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Cyclo-Ergometry in the Patient With Acute Respiratory Distress Syndrome

NCT06226428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-02-01

No results posted yet for this study

Summary

In March 2020 the World Health Organization declares the Coronavirus disease pandemic 2019. Intensive Care Units deal entirely with patients with pneumonia complicated by Acute Respiratory Distress Syndrome, requiring aggressive respiratory treatments with long periods of connection to mechanical ventilation, sedation and immobilization, contributing to the onset of acquired critical patient muscle weakness (IAPD). IUCD is a frequent complication in intensive care units, with an incidence of 11-67%¹. Of multifactorial cause, immobilization or "bed-rest", the use of corticosteroids and neuromuscular blocking agents have been described as factors directly related to this syndrome.

Several studies have shown that mobilization of the patient with acute respiratory distress syndrome, even with extracorporeal membrane oxygenation, is safe, feasible and beneficial for the patient. Bedside cyclo-ergometry has been associated with a reduction in the degree of sarcopenia, contributing to the recovery of the critically ill patient. Several studies document that bed cyclo-ergometry is safe and feasible in critically ill patients within the first week of admission to intensive care, but few clinical trials exist.

Conditions

  • Coronavirus

Interventions

OTHER

Bed cyclo-ergonometry

The MotoMed Letto 2 device will be used, with a progressive pattern, starting at 5 minutes and lasting up to 30 minutes. It will be performed once a day, during weekdays (Monday to Friday) until discharge from the intensive care unit, and at a modified Borg intensity of 2-3 (Light).

OTHER

Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking.

Bed mobility activities (turning, pelvic elevation and sitting), standing, transfers and walking.

OTHER

Progressive upper and lower limb strength training

Performing isometric exercises, strengthening with multi-resistance elastic bands or multi-weight dumbbells.

Sponsors & Collaborators

  • Biogipuzkoa Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-02-18
Completion
2023-12-18

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06226428 on ClinicalTrials.gov