Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients
Brief Summary: To study all ICU patients with an independent baseline functional status, who experience a critical illness requiring intubation and mechanical ventilation, evaluating the role of protocol-directed, early physical and occupational therapy on the incidence of critical illness associated functional debilitation. Our goal is to hasten the recovery of independent physical functioning as well as to reduce ICU delirium in the group of patients who begin this intervention from the earliest hours of ventilator dependence.


Options:
A: Inclusion Criteria

1. Patients intubated and mechanical ventilated for \< 72 hours
2. Age \> 18 years
3. Baseline independent functional status as assessed by a Barthel Index score \> 70 collected from a proxy reflecting baseline health 2 weeks prior to critical illness

Exclusion Criteria

1. Rapidly evolving neurological/neuromuscular disease
2. Cardiac arrest
3. Irreversible conditions with six month mortality estimated at \> 50%
4. Elevated intracranial pressure
5. Multiple absent limbs (precluding complete musculoskeletal examination)
6. Enrollment in another trial
B: Inclusion Criteria:

* Adult (age \> or = 18) patients admitted to the Medical ICU
* Respiratory failure requiring mechanical ventilation \> or = 5 days
* Reasonable expectation for a subsequent return of mental status

Exclusion Criteria:

* Patient's family, physician, or both not in favor of aggressive treatment of patient or presence of an advanced directive to withhold life-sustaining treatment
* Pregnancy
* Admitted to ICU from outside hospital
* New or pre-existing diagnosis causing current neuromuscular weakness
* Profound and uncorrectable hypokalemia or hypophosphatemia \[K \< 2.5 or P \< 1.0 throughout enrollment window\]
* Inability to assess muscle strength in more than six muscle groups in at least two extremities \[Bilateral amputation (BKA or AKA), severe burns, skin lesions or dressings limiting ability of examiner to access and forcibly resist movement of the patients extremities\]
* Inability to communicate or follow commands of the examiner \[persistent coma, severe MRDD (mental retardation and developmental disabilities) or continuing necessary medication use that impairs consciousness (i.e. narcotics), non-English speaker\]
* Concurrent enrollment in another clinical trial involving steroids \> 20 mg/day prednisone equivalent for \> 3 days, neuromuscular blockade for \> 24 hours or any aminoglycosides.
* Prisoner or other subject where legal surrogate decision maker is in question
C: Inclusion Criteria:

* Age \>18 years AND admitted to critical care unit
* Ventilated \>48-hours (via endotracheal tube) OR received continuous non- invasive ventilation (NIV)/non-invasive continuous positive airways pressure (CPAP)
* Admitted to ICU \> 48-hours and evidence of SIRS
* Glasgow Coma Score (GCS) 15 (of 15) AND Abbreviated Mini-Mental Test Score (AMMTS) \>/= 8 (of 10) on enrolment into rehabilitation programme
* Mobilising on ward to a degree sufficient as to begin a majority of proposed exercises. Clinical stability for observed exercise as judged by trial team is a prerequisite.
* Participant willingness to complete a programme of exercise based therapy aimed at reducing weakness and shortness of breath: subjective weakness or dyspnoea relative to their pre-admission state is implicit

Exclusion Criteria:

* Patients referred for terminal care or prognosis likely to be less than 12-months
* Unstable coronary artery syndrome
* Limb amputation (given special requirement for orthotics/rehabilitation)
* Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance \<100 metres)
* Stroke with hemiparesis (likely need for specialised rehabilitation/stay on stroke unit)
* Severe, disabling locomotor problem or severe burns, which prevent effective participation in the exercises contained in the rehabilitation programme.
* Psychiatric disease necessitating anti-psychotic medication, deliberate drug overdose as the admitting ICU indication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
* Patients undergoing renal haemodialysis (given the associated commitment to outpatient attendance)
* Extra contractual ICU referral (only if distance greater than suitable for twice weekly travel)

Additional exclusion criteria for muscle biopsy samples:

* Coagulopathy e.g. warfarin use
D: Inclusion Criteria:

* Patients will be included if they are adult, patients in a medical and/or surgical ICU receiving treatment for any of the following: respiratory failure or cardiogenic or septic shock.

Exclusion Criteria:

Patients who meet the inclusion criteria will be excluded if they meet any of the following criteria:

* Cumulative ICU time \>5 days in the past 30 days, not including the current ICU stay, as this might create a state of flux regarding patients' cognitive baseline
* Severe cognitive or neurodegenerative diseases that prevent a patient from living independently at baseline, including mental illness requiring institutionalization, acquired or congenital mental retardation, known brain lesions, traumatic brain injury, cerebrovascular accidents with resultant moderate to severe cognitive deficits or ADL dependency, Parkinson's disease, Huntington's disease, severe Alzheimer's disease or dementia of any etiology
* ICU admission post cardiopulmonary resuscitation with suspected anoxic injury
* An active substance abuse or psychotic disorder, or a recent (within the past 6 months) serious suicidal gesture necessitating hospitalization. This exclusion will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact
* Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the follow-up evaluation interviews.
* Overly moribund and not expected to survive for an additional 24 hours and / or withdrawing life support to focus on comfort measures only.
* Prisoners.
* Patients who live further than 200 miles from Nashville and who do not regularly visit the Nashville area.
* Patients who are homeless and have no secondary contact person available. This exclusion will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact
* The onset of the current episode of respiratory failure, cardiogenic shock, or septic shock was \> 72 hours ago.
* Patients who have had cardiac bypass surgery within the past 3 months (including the current hospitalization)

Answer: A