NCT04078334

Brief Summary

Bed rest related to hospitalization contributes to the physical decline in capacities of the elderly, the loss of autonomy accelerated in post-hospitalization and the prevalence of the iatrogenic functional decline is about 20 to 50% for the elderly after an hospitalization. Mobilization through physical activity (PA) programs is strongly suggested to counter this phenomenon, but it is not part of the routine clinical hospital practices.The consequences are the functional incapacities, the mobility loss, the re-hospitalization falls and the important use of the health care and health services. In this regard, the Ministry of Health and Social Services adopted in 2011 a framework making mandatory the set up of interventions to prevent the functional decline of hospitalized elderly in every hospital centres in Quebec. The Geriatric Units (GU) admit elderly around 80 years old that present complex health problems. The scientific literature presents effective mobilisation programs to ensure the maintenance of functional capacities and the mobility of frail elderly. However, even with this knowledge, the prescription of physical exercises by the GU does not seem to be integrated in a natural and systematic way by in the professional practices. Our research team would like to implant the clinical tools : MATCH, PATH and PATH 2.0 that is a unique process of systematic prescriptions of physical activity during hospitalization (MATCH), at discharge (PATH) and during hospitalization and at discharge (PATH 2.0) in the GU, adapted to the profile of these patients. The objective of this project is to evaluate the implementation of the clinical tools MATCH, PATH and PATH 2.0 in different GU and to evaluate the tools efficiency and estimate the benefits-cost ratio on the use of post-hospitalization health services. Finally, the conclusions would help us refine the procedures to use in the short and medium term which clinical tool is likely a standard practice our GU and to improve the health continuum of elderly.

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
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

2.5 years

First QC Date

August 6, 2019

Last Update Submit

August 6, 2021

Conditions

Keywords

Frail older adultsPhysical activityexerciseHospitalization

Outcome Measures

Primary Outcomes (3)

  • Changes in short physical performance battery (SPPB) after intervention

    SPPB is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), 4-m habitual gait speed and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points.

    Up to 36 weeks

  • Changes in muscle strength after intervention (upper muscle strength : handgrip strength, lower limb strength: sit to stand-30sec)

    Handgrip strengh, sit to stand test (30sec)

    Up to 36 weeks

  • Changes in walking after intervention (Walking speed :4 m habitual gait speed and walking parameter : 3 meter timed up and go)

    4 m habitual gait speed test and 3 m timed up and go test

    Up to 36 weeks

Secondary Outcomes (10)

  • Feasibility of the clinical tools : MATCH, PATH, PATH 2.0

    Up to 24 months

  • Usability of the clinical tools : MATCH, PATH, PATH 2.0

    Up to 24 months

  • Acceptability of the clinical tools: MATCH, PATH, PATH 2.0

    Up to 24 months

  • Estimate the benefits-cost ratio on the use of post-hospitalization health services

    Up to 36 weeks

  • Changes in the length of stay after intervention

    up to 3 months

  • +5 more secondary outcomes

Study Arms (4)

Group 1

EXPERIMENTAL

PATH Tool : Prescription of exercise programs at discharge

Other: PATH

Group 2

EXPERIMENTAL

PATH 2.0 Tool : Prescription of exercise programs during hospitalization and discharge

Other: PATH 2.0

Group 3

EXPERIMENTAL

MATCH tool: Prescription of physical exercise programs during hospitalization

Other: MATCH

Group 4

NO INTERVENTION

Control group: Usual care by the clinical teams

Interventions

MATCHOTHER

In the first days of hospitalization, the physiotherapist determines the score linked to the patient's mobility profile using of a decisional tree. The PA program has 2 or 3 exercises to be done with or without supervision 3 times per week day during hospitalization. These daily exercises are prescribed by the doctor and taught by the physiotherapist.

Group 3
PATHOTHER

In the days prior to discharge, the physiotherapist determines the patient's mobility profile using the decisional tree. When returning home after hospitalization, each PA program includes a daily walk as well as 3 or 4 exercises that can be completed in a 12 to 20 minutes timeframe. These daily exercises are prescribed by the doctor and taught by the physiotherapist in 2 sessions.

Group 1

In the first days of hospitalization, the physiotherapist determines the score linked to the patient's mobility profile using of a decisional tree. The PA program has 2 or 3 exercises to be done with or without supervision 3 times per week day during hospitalization. These daily exercises are prescribed by the doctor and taught by the physiotherapist. In the days prior to discharge, the physiotherapist determines the patient's mobility profile using the decisional tree. When returning home after hospitalization, each PA program includes a daily walk as well as 3 or 4 exercises that can completed in a 12 to 20 minutes timeframe. These daily exercises are prescribed by the doctor and taught by the physiotherapist in 2 sessions.

Group 2

Eligibility Criteria

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Units

Montreal, Quebec, Canada

RECRUITING

Related Publications (1)

  • Peyrusque E, Kergoat MJ, Filali-Mouhim A, Veillette N, Fonseca R, Sirois MJ, Aubertin-Leheudre M. Effect of a Pragmatic Exercise Intervention Pilot Study on Preventing Functional and Physical Decline in Hospitalized Older Adults. Med Sci Sports Exerc. 2025 Jul 1;57(7):1570-1578. doi: 10.1249/MSS.0000000000003687. Epub 2025 Mar 3.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Mylene Aubertin-Leheudre, Ph. D

    Université du Québec a Montréal

    PRINCIPAL INVESTIGATOR
  • Marie-Jeanne Kergoat, M.D., FRCPC

    Centre de recherche de l'institut Universitaire de Gériatrie de Montreal

    PRINCIPAL INVESTIGATOR
  • Fonseca Raquel, Ph. D

    Université du Québec a Montréal

    PRINCIPAL INVESTIGATOR
  • Veillette Nathalie, Ph.D

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mylene Aubertin-Leheudre, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principale Investigator-Researcher

Study Record Dates

First Submitted

August 6, 2019

First Posted

September 6, 2019

Study Start

October 2, 2020

Primary Completion

April 1, 2023

Study Completion

October 1, 2025

Last Updated

August 13, 2021

Record last verified: 2021-08

Locations