Project 4B: Lower Extremity Strength Training in ICU Patients

As a participant in the study, the following will take place: Assignment to study groups: a
random assignment will be done to one of two groups by a list generated by a computer
program, much like flipping a coin. One group of subjects will be assigned to an effective
muscle stimulation group and the second group will be assigned to a group that will receive
ineffective stimulation (Control or Sham). Muscle stimulation will be performed with a Niveus
medical stimulator on both quadriceps muscle groups for 30 minutes, five days per week. The
stimulator will be individually adjusted in terms of intensity of stimulation to elicit a
visible or palpable quadriceps muscle contraction. Four contractions per minute will be
performed for a total of approximately 120 contractions per 30 minute treatment. Isometric
Muscle strength testing: All subjects will undergo isometric muscle strength testing. Maximal
isometric twitch strength will be measured by placing the subjects' dominant leg in a frame
that will hold the knee at 60°. A cuff will be placed around the patient's ankle and will be
connected to an electronic dynamometer with the cable. A magnetic nerve stimulator will be
used over the body of the quadriceps muscle to stimulate the muscle.

Inclusion criteria

1. Presence in the surgery or trauma ICU,

2. age of ≥18 years,

3. received MV for 3 day and expected to survive ICU stay,

4. ability to obtain informed consent from patient or legally authorized representative,

5. approval of an ICU attending for patient to participate.

Exclusion criteria

1. Have an uncontrollable source of sepsis (e.g., irreversible disease state,
unresectable dead bowel),

2. are receiving "comfort care" or have advanced care directives limiting resuscitative
efforts,

3. have an implanted electronic device (pacemaker/defibrillator/insulin pump, etc.)

4. have known HIV infection with CD4 count < 200 cells/mm3,

5. are organ transplant recipients on immunosuppressive agent(s),

6. have a known pregnancy,

7. history of stroke with weakness,

8. Inability to walk without assistance prior to ICU admission (excluding the use of cane
or walker)

9. lower-extremity amputations, rheumatic or severe osteoarthritis of any joint in the
lower extremity,

10. Unrepaired hip fracture, unstable cervical spine or other bone diseases

11. arterial or venous insufficiency in the lower extremity,

12. have prior arrangements to be transferred to other facilities before 28 days of
treatment,

13. have an unstable or "difficult airway" at 14 days of ICU care, predicted to last for
more than 72 hours,

14. are on vasopressor or vasodilatory agents as a continuous infusion at more than a
"renal dose,"

15. have severe cardiac dysrhythmias,

16. have acute coronary syndrome,

17. have pulmonary contraindications (pneumo/hemothorax, flail chest),

18. 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,

19. 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

20. Allergic to lidocaine

21. High risk of bleeding secondary to organic conditions or medication

22. Any anatomical difficulty obtaining biopsy (such a being very overweight)

23. CPR on admission

24. Full dose anticoagulation therapy (ex. Heparin infusion, full anticoagulation dose
enoxaparin, Coumadin/Warfarin/Jantoven/Marevan/Waran, and Argatroban).

25. 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

26. any other factor in the investigators' judgment that would unnecessarily increase the
risk to the patient.