- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07492745
Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay. (REMOTIVE)
Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay : a Multicenter Randomised Controlled Double Blind Study.
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
30% of patients aged 65 or older will experience a decline in functional capacity as a result of hospitalization.
Illness and hospitalization increase sedentary behavior in patients. It is common for patients to spend long periods of time resting in bed, regardless of their primary reason for admission. During hospitalization, nearly 60% of episodes of bed rest have no documented medical indications. Low physical activity during hospitalization can lead to impaired independence, loss of muscle strength, and decreased functional capacity. These losses in frail individuals are associated with increased disability and lead to a critical 30-day period after hospital discharge that exacerbates deconditioning. This period of increasing functional vulnerability can lead to readmission to hospital, disability, institutionalization, morbidity, and early mortality.
The results of a meta-analysis show that walking slowly for about 25-40 minutes per day is sufficient to improve patients' functional capacity during hospitalization. The organization of care to promote patient mobility must be reviewed to make patients more involved in their care and more independent.
It has been demonstrated for some time that the use of a reminder system (e.g., alarm) is a factor that promotes increased patient adherence to their treatments. The advantage of a vibrating reminder is that it is simple to use, very inexpensive, easy to implement in all hospital wards, and does not require additional human resources.
The main hypothesis of this study is that the use of a vibrating watch set to 6 reminders per day to prompt patients to perform muscle strengthening exercises or walk a distance determined by the rehabilitation professional will increase patients' functional capacity.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillaume Prieur, PT, PhD
- Phone Number: +33630038824
- Email: guillaume.prieur@ch-havre.fr
Study Contact Backup
- Name: Yann Combret, PT, PhD
- Phone Number: +33686327255
- Email: yann.combret@ch-havre.fr
Study Locations
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Brussels, Belgium, 1070
- Not yet recruiting
- Hôpital Erasme Route de Lennick 808
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Contact:
- Mathieu Tits, PT
- Phone Number: 0474/365056
- Email: Mathieu.Tits@erasme.ulb.ac.be
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Le Coudray, France, 28630
- Not yet recruiting
- Centre Hospitalier de Chartres
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Contact:
- Gaëtan BADRE, Infirmier recherche clinique
- Phone Number: 0237303030 0237303030
- Email: gbadre@ch-chartres.fr
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Valence, France, 26000
- Not yet recruiting
- Centre Hospitalier de Valence
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Contact:
- Baptiste Fontanille, MKDE
- Email: bfontanille@ch-valence.fr
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Normandy
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Le Havre, Normandy, France, 76290
- Recruiting
- Groupe Hospitalier Du Havre
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Principal Investigator:
- Guillaume Prieur
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
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).
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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.
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Sham Comparator: control
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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SPPB
Time Frame: Within 24 hours of admission and within 48 hours prior to discharge from hospital.
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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.
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Within 24 hours of admission and within 48 hours prior to discharge from hospital.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Volume and intensity of physical activity
Time Frame: Within 24 hours of admission and within 48 hours prior to discharge from hospital.
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The number of steps per day and the number of movements per minute will be measured.An accelerometer will be placed on the wrist of the non-dominant limb.
Data will be measured 24 hours a day.
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Within 24 hours of admission and within 48 hours prior to discharge from hospital.
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functional independancy
Time Frame: Within 24 hours of admission and within 48 hours prior to discharge from hospital.
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Will be measured using the Barthel Index, based on the patient's level of independancy during the week prior to hospitalization and upon discharge from the hospital.
The Barthel Index assesses a person's ability to perform ten essential activities of daily living.
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Within 24 hours of admission and within 48 hours prior to discharge from hospital.
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Patient compliance to the prescribed exercises
Time Frame: Within 24 hours of baseline and within 48 hours prior to discharge from hospital
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Compliance will be measured using a compliance record sheet.
This will enable us to note whether the exercises have been performed, and if so, the number of times per day, the schedule, the type, the reason for interruption, and whether or not there has been any pain, rated from 0 to 10.
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Within 24 hours of baseline and within 48 hours prior to discharge from hospital
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falls
Time Frame: Within 24 hours of baseline and within 48 hours prior to discharge from hospital ; and at 3 months after discharge.
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number of falls during hospitalization
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Within 24 hours of baseline and within 48 hours prior to discharge from hospital ; and at 3 months after discharge.
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Volume and type of rehabilitation in-hospital
Time Frame: Within 24 hours of baseline and within 48 hours prior to discharge from hospital
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performed by physiotherapist
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Within 24 hours of baseline and within 48 hours prior to discharge from hospital
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The volume and location of rehabilitation
Time Frame: at 3 months after discharge
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performed by rehabilitation professionals after discharge
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at 3 months after discharge
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Health-related Quality of life
Time Frame: 24 hours after admission, 48 hours before discharge, and 3 months after hospitalization
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mesured by EuroQol(5-5).
It assesses quality of life according to five main dimensions: mobility, independence, daily activities, pain and discomfort, anxiety, and depression.
Each dimension is assessed on a five-point severity scale.
The score ranges from 0 to 100 (best possible health)
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24 hours after admission, 48 hours before discharge, and 3 months after hospitalization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillaume Prieur, PT, PhD, Groupe Hospitalier Du Havre
- Principal Investigator: Léa Bansard, PT, MSc, Groupe Hospitalier Du Havre
- Study Director: Yann Combret, PT, PhD, Groupe Hospitalier Du Havre
- Study Chair: Clément Medrinal, Prof., Groupe Hospitalier Du Havre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25.01855.000458
- PHRIP-23-0006 (Other Grant/Funding Number: DGOS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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