by fall risk state for 12 months during intervention period.	Other: Combined exercise-education intervention; 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.
No Intervention: Control group; No intervention for 12 months during intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls history & injury	Evaluation of number of falls and type of falls in previous 12 months	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]	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	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.	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	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	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	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	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	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	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	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)	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)	Baseline (visit 1), 12 months after intervention (visit 5)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: National Evidence-Based Healthcare Collaborating Agency
• Investigators: Principal Investigator: Keewon Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Anticipated): May 31, 2025
• Study Completion (Anticipated): May 31, 2026

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Falls, exercise, education, elderly
• Other Study ID Numbers: H-2208-176-1354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No