NCT05615077

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Nov 2022May 2026

First Submitted

Initial submission to the registry

November 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

November 24, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

2.5 years

First QC Date

November 3, 2022

Last Update Submit

January 25, 2023

Conditions

Falls Prevention

Keywords

Falls, exercise, education, elderly

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • 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)

  • 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)

  • 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)

  • 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

    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)

  • +8 more secondary outcomes

Study Arms (2)

Combined exercise-education intervention group

EXPERIMENTAL

Combined exercise-education intervention by fall risk state for 12 months during intervention period.

Other: Combined exercise-education intervention

Control group

NO INTERVENTION

No intervention for 12 months during intervention period.

Interventions

Combined exercise-education interventionOTHER

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.

Combined exercise-education intervention group

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23579066BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Keewon Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keewon Kim, MD, PhD

CONTACT

+82-10-6238-9649keewonkimm.d@gmail.com

Seongdae Kim, PhD

CONTACT

+82-10-3059-3217kimsd@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 14, 2022

Study Start

November 24, 2022

Primary Completion

May 31, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)