NCT07492745

Brief Summary

Around 30% of patients aged 65 and over experience functional decline due to hospitalization. Physical inactivity, often without medical justification, is common during hospital stays.This immobility leads to loss of autonomy, muscle strength, and increases post-discharge risks. Slow walking for 25-40 minutes daily significantly improves functional capacity. However, it could be difficult to reach this time of walking due to a lack of physiotherapist in hospital. A vibrating watch may encourage patients to walk or perform strengthening exercises. This simple intervention aims to improve function without requiring additional staff or resources

Trial Health

80
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Nov 2025Jan 2029

Study Start

First participant enrolled

November 19, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

January 19, 2026

Last Update Submit

April 21, 2026

Conditions

InpatientsFrail

Keywords

inpatientsphysical activityreminder devicefrailtyfunctional independancy

Outcome Measures

Primary Outcomes (1)

  • SPPB

    The SPPB (Short Physical Performance Battery) is the sum of scores on three criteria: the balance test, the walking speed test, and the chair rise test. This test assesses an individual's physical performance. The score ranges from 0 (lowest) to 12 (highest). The magnitude of change considered clinically relevant for the SPPB is 1 point.

    Within 24 hours of admission and within 48 hours prior to discharge from hospital.

Secondary Outcomes (7)

  • Volume and intensity of physical activity

    Within 24 hours of admission and within 48 hours prior to discharge from hospital.

  • functional independancy

    Within 24 hours of admission and within 48 hours prior to discharge from hospital.

  • Patient compliance to the prescribed exercises

    Within 24 hours of baseline and within 48 hours prior to discharge from hospital

  • falls

    Within 24 hours of baseline and within 48 hours prior to discharge from hospital ; and at 3 months after discharge.

  • Volume and type of rehabilitation in-hospital

    Within 24 hours of baseline and within 48 hours prior to discharge from hospital

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Regardless of randomization, the physiotherapist will be able to provide the patient with the usual care, such as walking, muscle strengthening exercises, and respiratory physiotherapy if necessary. Self-rehabilitation exercises will be given to the patient, who will have to perform them independently. The exercises will be prescribed according to the patient's physical abilities and environmental constraints. A vibrating reminder will be given to the patient, set to go off six times a day. The patient will be required to perform the prescribed exercises each time the vibrating alarm goes off. Six vibrating reminders per day will be sent in the hope that the patient will be active at least three times a day, taking into account various constraints (visits, medical care, examinations, fatigue).

Device: Vibrating reminder

control

SHAM COMPARATOR

In the control group, the physiotherapist will perform the usual treatments and apply the protocol described above in the experimental group, but will set the vibrating watch, to go off once a day. The patient will be advised to perform the exercises every hour independantly.

Device: Control group

Interventions

Vibrating reminderDEVICE

The exercises will be prescribed according to the patient's physical abilities and environmental constraints. A vibrating reminder will be given to the patient, set to go off six times a day.

Intervention
Control groupDEVICE

The exercises will be prescribed according to the patient's physical abilities and environmental constraints. A vibrating reminder will be given to the patient, set to go off once time a day.

Also known as: usual care
control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 50 or over with a score of 4 or above on the Clinical Frailty Scale (vulnerable but not dependent patients, symptoms limiting activities, patients who are slower/more fatigued).
  • Must be able to get up from a chair without assistance.
  • Patients must be able to communicate with staff, understand instructions, give consent, and cooperate with staff.

You may not qualify if:

  • Patients with an estimated hospital stay of less than 5 days.
  • Contraindications to physical activity determined by the medical team (e.g., cardiovascular instability, orthopedic contraindications, etc.).
  • Terminal illness.
  • Patients scheduled for surgery.
  • Pregnant women.
  • People who do not understand French.
  • People protected under the law.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Erasme Route de Lennick 808

Brussels, 1070, Belgium

NOT YET RECRUITING

Groupe Hospitalier du Havre

Le Havre, Normandy, 76290, France

RECRUITING

Centre hospitalier de Chartres

Le Coudray, 28630, France

NOT YET RECRUITING

centre hospitalier de Valence

Valence, 26000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Motor ActivityFrailty

Interventions

Control Groups

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Léa Bansard, PT, MSc

    Groupe Hospitalier du Havre

    PRINCIPAL INVESTIGATOR

  • Guillaume Prieur, PT, PhD

    Groupe Hospitalier du Havre

    PRINCIPAL INVESTIGATOR

  • Yann Combret, PT, PhD

    Groupe Hospitalier du Havre

    STUDY DIRECTOR

  • Clément Medrinal, Prof.

    Groupe Hospitalier du Havre

    STUDY CHAIR

Central Study Contacts

Guillaume Prieur, PT, PhD

CONTACT

+33630038824guillaume.prieur@ch-havre.fr

Yann Combret, PT, PhD

CONTACT

+33686327255yann.combret@ch-havre.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2026

First Posted

March 25, 2026

Study Start

November 19, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

April 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Data type : deidentified participant data

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Start date : after publication End date : 15 years after publication
Access Criteria
the request shall be sent to Guillaume Prieur : guillaume.prieur@ch-havre.fr

Locations

FR(3)BE(1)