NCT02393014

Brief Summary

This study aims to evaluate the feasibility and the impact on physical performance and falls occurence among geriatric inpatients hospitalized in acute care unit.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ 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

First Submitted

Initial submission to the registry

February 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

September 22, 2016

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

February 5, 2015

Last Update Submit

September 21, 2016

Conditions

Elderly

Keywords

65 years old or olderhospitalized ingeriatrics

Outcome Measures

Primary Outcomes (1)

  • Number of participants in each category of fall risk having realized 75% and more of the exercises of at least one of the three difficulty levels of the physical activity program

    The feasibility of the interventions of each fall risk category is defined as "at least 80% of the participants of a category having completed 75% and more of the exercises".

    up to 15 months

Secondary Outcomes (4)

  • Change of number of patients having realized the Five Time Sit and Stand (FTSS) test.

    up to 15 months

  • For the patients having achieved FTSS test, the realization time (in seconds).

    up to 60 seconds

  • Measure (by the medical team) of the difficulty to set up and carry out the exercises

    up to 20 days

  • Time needed by the paramedical team to achieve the exercises

    up to 20 days

Study Arms (3)

Low fall risk

EXPERIMENTAL

low fall risk patients

Procedure: Simple physical exercises

Medium fall risk

EXPERIMENTAL

medium fall risk patients

Procedure: Simple physical exercises

High fall risk

EXPERIMENTAL

high fall risk patients

Procedure: Simple physical exercises

Interventions

Simple physical exercisesPROCEDURE

1. The participant must stay out of the bed 3 hours. This pre-required level prevents the occurrence of acute postural mismatch which can occur when elderly patients are bedridden and too long increases the risk of falling. 2. The participant stands standing in static equilibrium to a chair holding the back of it for 2 minutes. Depending on the patient's abilities, the exercise will be done on both feet or one foot. 3. The participant performs a transfer activity of sitting to standing repeated 5 times (FTSS test). According to the patient's abilities, the exercise will be done with physical assistance or not.

High fall riskLow fall riskMedium fall risk

Eligibility Criteria

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

You may qualify if:

  • Being 65 years old and older
  • Being hospitalized in geriatric acute care unit of Angers University Hospital.
  • No contraindications to physical activity practice.
  • No contraindications to standing station and sitting station.
  • Participants having given and signed an informed participation consent. If the participant is unable to answer, we will retain the disagreement expressed by a trusted person.
  • Being affiliated to French social security

You may not qualify if:

  • Refusal of participation
  • Persons aged under 65.
  • Topics including hospitalization at the entrance should not exceed 3 days.
  • Participation in concomitant clinical trial.
  • Civil Protection Measures such as trusteeship, guardianship or backup justice underway.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, Maine et Loire, 49933, France

Location

Related Publications (1)

  • Noublanche F, Simon R, Ben-Sadoun G, Annweiler C. Physical Activity and Fall Prevention in Geriatric Inpatients in an Acute Care Unit (AGIR Study): Protocol for a Usability Study. JMIR Res Protoc. 2022 Jul 11;11(7):e32288. doi: 10.2196/32288.

    PMID: 35816381DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

March 19, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Last Updated

September 22, 2016

Record last verified: 2015-02

Locations

FR(1)