NCT03991598

Brief Summary

About 18% of independent people over 65 who are evaluated in Emergency Departments for minor injuries (fractures, sprains) present some mobility decline up to 3 to 6 months postinjury. People at risk of decline are prefrail or frail; this condition could be explained by muscle proprieties loss. Exercise is a proven method that can help limit frailty and allow to restore mobility. The aim of our study is to evaluate whether a suitable exercise program of one hour, twice a week for 12 weeks will limit functional losses \& fragility in injured older adults after their emergency department visit.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

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 Start

First participant enrolled

July 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

2.9 years

First QC Date

July 19, 2017

Last Update Submit

June 18, 2019

Conditions

ElderlyFunctional Status

Keywords

FrailPrefrailMobile decline

Outcome Measures

Primary Outcomes (1)

  • Changes in Cumulative Incidence of Functional Decline at 3 and 6 months after the intial ED visit (Baseline)

    Proportions of participants showing, at 3 or 6 months post-ED visit, a loss ≥2/28 on the OARS scale, compared to Baseline. (OARS: Older American Resource and Services multidimensional functional scale, which includes 7 basic ADLs and 7 instrumental ADLs items)

    Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation

Secondary Outcomes (2)

  • Changes in mean SPPB scores at 3 and 6 months after the initial ED visit (baseline)

    Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation

  • Changes in mean SOF Frailty index scores at 3 and 6 months after the initial ED visit (from Baseline)

    Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation

Study Arms (2)

intervention

EXPERIMENTAL

EDs 1 to 7 will then be randomly phased-in INT every 3 months.

Other: Exercise program

control

NO INTERVENTION

During the first 6 months and throughout CTRL time

Interventions

Exercise programOTHER

Exercise program in communities / Exercise program at home

intervention

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Consultation at Emergency Department (ED) for an injury
  • Injury happened in the 14 days prior to ED visit
  • years old and over
  • Discharge from ED within 48 hours
  • Independant in basic Activities of Daily Living (ADL)

You may not qualify if:

  • Hospitalization related to the trauma
  • Major surgery related to the trauma
  • Not independant in ADL
  • Living in a long-term care home
  • Important cognitive impairment
  • Not speaking French or English
  • Unable to consent
  • No trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Alberta Health Services

Calgary, Alberta, T2N 2T9, Canada

NOT YET RECRUITING

Alberta Health Services

Edmonton, Alberta, TG2 2C8, Canada

NOT YET RECRUITING

Sunnybrook Health Science Center

Toronto, Ontario, M4N 3M5, Canada

ACTIVE NOT RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontaro, K1Y 4E9, Canada

NOT YET RECRUITING

Hôpital Sacré-Coeur

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

CHU-Québec

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

Related Publications (2)

  • Sirois MJ, Blais J, Aubertin-Leheudre M, Carmichael PH, Fruteau de Laclos L, Desjardins A, Daoust R, Eagles D, Lee J, Perry JJ, Salbach NM, Emond M. Effectiveness of Exercise in Older Adults Discharged From the ER After Minor Injuries: The CEDeComS Stepped-Wedge Trial. J Am Geriatr Soc. 2026 Jan;74(1):74-84. doi: 10.1111/jgs.70166. Epub 2025 Oct 20.

    PMID: 41116303DERIVED

  • Sirois MJ, Carmichael PH, Daoust R, Eagles D, Griffith L, Lang E, Lee J, Perry JJ, Veillette N, Emond M; Canadian Emergency Team Initiative on Mobility in Aging. Functional Decline After Nonhospitalized Injuries in Older Patients: Results From the Canadian Emergency Team Initiative Cohort in Elders. Ann Emerg Med. 2022 Aug;80(2):154-164. doi: 10.1016/j.annemergmed.2022.01.041. Epub 2022 Mar 16.

    PMID: 35305850DERIVED

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marcel ME Emond, Md, Ph.D

    Centre de recherche du CHU de Québec

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Josée MJ Sirois, Ph.D

CONTACT

418-649-0252marie-josee.sirois@rea.ulaval.ca

Sandrine SH Hegg, Ph.D

CONTACT

418-649-0252ceti.mobility@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a step-wedge clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D Independent Researcher - Mid Career Investigator

Study Record Dates

First Submitted

July 19, 2017

First Posted

June 19, 2019

Study Start

July 1, 2017

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

June 19, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Locations

CA(6)