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Completed

NCT Number: NCT02963558

A Study Promoting Critical Illness Recovery in the Elderly

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cycle ergometry

Device

The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling.

Other names: MOTOmed

Primary outcomes

  1. Number of Patients in the Intervention Arm Who Are Able to Undergo a Cycling Session

    Time frame: 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 outcomes

  1. Short Physical Performance Battery (SPPB)

    Time frame: Intensive Care Unit (ICU) discharge (through study completion, on average day 10)

    Based on timed measures of standing balance, walking speed, and ability to rise from a chair. Scores range from 0-12. A higher score denotes a better outcome.

  2. Short Physical Performance Battery (SPPB)

    Time frame: 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.

  3. Handgrip Strength

    Time frame: ICU Discharge, Hospital discharge (through study completion, on average day 10)

    Assessed with a Jamar hand-held dynamometer.

  4. Mobility Assessment Tool-short Form (MAT-sf)

    Time frame: Day 0, ICU discharge, Hospital discharge

    A scoring system from 30 to 80 with 80 meaning higher physcial function

  5. Montreal Cognitive Assessment (MoCA)

    Time frame: hospital discharge, month 3, month 6

    screening instrument for mild cognitive dysfunction; range 0-30; lower score means more cognitive impairment

  6. Quad Strength

    Time frame: ICU Discharge, Hospital discharge

    Measurement of quadriceps strength while sitting.

  7. Short Form-36

    Time frame: 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.

  8. Muscle Ultrasound--tibialis Anterior Depth

    Time frame: 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.

  9. Muscle Ultrasound--echogenicity in the Tibialis Anterior

    Time frame: 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.

  10. Muscle Ultrasound--muscle Depth Quadriceps

    Time frame: 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.

  11. Muscle Ultrasound--muscle Size CSA of Rectus Femoris Muscle

    Time frame: 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.

  12. Muscle Ultrasound--echogenicity in the Rectus Femoris Muscle

    Time frame: 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.

Other outcomes

  1. Accelerometer Activity Monitoring Results

    Time frame: Up through two weeks after discharge

    Used to determine activity.

  2. Number of Hospital Readmissions

    Time frame: up to 6 months

  3. Number of Emergency Department Visits

    Time frame: up to 6 months

  4. Number of Ventilator Free Days

    Time frame: Up to 28 days from hospital admission or hospital discharge, whichever is first

  5. Translational Outcomes

    Time frame: up to 6 months

    MuRF1, NFKB, myofiber size and type, etc

  6. Hospital Length of Stay

    Time frame: Hospital discharge (through study completion, on average day 10)

    Number of days

  7. Mortality

    Time frame: up through 6 months post-discharge

    total number affected

  8. Intensive Care Unit (ICU) Length of Stay

    Time frame: ICU discharge (through study completion, on average day 7)

    Number of days

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute on Aging (NIA)

Registry information

Official study title

ASPIRE: A Study Promoting Critical Illness Recovery in the Elderly

Acronym: ASPIRE

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Nov 15, 2016
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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