Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT02963558
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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Notify Me55 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Physical Function: Able to walk 4 m (with or without assistive device)
Exclusion criteria
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
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.
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.
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.
Time frame: ICU Discharge, Hospital discharge (through study completion, on average day 10)
Assessed with a Jamar hand-held dynamometer.
Time frame: Day 0, ICU discharge, Hospital discharge
A scoring system from 30 to 80 with 80 meaning higher physcial function
Time frame: hospital discharge, month 3, month 6
screening instrument for mild cognitive dysfunction; range 0-30; lower score means more cognitive impairment
Time frame: ICU Discharge, Hospital discharge
Measurement of quadriceps strength while sitting.
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.
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.
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.
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.
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.
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.
Time frame: Up through two weeks after discharge
Used to determine activity.
Time frame: up to 6 months
Time frame: up to 6 months
Time frame: Up to 28 days from hospital admission or hospital discharge, whichever is first
Time frame: up to 6 months
MuRF1, NFKB, myofiber size and type, etc
Time frame: Hospital discharge (through study completion, on average day 10)
Number of days
Time frame: up through 6 months post-discharge
total number affected
Time frame: ICU discharge (through study completion, on average day 7)
Number of days
Wake Forest University Health Sciences
Other
ASPIRE: A Study Promoting Critical Illness Recovery in the Elderly
Acronym: ASPIRE
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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