A Study Promoting Critical Illness Recovery in the Elderly

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome; Critical Care; Critical Illness
• Interventions: Device: cycle ergometry

• Registration Number: NCT02963558
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-15
• Study Start: 2017-05-30
• Primary Completion: 2020-09-11
• Study Completion: 2021-03-11
• Status Verified: 2024-05
• Results First Submitted: 2024-06-27
• Results First Submitted QC: 2024-10-17
• Last Update Submitted: 2024-10-17
• Results First Posted: 2024-10-18
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	cycle ergometry	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients in the Intervention Arm Who Are Able to Undergo a Cycling Session	up to 48 hours after randomization	Feasibility will be assessed by quantifying the ability to apply the MOTOmed device for at least a 15-minute session within 48 hours of randomization and meeting safety criteria.

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	hospital discharge, month 3, month 6	screening instrument for mild cognitive dysfunction; range 0-30; lower score means more cognitive impairment
Quad Strength	ICU Discharge, Hospital discharge	Measurement of quadriceps strength while sitting.
Short Physical Performance Battery (SPPB)	Hospital discharge (through study completion, on average day 10)	Based on timed measures of standing balance, walking speed, and ability to rise from a chair. Score ranges from 0 to 12. A higher score denotes a better outcome.
Handgrip Strength	ICU Discharge, Hospital discharge (through study completion, on average day 10)	Assessed with a Jamar hand-held dynamometer.
Mobility Assessment Tool-short Form (MAT-sf)	Day 0, ICU discharge, Hospital discharge	A scoring system from 30 to 80 with 80 meaning higher physcial function
Short Form-36	hospital discharge	Assesses quality of life. Score for each part of the questionnaire ranges from 0 to 100. Data will be collected for the following parts: Physical functioning, Role Limited Due to Physical Health, Role Limited Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, General Health. For each of these a higher score means better function/less impariment in regards to each item.
Muscle Ultrasound--tibialis Anterior Depth	day 0, day 3, day 5, ICU discharge, Hospital Discharge	The study team is measuring the percentage of the size of the cross-sectional area of the tibialis anterior. Day 0 for everyone is 100% (starting point). The study team is measuring the percentage of that starting point at other time points.
Muscle Ultrasound--echogenicity in the Tibialis Anterior	day 0, day 3, day 5, ICU discharge, Hospital Discharge	Obtain preliminary data to estimate the treatment effect size. Echogenicity is a measure called the "grey scale measure". Scores range from 0-255. A higher score is brighter/more white on ultrasound. A lower score is darker. Think of this as exposure on a black and white picture.
Muscle Ultrasound--muscle Depth Quadriceps	day 0, day 3, day 5, ICU discharge, Hospital Discharge	The study team is measuring the percentage of the size of the cross-sectional area of the quadriceps. Day 0 for everyone is 100% (starting point). The study team is measuring the percentage of that starting point at other time points.
Muscle Ultrasound--muscle Size CSA of Rectus Femoris Muscle	day 0, day 3, day 5, ICU discharge, Hospital Discharge	The study team is measuring the percentage of the size of the cross-sectional area of the rectus femoris. Day 0 for everyone is 100% (starting point). The study team is measuring the percentage of that starting point at other time points.
Muscle Ultrasound--echogenicity in the Rectus Femoris Muscle	day 0, day 3, day 5, ICU discharge, Hospital Discharge	Obtain preliminary data to estimate the treatment effect size. Echogenicity is a measure called the "grey scale measure". Scores range from 0-255. A higher score is brighter/more white on ultrasound. A lower score is darker. Think of this as exposure on a black and white picture.

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States