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

Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness: A Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Critical Illness; Muscle Atrophy or Weakness
• Intervention / Treatment: Other: Power training

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard of Care; Standard of care
EXPERIMENTAL: Power training; Randomized to early power training with standardized exercise progression plus standard of care	Other: Power training; Progressive exercise protocol with focus on velocity of movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life: Eq-5D	The Eq-5d is a validate quality of life questionnaire that the participant completes. It has five components each on a scale from 1 to 5, which higher scores representing poor or worse quality of life. A total score can be assessed out of possible 25.	6-month follow-up
Six minute walk test (6-mwt)	The 6-mwt is a test of physical function and strength in which participant walks as far as possible in six-minutes. Final distance is analysed as a continuous variable with higher distances being better.	6-month follow-up

Collaborators and Investigators

• Sponsor: Kirby Mayer
• Collaborators: Nathan Johnson, PT, PhD; Ashley Montgomery-Yates, MD; Amy Pastva, PT, PhD; Peter E. Morris, MD
• Investigators: Principal Investigator: Kirby P Mayer, DPT, University of Kentucky

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (ACTUAL): August 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy; Critical Illness
• Other Study ID Numbers: 46072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following completion of the proposed experiments, data sharing will be accomplished in a timely fashion via dissemination through publications in peer-reviewed journals and through presentations at national and international meetings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No