NCT06089213

Brief Summary

Fall incidents are the third cause of chronic disability in the elderly, according to the World Health Organization (WHO). Recent reviews demonstrate that multifactorial and multicomponent intervention programs are effective in preventing falls in community-dwelling older adults. However, the application of these programs may not be accessible to a large part of the elderly population. The lack of continuity in the treatment of the consequences of falls, as well as the dissemination of prevention measures for this patient profile, could be minimized through the use of information and communication technologies. Method: This will be a randomized clinical trial that aims to evaluate the effects of two fall prevention strategies via telerehabilitation for elderly fallers after admission to an emergency room. It will be carried out by a multidisciplinary team with interventions for eight weeks and monitoring of outcomes over a period of four months. Patients will be evaluated regarding aspects of functionality in the second and month after the interventions and regarding the recurrence of falls during the four-month period. Discussion: The hypothesis is that the programs are viable in terms of accessibility to home training. However, to date, there is no evidence about the differences between these forms of interventions to prevent falls via telecare.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2.7 years

First QC Date

September 26, 2023

Last Update Submit

October 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of Falls

    After the intervention periods, participants will be followed for another 16 weeks. Every week, recurrences of falls will be recorded via telephone calls. You will be asked whether there were falls in the period

    four months

Secondary Outcomes (5)

  • Concern of falls

    through study completion, an average of 1 year

  • Balance

    through study completion, an average of 1 year

  • Arms Muscle strength

    through study completion, an average of 1 year

  • Legs Muscle strength

    through study completion, an average of 1 year

  • Functionality

    through study completion, an average of 1 year

Study Arms (2)

Interactive services

EXPERIMENTAL

Otago exercises performed in "real-time" or "synchronous" mode of digital health care. It consists of direct communication between physiotherapist and the patient.

Other: real-time intervention

Remote telemonitoring

ACTIVE COMPARATOR

Otago exercises performed remotely, using technologies such as messaging apps. It consists of indirect communication between physiotherapist and the patient.

Other: real-time intervention

Interventions

An individual exercise program will be carried out at home, supervised remotely via videoconference.

Interactive servicesRemote telemonitoring

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elderly fallers

You may not qualify if:

  • neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Pronto Socorro

Porto Alegre, Rio Grande do Sul, 90880-370, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 18, 2023

Study Start

January 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 2, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations