NCT01881477

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1.5 years

First QC Date

October 10, 2012

Last Update Submit

June 17, 2013

Conditions

Keywords

immobilizationphysical therapyintensive carebed restmovement

Outcome Measures

Primary Outcomes (2)

  • Range of motion

    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

    6 months

Secondary Outcomes (1)

  • Functional capacity

    6 months

Other Outcomes (3)

  • Days of mechanical ventilation

    6 months

  • Hospital stay

    6 months

  • ICU stay

    6 months

Study Arms (1)

kinetics modalities

EXPERIMENTAL

passive movements active movements assisted movements resisted movements

Procedure: kinetics modalities

Interventions

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.

Also known as: physiotherapy exercises, physical activity
kinetics modalities

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alejandra Mondragón

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Asthenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alejandra Mondragón

    University CES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 10, 2012

First Posted

June 19, 2013

Study Start

August 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations