Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness

NCT04058977 | Withdrawn Phase 1

• 1 other identifier: 46072
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients surviving critical illness experience significant skeletal muscle dysfunction and weakness. Muscle atrophy suffered during critical illness has a long-term impact on the functionality and mobility of these individuals. As a result, individuals surviving critical illness have a significant reduction in quality of life, even up to 5 years post discharge. Research including large randomized controls demonstrates that rehabilitation focused on active mobilization may positively influence patient outcomes. Thus, early mobilization is an important intervention that has many purported benefits. Current rehabilitation practice in the intensive care unit (ICU) and recommendations from clinical practice guidelines such as the Society of Critical Care Medicine, PADIS Guidelines support these interventions to reduce the detrimental effects of immobilization during critical illness. Early mobilization is routinely thought of as standard of care for patients admitted for acute respiratory distress syndrome and sepsis. However, a significant number of recent randomized controlled trials implementing early rehabilitation and mobilization interventions fail to demonstrate immediate or long-term benefits.10,11,18,19 Interesting, active mobilization and rehabilitation analyzed in systematic review had no impact on mortality and "no consistent effects of function, quality of life and ICU or hospital length of stay."18 There are a few potential explanations for interventions not leading to reduction in impairment or functional benefit. Scientific Premise: From our preliminary data (Figure 1) and my clinical experience, a significant cause of the physical impairments in these patients is reductions in muscular power. Muscular power is a critical determinant of functional mobility.20 Preliminary data demonstrate that lower extremity muscle power is significantly reduced in this population and furthermore, these deficits are strongly correlated to physical function. Muscle power training is a potential therapeutic intervention that could lead to more robust improvements in physical function. This concept has been explored extensively in community-dwelling older adults. A recent systematic review of controlled trials demonstrates that power training is superior to traditional resistance training at improving functional performance when comparing the two training modalities.21 Furthermore, power training is feasible for older adults and clinical populations of Parkinson's Disease, Stroke, and frailty.22-27 Thus the feasibility and pragmatic nature of power training is not a concern. Of interest, a randomized controlled trial was completed in institutionalized frail nonagenarians (\>85 years or older).27 In this study, no patients drop-out of study due to power training and significant benefits in function were achieved.27 Therefore, the investigators propose a interventional trial to study the effect of a standardized muscle power training program for patients admitted to the ICU for critical illness.

Conditions

Critical Illness; Muscle Atrophy or Weakness

Outcome Measures

Primary Outcomes (1)

• Short Performance Physical Battery

  This outcome measure is scored from 0-12 with lower scores representing disability and higher scores representing better physical function. This test has three components including balance, chair rise time, and habitual gait speed. There is a pre-defined scoring system with participants scoring 0-4 on each test, higher representing better function. These individual components can then be further analysed based on continuous variables of five repetitions of chair rise and habitual 4-meter gait speed. Faster times to complete the the chair-rise test and faster gait speed represents better physical function.

  6-month follow-up

Secondary Outcomes (2)

• Quality of life: Eq-5D

  6-month follow-up

• Six minute walk test (6-mwt)

  6-month follow-up

Study Arms (2)

Power training

EXPERIMENTAL

Randomized to early power training with standardized exercise progression plus standard of care

Other: Power training

Standard of Care

NO INTERVENTION

Standard of care

Interventions

Power training OTHER

Progressive exercise protocol with focus on velocity of movement

Power training

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• admitted to medicine ICU
• acute respiratory failure or ARDS
• sepsis
• anticipated \>48 hours MV

You may not qualify if:

• acute neurologic infarct
• non-ambulatory prior to hospitalization
• pregnant

Sponsors & Collaborators

• Kirby Mayer: lead
• Nathan Johnson, PT, PhD: collaborator
• Ashley Montgomery-Yates, MD: collaborator
• Amy Pastva, PT, PhD: collaborator
• Peter E. Morris, MD: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy; Asthenia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Kirby P Mayer, DPT

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Personnel performing outcomes will be blinded to study group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate Research Assistant

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: December 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)