RecruitingNot ApplicableNCT05615077

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


Sponsor

Seoul National University Hospital

Enrollment

484 participants

Start Date

Nov 24, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 65 YearsMax Age: 95 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERCombined 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.


Locations(1)

Seoul National University Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05615077


Related Trials