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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03991598
Other study ID # MP-20-2017-3235
Secondary ID 364485
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date July 2020

Study information

Verified date June 2019
Source CHU de Quebec-Universite Laval
Contact Marie-Josée MJ Sirois, Ph.D
Phone 418-649-0252
Email marie-josee.sirois@rea.ulaval.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise program
Exercise program in communities / Exercise program at home

Locations

Country Name City State
Canada Alberta Health Services Calgary Alberta
Canada Alberta Health Services Edmonton Alberta
Canada Hôpital Sacré-Coeur Montréal Quebec
Canada Ottawa Hospital Research Institute Ottawa Ontaro
Canada CHU-Québec Quebec City Quebec
Canada Sunnybrook Health Science Center Toronto Ontario

Sponsors (16)

Lead Sponsor Collaborator
CHU de Quebec-Universite Laval Alberta Health Services, Calgary, Canadian Institutes of Health Research (CIHR), Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Hopital du Sacre-Coeur de Montreal, Laval University, McMaster University, Mount Sinai Hospital, Canada, Ottawa Hospital Research Institute, Sunnybrook Research Institute, The Ottawa Hospital, Université de Montréal, Universite du Quebec a Montreal, University of Ottawa, University of Toronto, Washington University School of Medicine

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes in mean SPPB scores at 3 and 6 months after the initial ED visit (baseline) The SPPB (Short Physical Portable Battery) combines walking, balance and strength items. Scores range from 0 to 12 (best). 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 Changes in mean SOF Frailty index scores at 3 and 6 months after the initial ED visit (from Baseline) The SOF index is a Frailty measure. Scores range from 0/3 (robust senior) to 3/3 (frail senior) 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
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