Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

August 6, 2019 updated by: Gemma Rialp, Hospital Son Llatzer

Functional and Motor Effects of an Early Cycloergometric Physiotherapy Program in Critically Ill Patients With Invasive Mechanical Ventilation. A Randomized Controlled Trial

Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cycloergometric treatment is described to improve the functional and motor status of critically ill subjects. However, there are few studies comparing cycloergometric physiotherapy and conventional physiotherapy in intensive care subjects under mechanical ventilation. The most relevant of these studies conducted by Burtin et al showed beneficial effects of cycloergometric treatment. However, the duration of the physiotherapy sessions in this study differed between groups as cycloergometric group received a double daily dose of treatment. It is known that the intensity of physiotherapy also affects the functional and motor status.

For this reason, the investigators designed a randomized controlled study with early cycloergometric or conventional treatment, with the same intensity between groups to analyze objective functional and motor endpoints.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 07198
        • Recruiting
        • Hospital Son Llàtzer
        • Contact:
        • Sub-Investigator:
          • Catalina Morey, Phty
        • Sub-Investigator:
          • Noelia Calvo, Phty
        • Sub-Investigator:
          • Catalina Forteza, M.D.
        • Sub-Investigator:
          • Maria Romero, M.D.
        • Sub-Investigator:
          • Alvaro Perez, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Criteria of functional independence before hospital admission (Barthel scale > 70 points).
  • Invasive mechanical ventilation < 72 hours.
  • Signed informed consent.

Exclusion Criteria:

  • Neuromuscular disease (peripheric or central neurologic disorder).
  • Presumed fatal evolution in 48 hours.
  • Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism).
  • Admission due to cardiac arrest.
  • Pregnancy.
  • Thrombopenia less than 50.000.
  • Severe agitation.
  • Hemodynamic instability with noradrenaline requirements greater than 1 mcg/kg/min.
  • Fraction of inspired Oxygen (FiO2) requirements greater that 0.55 and respiratory rate greater than 30 bpm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cycle ergometer physiotherapy
15 minutes of cycle ergometer physiotherapy plus 15 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit
Procedure: Cycle ergometer physiotherapy
15 minutes of cyclo ergometer physiotherapy with MOTOmed ® Letto 2 device with passive, motor-assisted and active-resisted exercise of the lower and upper extremity, and 15 minutes of conventional physiotherapy
Other Names:
  • MOTOmed ® Letto 2
ACTIVE_COMPARATOR: Conventional physiotherapy
30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit
Procedure: Conventional physiotherapy
30 minutes of conventional physiotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Walking test distance at six minutes
Time Frame: At hospital discharge, with an expected average of 4 weeks after hospital admission
At hospital discharge, with an expected average of 4 weeks after hospital admission
Short Form-36 Health Survey (SF-36), physical functioning section
Time Frame: At 28 days after hospital discharge, that is an expected average of 8 weeks
At 28 days after hospital discharge, that is an expected average of 8 weeks
Basic activities of daily living score (BADL)
Time Frame: At 28 days after hospital discharge, that is an expected average of 8 weeks
At 28 days after hospital discharge, that is an expected average of 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lung Functional Testing
Time Frame: At the end of hospital stay, with an expected average of 5 weeks
At the end of hospital stay, with an expected average of 5 weeks
Presence of intensive care acquired paresis (Medical Research Council score < 48 points)
Time Frame: During ICU admission and ICU discharge, with an expected average of 2 weeks
During ICU admission and ICU discharge, with an expected average of 2 weeks
ICU mobilization scale
Time Frame: During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge
During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge
Isometric quadriceps force (N/kg)
Time Frame: During ICU admission, with an expected average of 2 weeks
Quadriceps strength will be measured with a handheld dynamometer with patients in supine position and 30º of knee flexion.
During ICU admission, with an expected average of 2 weeks
Walking test distance at six minutes
Time Frame: At 28 days and at 6 months after hospital discharge, that is up to 1 year
At 28 days and at 6 months after hospital discharge, that is up to 1 year
Short Form-36 Health Survey (SF-36), physical functioning section
Time Frame: At 7 days and at 6 months after hospital discharge, that is up to 1 year
At 7 days and at 6 months after hospital discharge, that is up to 1 year
Basic activities of daily living score (BADL)
Time Frame: At 7 days and at 6 months after hospital discharge, that is up to 1 year
At 7 days and at 6 months after hospital discharge, that is up to 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Pulse Oximeter Oxygen Saturation (SpO2) between end and initial values after physiotherapy sessions
Time Frame: ICU admission, with an expected average of 2 weeks
ICU admission, with an expected average of 2 weeks
Change in respiratory rate between end and initial values after physiotherapy sessions
Time Frame: ICU admission, with an expected average of 2 weeks
Respiratory rate
ICU admission, with an expected average of 2 weeks
Change in heart rate between end and initial values after physiotherapy sessions
Time Frame: ICU admission, with an expected average of 2 weeks
ICU admission, with an expected average of 2 weeks
Change in mean blood pressure between end and initial values after physiotherapy sessions
Time Frame: ICU admission, with an expected average of 2 weeks
ICU admission, with an expected average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Son Llatzer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gemma Rialp, M.D., IDISPA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CYCLE-ICU-001

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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