A Study Promoting Critical Illness Recovery in the Elderly (ASPIRE)

Wake Forest University (WFU)

Status: Completed

Conditions: Critical Care; Critical Illness; Acute Respiratory Distress Syndrome

Treatments: Device: cycle ergometry

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02963558

IRB00039558

1R03AG060076 (U.S. NIH Grant/Contract)

5UL1TR001420-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This proposal will test the hypothesis that EARLY application of a novel early rehabilitation therapy in critically ill patients will improve functional outcomes, and change the functional trajectory of this population. A pilot study of early mobilization with a cycle ergometer will be performed and translate into humans the pre-clinical mechanisms that may mediate the effects of early mobility. A second phase of the study was added in September 2019, which will focus on clinical outcomes.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥55 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; absolute weight >= 150 kg
• 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; pelvic and/or LE fracture, LE bypass surgery)
• Pregnancy
• Unable to speak English
• Use of continuous neuromuscular blockade
• Temporary Pacemaker or Swan Ganz catheter or femoral ECMO catheter/IABP
• Rhabdomyolysis with most recent CK >5000
• Clinical diagnosis of dementia on medication
• Moribund
• Possible Exclusion: If the patient is on spine precautions, a discussion with the spine team will be necessary to determine eligibility for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while 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 PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.

Treatment:

Device: cycle ergometry

Usual Care

No Intervention group

Description:

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 regular physicians.