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Recruitment Status : Withdrawn (Withdrawn prior to participant enrollment due to funding status)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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Personnel performing outcomes will be blinded to study group|
|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|
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
- 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.
- 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.
- 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.
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
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Kirby P Mayer, DPT||University of Kentucky|