Physical DeconditioningICUPTNCT01881477
Effect of Therapeutic Modalities on the Physical Fitness and Functional Capacity in Critical Patient
A study testing kinetics modalities in people with Physical Deconditioning and Weakness, run by CES University at 1 site in Colombia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Deconditioning, Weakness
- What is being tested?
- kinetics modalities
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Physical Deconditioning, Weakness
- Being tested
- kinetics modalities
- Keywords
- immobilization, physical therapy, intensive care, bed rest, movement
- Medical subject headings
- Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinetics modalitiesProcedure or surgery
Also called physiotherapy exercises, physical activity
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.
| Study group | Role | What they receive |
|---|---|---|
| kinetics modalities | Experimental | passive movements active movements assisted movements resisted movements Receives: Procedure: kinetics modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Evaluate the range of motion in the joints(Shoulder, Knee, Ankle) of the user before and after the physiotherapy intervention
Measured: 6 months
hand grip strength
Measured: 6 months
Secondary outcomes (1)
Functional capacity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DeconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Alejandra Mondragon Barrera, CES University
- Investigators
- Alejandra Mondragón, Principal investigator, University CES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881477
- Sponsor's protocol ID
- ICUPT
- Acronym
- ICUPT
- Status last verified
- Jun 2013
- First submitted
- 10 Oct 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Modalities on the Physical Fitness and Functional Capacity in Critical Patient
- ClinicalTrials.gov ID
- NCT01881477
- Acronym / sponsor ID
- ICUPT / ICUPT
- Conditions
- Physical Deconditioning, Weakness
- Keywords
- immobilization, physical therapy, intensive care, bed rest, movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kinetics modalities | Experimental | Procedure: kinetics modalitiespassive movements active movements assisted movements resisted movements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kinetics modalitiesAlso: physiotherapy exercises, physical activityThe 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. | Procedure or surgery | kinetics modalities |
Primary outcome
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
hand grip strength
Time frame: 6 months
1 secondary outcome
Functional capacity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
Related trials for Physical Deconditioning
RecruitingPhase 2
Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.
Hospital Associated Disability, Immobility
Not yet recruiting
Supplemental Mobility
Aging, Functional Recovery
Not yet recruiting
Development of a Power Training Program to Improve Mobility in Older Veterans
Physical Deconditioning, Mobility Decline
Recruiting
Promoting Increased Physical Activity in Hospitalised Older Adults
Hospital-associated Deconditioning
RecruitingObservational study
Evaluation of the Effect of a Physical Activity Recovery Stay
Children With Cerebral Palsy, Children With Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandra Mondragón principal investigator
University CES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinetics modalities in people with Physical Deconditioning and Weakness, run by CES University at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.