A Study Promoting Critical Illness Recovery in the Elderly-- Pilot

Patients will be randomized to intervention or control groups. Patients will receive
therapies according to their group assignment until hospital discharge or day 28, whichever
comes first.

The intervention group will receive in-bed cycle ergometry within 48 hours of randomization
if safety criteria are met. In-bed cycle ergometry has been shown to be safe and feasible in
the critically ill and is approved for use in this population. Subjects enrolled in the
intervention arm will be screened at least 5 days per week to evaluate if they meet
pre-defined safety criteria based on other studies of early mobilization and cycling in the
Intensive Care Unit (ICU). Patients will be positioned in the semi-recumbent position for
cycling as per ICU guidelines. The cycler will provide 3 different possible modes of
cycling—passive, active-assisted, and active. The investigators will start with passive
cycling and the patient may progress to active-assisted and active cycling. The goal duration
of cycling will be 30 minutes. Subjects will receive in-bed cycling at least 5 times per week
for the duration of the ICU stay or until day 14, whichever comes first. During cycling and
therapy sessions, the physical therapist will also complete a case report form noting vital
signs, level of mobilization, and other safety measures.

In addition to cycling, the intervention arm will receive early physical therapy (PT). This
physical therapy will be performed according to a protocol of additional ICU and
hospital-administered rehabilitation strategies that were previously developed. Patients will
receive 30 minutes of Physical Therapy (PT) at least 5 times per week when they are
conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10
repetitions per body part daily. Once conscious, subjects will progress through the different
levels of PT with an emphasis on ambulation.

Physical therapy for the intervention arm patients will continue while hospitalized through
day 28. Outpatient therapy will be provided at the discretion of the patient's treating
physicians.

The control group will receive usual care physical therapy as ordered by the treating team
both in the ICU and on the floor through hospital discharge. These subjects will also receive
therapy as outpatients only as ordered by their physicians.

Inclusion Criteria:

- Age ≥60 years old

- Admission to Wake Forest Baptist Medical Center Medical Intensive Care Unit

- Acute Hypoxic respiratory failure on mechanical ventilation for <48 hours with a P:F
ratio of <300 (or equivalent S:F ratio)

- Previously Functional (over past 3 months, as reported by proxy):

Physical Function: Able to walk 4 m (with or without assistive device)

Exclusion Criteria:

- Neuromuscular Disease

- Cardiopulmonary Arrest with return of spontaneous circulation <6 hrs

- Palliative Goals of Care; witholding life-sustaining therapy

- Elevated Intracranial Pressure (>20 mm Hg)

- BMI>45

- Inability to cycle (including absent limbs, body length <1.5m, body habitus not
fitting the cycle, inflammatory arthritis, significant joint problems including
inability to bend arms/legs)

- Pregnancy

- Unable to speak English

- Use of continuous neuromuscular blockade

- Temporary Pacemaker or Swan Ganz catheter

- Rhabdomyolysis with most recent CK >1000

- Deemed ineligible for inclusion per investigator

- Inability to return for follow-up appointments (as assessed by patient/surrogate or
lives >50 miles away from WFBMC)

- Femoral catheter placement

- Clinical diagnosis of dementia on medication

- Living in a skilled nursing facility prior to ICU admission