NCT03981471

Brief Summary

In communities with over 100,000 residents, to investigate the incidence and mechanisms of fall in elderly, and strategies of fall prevention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress92%
Jun 2019Dec 2026

Study Start

First participant enrolled

June 3, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

7.6 years

First QC Date

June 5, 2019

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of fall

    Incidence of fall each year

    From date of recruitment until the end of the study, assessed up to 42 months (reported once per year)

Secondary Outcomes (5)

  • Kinematics test

    From date of recruitment until the end of the study, assessed up to 42 months

  • Kinetics test

    From date of recruitment until the end of the study, assessed up to 42 months

  • EEG test

    From date of recruitment until the end of the study, assessed up to 42 months

  • fNIRS test

    From date of recruitment until the end of the study, assessed up to 42 months

  • MRI assessments

    From date of recruitment until the end of the study, assessed up to 42 months

Study Arms (2)

Elderly without fall history

OTHER

Elderly people in the community who have no fall history

Behavioral: Exercise

Elderly with fall history

OTHER

Elderly people in the community who have fall history

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Elderly people with or without fall history receive exercise to improve balance. Exercise interevention will be given 6 months in 2020. Outcomes (incidence of fall and biological tests) between two arms will be compared.

Elderly with fall historyElderly without fall history

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • community dwelling adults without medical conditions to impair walking ability

You may not qualify if:

  • cognitively or physically unable to cooperate with the examiner to finish the test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Research Center for Rehabilitation Technical Aids

Beijing, Beijing Municipality, 100176, China

NOT YET RECRUITING

National Research Center for Rehabilitation Technical Aids

Beijing, 100176, China

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 10, 2019

Study Start

June 3, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations