Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients

NCT03195127 | Completed Results

• 2 other identifiers: HP-00047963R03AG045100
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiration, Artificial; Critical Illness; Chronic Disease; Exercise Therapy; Rehabilitation; Physical Therapy Modalities

Keywords

Physical Therapy Modalities; Rehabilitation; Exercise Therapy; Critical Illness; Respiration, Artificial; Chronic Disease

Outcome Measures

Primary Outcomes (4)

• Functional Assessment: Handgrip

  Handgrip strength will be reported in kilograms

  Upon completing of study, up to 56 days

• Functional Assessment: Short Physical Performance Battery (SPPB)

  Short Physical Performance Battery will be reported as a score from 0 to 12 from with lower scores indicating a worse outcome

  Upon Completion of study, up to 56 days

• Functional Assessment: 4 Meter Gait Speed

  4 meter gait speed will be reported in meters per second

  Upon completion of study, up to 56 days

• Functional Assessment: 6 Minute Walk Distance

  6 minute walk distance will be reported in feet

  Upon completion of study, up to 56 days

Secondary Outcomes (2)

• Percent of Patients Weaned From Mechanical Ventilation

  Upon completion of study, up to 56 days

• Percent of Patients Discharged Home

  Upon completion of study, up to 56 days

Study Arms (2)

multimodal physical therapy

EXPERIMENTAL

Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills.

Other: multimodal physical therapy

Usual care

NO INTERVENTION

Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.

Interventions

multimodal physical therapy OTHER

Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist

multimodal physical therapy

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

U of Maryland, Baltimore, Professional Schools IRB

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Verceles AC, Wells CL, Sorkin JD, Terrin ML, Beans J, Jenkins T, Goldberg AP. A multimodal rehabilitation program for patients with ICU acquired weakness improves ventilator weaning and discharge home. J Crit Care. 2018 Oct;47:204-210. doi: 10.1016/j.jcrc.2018.07.006. Epub 2018 Jul 11.

  PMID: 30025227 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration; Critical Illness; Chronic Disease

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Results Point of Contact

• Title: Avelino C. Verceles, M.D., M.S.
• Organization: University of Maryland, Baltimore

avercele@medicine.umaryland.edu

4103288141

Study Officials

• Avelino C Verceles, MD,MS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Up to 75 patients will be screened with a goal of enrolling 40 for participate in the intervention trial (20 in the multimodal treatment arm and 20 in a group receiving usual care).

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 22, 2017
• Study Start: June 28, 2011
• Primary Completion: July 31, 2015
• Study Completion: February 1, 2017
• Last Updated: May 10, 2023
• Results First Posted: February 8, 2022

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)