N/A
Completed N=33
Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients
Respiration, Artificial · Critical Illness · Chronic Disease · Exercise Therapy
Source: ClinicalTrials.gov NCT03195127 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Functional Assessment: Handgrip — 3.6; 1.3 kg
Summary
As the general population ages and technology advances, many who suffer from catastrophic critical illness (i.e. septic shock, respiratory failure, Acute Respiratory Disease Syndrome) survive only to find themselves severely physically debilitated and compromised from a pulmonary standpoint, requiring assistance from a mechanical ventilator in order to breath. Oftentimes, these patients require a long course of physical rehabilitation and ventilator support. These patients frequently remain ventilator dependent for greater than 3 weeks, and are thus referred to as requiring prolonged mechanical ventilation (PMV).
Older patients are at significantly higher risk for requiring PMV for reasons that are not entirely clear, but which may include physical deconditioning, impaired cardiopulmonary physiology, and cognitive or behavioral disturbances.
The purpose of this study is two fold: 1. to characterize the functional phenotype of ventilator dependent, and recently ventilated patients with respect to general strength, endurance, balance, and pulmonary functioning and body composition. 2. To pilot test a rehabilitation protocol that targets improving this populations disabilities through exercises focused on improving strength, endurance, balance, and pulmonary functioning.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Assessment: Handgrip |
3.6; 1.3 | — |
| PRIMARY Functional Assessment: Short Physical Performance Battery (SPPB) |
3.6; 1.3 | — |
| PRIMARY Functional Assessment: 4 Meter Gait Speed |
0.13; 0.07 | — |
| PRIMARY Functional Assessment: 6 Minute Walk Distance |
40.6; 19.9 | — |
| SECONDARY Percent of Patients Weaned From Mechanical Ventilation |
13; 7 | — |
| SECONDARY Percent of Patients Discharged Home |
8; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Age 20 or greater
- Received prolonged mechanical ventilation for >= 14 days during their last acute hospitalization
- Has received mechanical ventilation within the past 14 days for at least 6 hours in a 24 hour period
- Tracheostomy in place
- Subject is able to follow commands, and can give written or witnessed verbal consent in English
- Subject is eligible for physical rehabilitation
- All four limbs intact and mobile
Exclusion Criteria
- Acute superimposed cardiopulmonary disease (ie.pulmonary edema, Stage IV congestive heart failure, COPD exacerbation, asthma attack, untreated infections, other)
- Severe functional impairment or physical impairment to rehabilitation
- Dementia, cognitive impairment (see attached description outlining cognitive impairment under additional documents)
Data sourced from ClinicalTrials.gov (NCT03195127). 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. Informational only — not medical advice.