Clinical trial NCT02963558: A Study Promoting Critical Illness Recovery in the Elderly
Official title: ASPIRE: A Study Promoting Critical Illness Recovery in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Critical Illness
Critical Care
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2016-11-15
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients in the Intervention Arm Who Are Able to Undergo a Cycling Session
timeFrame: up to 48 hours after randomization
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Intensive Care Unit (ICU) discharge (through study completion, on average day 10)
measure: Short Physical Performance Battery (SPPB)
timeFrame: Hospital discharge (through study completion, on average day 10)
measure: Handgrip Strength
timeFrame: ICU Discharge, Hospital discharge (through study completion, on average day 10)
measure: Mobility Assessment Tool-short Form (MAT-sf)
timeFrame: Day 0, ICU discharge, Hospital discharge
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: hospital discharge, month 3, month 6
measure: Quad Strength
timeFrame: ICU Discharge, Hospital discharge
measure: Short Form-36
timeFrame: hospital discharge
measure: Muscle Ultrasound--tibialis Anterior Depth
timeFrame: day 0, day 3, day 5, ICU discharge, Hospital Discharge
measure: Muscle Ultrasound--echogenicity in the Tibialis Anterior
timeFrame: day 0, day 3, day 5, ICU discharge, Hospital Discharge
measure: Muscle Ultrasound--muscle Depth Quadriceps
timeFrame: day 0, day 3, day 5, ICU discharge, Hospital Discharge
measure: Muscle Ultrasound--muscle Size CSA of Rectus Femoris Muscle
timeFrame: day 0, day 3, day 5, ICU discharge, Hospital Discharge
measure: Muscle Ultrasound--echogenicity in the Rectus Femoris Muscle
timeFrame: day 0, day 3, day 5, ICU discharge, Hospital Discharge
Other outcomes:
measure: Accelerometer Activity Monitoring Results
timeFrame: Up through two weeks after discharge
measure: Number of Hospital Readmissions
timeFrame: up to 6 months
measure: Number of Emergency Department Visits
timeFrame: up to 6 months
measure: Number of Ventilator Free Days
timeFrame: Up to 28 days from hospital admission or hospital discharge, whichever is first
measure: Translational Outcomes
timeFrame: up to 6 months
measure: Hospital Length of Stay
timeFrame: Hospital discharge (through study completion, on average day 10)
measure: Mortality
timeFrame: up through 6 months post-discharge
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: ICU discharge (through study completion, on average day 7)
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: D. Clark Files, MD
role: PRINCIPAL_INVESTIGATOR
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