Project 4B: Lower Extremity Strength Training in ICU Patients

Completed · Not applicable

Conditions studied: Sepsis

In brief

The purpose of this research study is to see if electrical stimulation of the leg muscles will improve strength in patients receiving mechanical ventilation in the intensive care unit (ICU). ICU care frequently results in chronically critically ill (CCI) patients. Some CCI patients develop persistent inflammation/immunosuppression and catabolism syndrome (PICS), and they have morbid long-term outcomes. CCI patients with PICS often develop severe limb muscle atrophy, weakness and accelerated protein catabolism. Limb muscle dysfunction in PICS is due to many factors including sepsis/inflammation, proteolysis, apoptosis, and inactivity. Despite the seriousness of limb muscle weakness in CCI patients receiving mechanical ventilation, little is known about exercise strategies to treat this problem. There is limited knowledge about how strength training impacts inflammation and catabolism in CCI patients. In addition, an assessment of the effect of exercise on markers of inflammation and protein catabolism on muscle samples obtained with biopsy techniques and venous blood samples will be performed. This project will further understanding of how treating CCI-related muscle weakness with strength training cannot only improve muscle function, but also potentially blunt the inflammation and catabolism of PICS.

Key facts

Study ID

NCT02467023

Run by

University of Florida

People needed

5

Starts

2015-09-01

Expected to finish

2016-07-15

Last updated by the study team

2018-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence in the surgery or trauma ICU,
• age of ≥18 years,
• received MV for 3 day and expected to survive ICU stay,
• ability to obtain informed consent from patient or legally authorized representative,
• approval of an ICU attending for patient to participate.

You may not qualify if…

• Have an uncontrollable source of sepsis (e.g., irreversible disease state, unresectable dead bowel),
• are receiving "comfort care" or have advanced care directives limiting resuscitative efforts,
• have an implanted electronic device (pacemaker/defibrillator/insulin pump, etc.)
• have known HIV infection with CD4 count < 200 cells/mm3,
• are organ transplant recipients on immunosuppressive agent(s),
• have a known pregnancy,
• history of stroke with weakness,
• Inability to walk without assistance prior to ICU admission (excluding the use of cane or walker)
• lower-extremity amputations, rheumatic or severe osteoarthritis of any joint in the lower extremity,
• Unrepaired hip fracture, unstable cervical spine or other bone diseases
• arterial or venous insufficiency in the lower extremity,
• have prior arrangements to be transferred to other facilities before 28 days of treatment,
• have an unstable or "difficult airway" at 14 days of ICU care, predicted to last for more than 72 hours,
• are on vasopressor or vasodilatory agents as a continuous infusion at more than a "renal dose,"
• have severe cardiac dysrhythmias,
• have acute coronary syndrome,
• have pulmonary contraindications (pneumo/hemothorax, flail chest),
• have persistent surgical problems in the post-operative period (serious postoperative bleeding, wound dehiscence, etc.)-when and if these problems resolve and the patient meets other entry criteria, they will be eligible to be recruited for participation,
• have active neuromuscular diseases that would prevent or interfere with responding to strength training (e.g., amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy or other dystrophies and myopathies), and
• Allergic to lidocaine
• High risk of bleeding secondary to organic conditions or medication
• Any anatomical difficulty obtaining biopsy (such a being very overweight)
• CPR on admission
• Full dose anticoagulation therapy (ex. Heparin infusion, full anticoagulation dose enoxaparin, Coumadin/Warfarin/Jantoven/Marevan/Waran, and Argatroban).
• Patient on antiplatelet therapy and medicine such as Plavix (also known as Clopidogrel, Clopilet, and Ceruvin), Aggrenox (also known as aspirin with Dipyridamol), Ticlid (also known as ticlopidine), Agrylin or Xagrid (also known as Anagrelide). Of note, aspirin is not an exclusion criteria, as long as that is the only anti-platelet medication the patient is receiving. In addition, other non steroidal anti-inflammatory agents-NSAIDS (Ibuprofen, Naproxen, Indomethicin or other anti-inflammatories) are not a contraindication to the muscle biopsy procedure and

Where it is running

• UF Health Shands Hospital at the University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.