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Recruiting NCT07492745

Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay.

No phase Interventional Inpatients Frail

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vibrating reminder, Control group.
Who it may be relevant to
Registry conditions: Inpatients, Frail. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay : a Multicenter Randomised Controlled Double Blind Study.

Overview

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

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.

Interventions

  • Device Vibrating reminder
    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.
  • Device Control group
    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.

Primary outcome measures

  • SPPB [Time frame: Within 24 hours of admission and within 48 hours prior to discharge from hospital.]
Secondary outcome measures (7)
  • Volume and intensity of physical activity [Time frame: Within 24 hours of admission and within 48 hours prior to discharge from hospital.]
  • functional independancy [Time frame: Within 24 hours of admission and within 48 hours prior to discharge from hospital.]
  • Patient compliance to the prescribed exercises [Time frame: Within 24 hours of baseline and within 48 hours prior to discharge from hospital]
  • falls [Time frame: 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 [Time frame: Within 24 hours of baseline and within 48 hours prior to discharge from hospital]
  • The volume and location of rehabilitation [Time frame: at 3 months after discharge]
  • Health-related Quality of life [Time frame: 24 hours after admission, 48 hours before discharge, and 3 months after hospitalization]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

France · 3 centers
  • Groupe Hospitalier du Havre — Le Havre
  • Centre hospitalier de Chartres — Le Coudray
  • centre hospitalier de Valence — Valence
Belgium · 1 center
  • Hôpital Erasme Route de Lennick 808 — Brussels

Identifiers

NCT: NCT07492745 · 25.01855.000458 · PHRIP-23-0006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗