Effect of Therapeutic Modalities on the Physical Fitness and Functional Capacity in Critical Patient (ICUPT)

June 17, 2013 updated by: Monica Alejandra Mondragon Barrera, CES University

CONTEXT: The physical deconditioning in the critically ill patient is favored by prolonged immobilization, which compromises the ability to function. This perpetuates the stays in hospital and intensive care units (ICU). To combat this, there physiotherapy intervention methods that can reverse or reduce their occurrence.

OBJECTIVE: The purpose of this research is to determine the effects of passive movements, assisted active and resisted, and changes of position on grip strength, joint mobility and functional capacity in patients in ICU.

METHODS: A quasi-experimental intervention, before and after, no control group, in which 40 patients in an adult ICU in Medellin, receive physiotherapy care. Electrogoniometry, dynamometry and functional independence measure, will be made before the intervention and serial assessments every four days, until discharge from ICU.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Intervention study, prospective, comparative before-after, no control group, The sample was chosen for convenience and consisted of all patients during the eight months of the execution of research, met the inclusion and exclusion criteria, ie 23 patients. The recruitment of patients was very limited due to the complexity of their health condition. We included patients older than 18 years, with over 24 hours of stay in the intensive care unit, who were begin physical therapy. We excluded those who were hemodynamically unstable heart disease or severe, severe symptomatic stenosis, decompensated heart failure, uncontrolled arrhythmias, high blood pressure (systolic greater than 200 mmHg, diastolic greater than 110 mmHg), mean arterial pressure below 60 mmHg , uncontrolled systemic disease or end stage; limb with unstable or acute musculoskeletal injury, severe dementia or aggressive behavior that does not allow performing the procedure properly, injury or infection of the central nervous system and neuromuscular diseases which take motor control extremity, patients with inotropic or vasoactive treatment associated with severe sepsis or multisystem dysfunction.

To assess muscle strength in the grip using the Baseline ® hand dynamometer. The range of motion were measured using the electronic goniometer Biometrics ®. Functional capacity was assessed using the Functional Independence Measure (FIM) (8), an instrument that allows the classification of individuals according to the score in independent, partially dependent or dependents.

Range of motion was measured articular shoulder abduction and flexion, hip abduction, dorsiflexion standing collar. Dynamometry was applied during the initial evaluation or after the patient's consciousness allowed, bilaterally, choosing the best score of three. The FIM, was filled out at the foot of the patient bed, by the evaluators. Were followed for clinical outcome in four days of starting treatment, and dynamometry applied only if the state of consciousness allowed. Evaluations were completed once the patient was transferred to the Special Care Unit (SCU).

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • 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 Locations

    • Antioquia
      • Medellín, Antioquia, Colombia
        • Alejandra Mondragón

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with more than 24 hours of stay in the Intensive Care Unit, who is going to start physical therapy.
  • A patient who has a family to sign the informed consent and who can provide information for the processing of the instrument.

Exclusion Criteria:

  • Heart diseases hemodynamically unstable or severe.
  • High blood pressure (systolic, + 200 mm Hg, diastolic, +110 mm Hg).
  • Mean arterial pressure below 60 mm Hg.
  • Uncontrolled systemic disease or terminal condition.
  • Tip with unstable musculoskeletal injury or acute.
  • Severe dementia or behaviors that do not allow to perform the procedure properly.
  • Injuries and / or infection of the central nervous system.
  • Neuromuscular diseases in which motor control lost limbs.
  • Patient in ICU inotropic and vasoactive treatment high associated to sepsis and / or severe multisystem dysfunction medication order can not mobilize.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kinetics modalities
passive movements active movements assisted movements resisted movements

The duration of the intervention will be approximately 30 minutes to 1 hour and will take place 5 days a week. They constantly monitor the vital signs and signs of exercise intolerance.

The intervention consists of four levels of complexity. The progression in kinetic patterns based on muscle strength during exercise Kinetic methods begin with passive movements and patients are assisted in the movement slowly until they are active, culminating in movements against resistance, in all joints, with a minimum of 10 repetitions for each joint.

Additionally, it promotes the adoption and sitting positions long and short legged and walk.

Other Names:
  • physical activity
  • physiotherapy exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: 6 months
Evaluate the range of motion in the joints(Shoulder, Knee, Ankle) of the user before and after the physiotherapy intervention
6 months
hand grip strength
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional capacity
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Days of mechanical ventilation
Time Frame: 6 months
6 months
Hospital stay
Time Frame: 6 months
6 months
ICU stay
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Alejandra Mondragón, University CES

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

August 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • ICUPT

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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