Cyclo-Ergometry in the Patient With Acute Respiratory Distress Syndrome

NCT ID: NCT06226428

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-12-18

Brief 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.

Detailed Description

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. Each additional day of bed rest is associated with a 3 to 11% decrease in the strength of both peripheral and respiratory muscles, which translates into difficulty in weaning from mechanical ventilation, longer stay in the Intensive Care Unit and in the hospital in general, as well as an increase in morbidity and mortality. Similarly, in the first 24 hours after initiation of mechanical ventilation, diaphragmatic atrophy or dysfunction occurs, predisposing to prolonged mechanical ventilation. The need for ventilatory support for more than 48 hours has been associated with greater morbidity and mortality at hospital discharge, and survivors present greater disability and deterioration in their quality of life.

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. Most of the programs described in the literature include patients requiring extracorporeal membrane oxygenation, mainly in the pre-transplantation situation, and to a lesser extent patients with acute respiratory distress syndrome. They are characterized by the individual and progressive performance of functional activities of lesser to greater difficulty, starting with passive exercises of joint range, active and active-resisted exercises while the patients are in decubitus, progressing in some cases to sitting at the edge of the bed and less frequently to standing.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cyclo-ergonometry program group

• Mobility activities in bed (turning, pelvic elevation and sitting), standing, transfers and walking.
• Progressive strength training of upper and lower limbs (2 days/week), by performing isometric exercises, strengthening with multi-resistance elastic bands or multi-weight dumbbells.
• Cycloergometry, using the MotoMed Letto 2 device, with a progressive pattern, starting with 5 minutes and lasting up to 30 minutes. It will be performed once a day, during working days (Monday to Friday) until discharge from the intensive care unit, and at a modified Borg intensity of 2-3 (Light).

Group Type: EXPERIMENTAL

Bed cyclo-ergonometry

Intervention Type: OTHER

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).

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

Intervention Type: OTHER

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

Progressive upper and lower limb strength training

Intervention Type: OTHER

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

Usual treatment group

• Mobility activities in bed (turning, pelvic elevation and sitting), standing, transfers and walking.
• Progressive strength training of upper and lower limbs (2 days/week), by performing isometric exercises, strengthening with multi-resistance elastic bands or multi-weight dumbbells.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

Progressive upper and lower limb strength training

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Progressive upper and lower limb strength training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient 18 years of age or older
• Alert and cooperative (RASS agitation-sedation between -1 and +1).
• Able to give informed consent (or authorize a family member) to be randomly assigned to receive the cyclo-ergometry program or conventional physiotherapy treatment.
• With or without connection to mechanical ventilation (via orotracheal tube or tracheostomy).
• Clinically stable (cardio-vascular, respiratory, neurological).
• With an inspired oxygen fraction less than or equal to 0.6 and requiring minimal ventilatory support (positive end-expiratory pressure less than or equal to 10 cm H2O).

Exclusion Criteria

• Patients with pre-existing neuromuscular disease, spinal cord injury, cardiorespiratory arrest, stroke, patients with contraindications for mobility, pregnant women, advanced dementia or patients with life expectancy of less than 6 months or any situation that contraindicates the performance of cycloergometry.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogipuzkoa Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asociación Instituto Biogipuzkoa

Donostia / San Sebastian, Guipuzcoa, Spain

Countries

Spain

Other Identifiers

MUGI-cu

Identifier Type: -

Identifier Source: org_study_id