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

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ClinicalTrials.gov Identifier: NCT04058977
Recruitment Status : Withdrawn (Withdrawn prior to participant enrollment due to funding status)
First Posted : August 16, 2019
Last Update Posted : October 28, 2020
Sponsor:
Collaborators:
Nathan Johnson, PT, PhD
Ashley Montgomery-Yates, MD
Amy Pastva, PT, PhD
Peter E. Morris, MD
Information provided by (Responsible Party):
Kirby Mayer, University of Kentucky

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.


Condition or disease Intervention/treatment Phase
Critical Illness Muscle Atrophy or Weakness Other: Power training Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Personnel performing outcomes will be blinded to study group
Primary Purpose: Treatment
Official Title: Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness: A Randomized Controlled Trial
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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

No Intervention: Standard of Care
Standard of care



Primary Outcome Measures :
  1. Short Performance Physical Battery [ Time Frame: 6-month follow-up ]

    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.



Secondary Outcome Measures :
  1. Quality of life: Eq-5D [ Time Frame: 6-month follow-up ]
    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.

  2. Six minute walk test (6-mwt) [ Time Frame: 6-month follow-up ]
    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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058977


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Kirby Mayer
Nathan Johnson, PT, PhD
Ashley Montgomery-Yates, MD
Amy Pastva, PT, PhD
Peter E. Morris, MD
Investigators
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Principal Investigator: Kirby P Mayer, DPT University of Kentucky
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Responsible Party: Kirby Mayer, Graduate Research Assistant, University of Kentucky
ClinicalTrials.gov Identifier: NCT04058977    
Other Study ID Numbers: 46072
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Atrophy
Atrophy
Critical Illness
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases