Physical Activity and Fall Prevention in Geriatric Inpatients in Acute caRe: Feasibility Study (AGIR)

Activité Physique et prévention de la Chute du Patient âGé hospItalisé en Court séjouR: Etude de faisabilité (AGIR)

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

Study Overview

• Status: Completed
• Conditions: Elderly
• Intervention / Treatment: Procedure: Simple physical exercises

Detailed Description

Having developed many tools to determine fall risk of 65 years and older patients, Angers University Hospital plans to develop a corrective action to prevent the occurrence of falls in this population.

This study aims to assess the feasibility of a physical activity program with 3 difficulty levels (depending on the patient's risk of falling): easy (low fall risk), moderate (average fall risk) and difficult (high fall risk).

The implementation process should be simply and fastly applicable in practice for routine care by paramedics.

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Maine et Loire
    • Angers, Maine et Loire, France, 49933
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low fall risk; low fall risk patients	Procedure: Simple physical exercises; 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.; 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.; 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.
Experimental: Medium fall risk; medium fall risk patients	Procedure: Simple physical exercises; 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.; 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.; 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.
Experimental: High fall risk; high fall risk patients	Procedure: Simple physical exercises; 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This measure will be assessed with a scale : "very easy" ; "easy" ; "feasible" ; "difficult" ; "impossible"	up to 20 days
Time needed by the paramedical team to achieve the exercises		up to 20 days

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: geriatrics; 65 years old or older; hospitalized in
• Other Study ID Numbers: 2014-30