N/A
N=24
A Study Promoting Critical Illness Recovery in the Elderly
Acute Respiratory Distress Syndrome · Critical Illness · Critical Care
Bottom Line
View on ClinicalTrials.gov: NCT02963558 ↗Enrolled (actual)
24
Serious AEs
27.3%
Results posted
Oct 2024
Primary outcome: Primary: Number of Patients in the Intervention Arm Who Are Able to Undergo a Cycling Session — 13; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cycle ergometry (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients in the Intervention Arm Who Are Able to Undergo a Cycling Session |
13; 0 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
3; 4.25 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
3; 4.25 | — |
| SECONDARY Handgrip Strength |
11.33; 11.33; 14.33; 8.67 | — |
| SECONDARY Mobility Assessment Tool-short Form (MAT-sf) |
55.4; 49.12; 42.8; 54.0; 45.4; 47 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
18.5; 19 | — |
| SECONDARY Quad Strength |
11.6; 12.37; 12.9; 13.1 | — |
| SECONDARY Short Form-36 |
15; 20; 0; 0; 0; 33.33 | — |
| SECONDARY Muscle Ultrasound--tibialis Anterior Depth |
100; 100; 94; 102; 98; 102 | — |
| SECONDARY Muscle Ultrasound--echogenicity in the Tibialis Anterior |
76.07; 74.94; 74.98; 73.62; 78.03; 74.78 | — |
| SECONDARY Muscle Ultrasound--muscle Depth Quadriceps |
100; 100; 90; 94; 102; 76 | — |
| SECONDARY Muscle Ultrasound--muscle Size CSA of Rectus Femoris Muscle |
100; 100; 95; 95; 91; 85 | — |
| SECONDARY Muscle Ultrasound--echogenicity in the Rectus Femoris Muscle |
73.34; 70.41; 74.34; 67.73; 71.78; 69.01 | — |
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.
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 20 mm Hg)
- BMI>45; absolute weight >= 150 kg
- Inability to cycle (including absent limbs, body length 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
Data sourced from ClinicalTrials.gov (NCT02963558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.