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

Elderly Clinical Trial

— AGIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393014
• Other study ID #: 2014-30
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: September 21, 2016
• Start date: April 2015

Study information

• Verified date: February 2015
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Elderly

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital	Angers	Maine et Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change of number of patients having realized the Five Time Sit and Stand (FTSS) test.		up to 15 months	No
Secondary	For the patients having achieved FTSS test, the realization time (in seconds).		up to 60 seconds	No
Secondary	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	No
Secondary	Time needed by the paramedical team to achieve the exercises		up to 20 days	No