Study of an Physical Exercise Program on Older People of 75 Years Old and More, Hospitalized in Geriatric Short Stay

NCT04327115 | Recruiting

• 1 other identifier: 2019-A01800-57
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to assess the effect, compared to usual care, of a nursing accompaniment or nursing assistant intervention in the physical activity of patients hospitalized in the geriatric stay, on the daily number of steps. The secondary objectives consist in evaluating the effect, compared to usual care, of a nursing or nursing assistant's intervention in physical activity of elderly patients hospitalized on a short geriatric stay in terms of:

• The change of the daily physical exertion in metabolic equivalent
• The change of the daily number of steps
• The change of care course
• The change of in falls occurrence
• The change of autonomy patient
• The change of travels habits

Conditions

Physical Activity; Aged

Outcome Measures

Primary Outcomes (1)

• Change in the number of steps

  the relative evolution of the number of steps between the 1st day (D1) and the 5th day (D5) is calculated with this formula : Δ nbsteps (%) = (D5 number of steps - D1 number of steps)\*100 / ((D1 number of steps + D5 number of steps)/2).

  this outcome is assessed at Day 5 after inclusion.

Secondary Outcomes (8)

• Change in the daily physical expenditure in metabolic equivalent

  This outcome is assessed between Day 1 and Day 5.

• Change in the daily number of steps

  This outcome is assessed between Day 1 and Day 5.

• Change in the daily physical expenditure

  This outcome is assessed between Day 1 and Day 5.

• Change in care course

  This outcome is assessed between Day 0 and Day 60.

• Change in care course

  This outcome is assessed between Day 6 and Day 30.

Study Arms (3)

Arm 1

OTHER

(C-I-I-I) : the centers apply the "Control" strategy in Period 1 and then apply the "Intervention" strategy in Periods 2 to 4.

Procedure: "Control" strategy; Procedure: "Intervention" strategy

Arm 2

OTHER

(C-C-I-I) : the centers apply the "Control" strategy in periods 1 and 2 and then apply the "Intervention" strategy in periods 3 and 4.

Procedure: "Control" strategy; Procedure: "Intervention" strategy

Arm 3

OTHER

(C-C-C-I) : the centers apply the "Control" strategy in periods 1, 2 and 3 and then apply the "Intervention" strategy for period 4.

Procedure: "Control" strategy; Procedure: "Intervention" strategy

Interventions

"Control" strategy PROCEDURE

Patients included in the "control" group will received the usual cares of the unit during their stay : support in the gestures of daily life and walking according to their ability and at the discretion of the care teams.

Arm 1; Arm 2; Arm 3

"Intervention" strategy PROCEDURE

Patients included in the "intervention" group will received the usual cares of the unit during their stay : support in the gestures of daily life and walking according to their ability and at the discretion of the care teams. They will also get a physical activity program realized with a nurse or a nursing assistant, twice a day (morning and evening) for 5 days. The intervention consists of physical support with mimed instructions, the nature of which depends on the falling risk of the participant : * High falling risk : "out of bed" exercise (on a chair for at least 30 min) * Mild falling risk : "out of bed" exercise + "in front of chair" (The participant stands standing in static equilibrium to a chair holding the back of it for 2 minutes, on both feet or one foot) * Low falling risk : "out of bed" exercise + "in front of chair" + FTSS exercise (The participant performs a transfer activity of sitting to standing repeated 5 times, with physical assistance or not)

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Men or women ≥ 75 years old
• Hospitalization in geriatric short stay
• Informed and express (oral) consent to participate in the study by the patient or the patient's representative
• Affiliation to French Social Security.

You may not qualify if:

• Neurological or orthopedic pathology that prevents the performance of one or more exercises corresponding to the patient's level of risk of falling
• Short expected hospital stay
• Contraindication to physical activity
• Person subject to a safeguard of justice measure
• Patient who previously participated to the study.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Cédric ANNWEILER , MD, PhD

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Cédric ANNWEILER, MD, PhD

CONTACT

+33 2 41 35 54 86; cedric.annweiler@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: stepped wedge cluster randomised trial

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 30, 2020
• Study Start: October 21, 2021
• Primary Completion: October 20, 2025
• Study Completion: December 20, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

FR (1)