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Status unknownNCT04327115ACTI-PACTUpdated Jun 11, 2024

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

An interventional study of "Control" strategy and "Intervention" strategy in Physical Activity and Aged, sponsored by University Hospital, Angers. Status unknown at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
864
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study 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
Read the detailed description

The aging of the French population leads to a significant increase in elderly hospitalizations. These patients are often dependent, polymorbid and precarious from a medical, social and economic point of view, bringing them into a frailty process to which the health system is trying to adapt. In fact, the absence of specific care adapted to frail elderly patients results in an increased risk of functional maladjustment. It is characterized by a loss, during hospitalization, of the ability to perform the activities of daily living alone and a decrease in physical activity. This maladjustment can differ or even prevent return home, increases the risk of falling, the length of stay and health expenses.

The concept of frailty in the elderly is mainly based on the concept of physical vulnerability, and in particular muscular vulnerability. Increasing attention is therefore being paid to physical activity in the elderly, which can prevent the process of maladjustment.

The 2004802 Decree of July 29, 2004 recalls that nurses lift patients and help them to walk without using rehabilitation techniques, to ensure their comfort. The interest of such an approach has already been reported, especially in primary care where nursing support allows a sustained and lasting increase in physical activity in the elderly. To the best of the investigators' knowledge, the effectiveness of such a nursing approach to physical activity support has not been studied in hospitals yet.

The investigators looked for exercises simple, fast and adapted to an elderly population with a very diverse functional maladjustment. The selected intervention is a physical activity based on the activities of daily living to improve postural balance and strengthening the muscles of the lower limbs. This intervention follows the main principles of the latest recommendations of the French High Authority for Health on the elderly fall prevention. It resumes acts such as sitting or standing on a foot corresponding to static equilibrium conditions. It also proposes carrying out transfers from a sitting to standing position and from a standing to sitting position corresponding to motor acts for the lower limbs.

The investigators hypothesize that formalized paramedical support in a geriatric short-stay service prevents the elderly from decreasing their physical activity, and prevents the occurrence of falls and early re-hospitalization.

02

Conditions studied

  • Physical Activity
  • Aged

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03

In context

Motor Activity

2,646 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.

This study's planned enrollment of 864 is above the median of 60 across 2,309 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 477 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
864 participants (estimated)

Study arms

  • Other
    Arm 1

    (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

  • Other
    Arm 2

    (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

  • Other
    Arm 3

    (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

  • Procedure"Control" strategy

    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.

  • Procedure"Intervention" strategy

    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)

06

What researchers measure

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).

    Time frame: this outcome is assessed at Day 5 after inclusion.

Secondary outcomes

  1. Change in the daily physical expenditure in metabolic equivalent

    The daily physical expenditure is evaluated by the actimeter in MET (Metabolic Equivalent of Task)

    Time frame: This outcome is assessed between Day 1 and Day 5.

  2. Change in the daily number of steps

    The daily number of steps is evaluated by the actimeter

    Time frame: This outcome is assessed between Day 1 and Day 5.

  3. Change in the daily physical expenditure

    The daily physical expenditure is evaluated by the actimeter

    Time frame: This outcome is assessed between Day 1 and Day 5.

  4. Change in care course

    The care course is evaluated by the length of hospitalization

    Time frame: This outcome is assessed between Day 0 and Day 60.

  5. Change in care course

    The care course is assessed by the occurrence of a new hospitalization

    Time frame: This outcome is assessed between Day 6 and Day 30.

  6. Change in falls occurrence

    The falls occurrence is assessed by the number of falls reported by the participant

    Time frame: This outcomes is assessed between Day 0 and Day 6, then while the 60 days after inclusion.

  7. Change in patient autonomy

    Autonomy is assessed with Activities of Daily Living (ADL) score. ADL is an autonomy assessment grid (from 0 to 6) for basic activities of daily living (ADL). The lower the score, the more dependent the patient is.

    Time frame: This outcomes is assessed at baseline and 60 days after inclusion.

  8. Change in moving habits

    Moving habits are assessed with the Life-Space Assessment questionnaire. 120 is the highest score (the best mobility) 0 is the worst score (the worst mobility)

    Time frame: This outcomes is assessed at baseline and 60 days after inclusion.

07

Study locations

1 of 1 sites recruiting
  • Cédric ANNWEILER , MD, PhD
    Angers, 49933, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04327115
Responsible party
Sponsor
First posted
Mar 30, 2020
Start date
Oct 21, 2021
Primary completion
Oct 20, 2025 (estimated)
Completion
Dec 20, 2025 (estimated)
Last update
Jun 11, 2024

Study contacts

Cédric ANNWEILER, MD, PhD
Contact
cedric.annweiler@chu-angers.fr
+33 2 41 35 54 86 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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