NCT05615077

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 484 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Falls Prevention

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-24
• Primary completion: 2025-05-31
• Completion: 2026-05-31
• First posted: 2022-11-14
• Last updated: 2023-01-27

Locations

1 site across 1 country: South Korea