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

Primary Purpose

Critical Illness, Muscle Atrophy or Weakness

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Power training
Sponsored by
Kirby Mayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Power training

Standard of Care

Arm Description

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

Standard of care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 14, 2019
Last Updated
October 26, 2020
Sponsor
Kirby Mayer
Collaborators
Nathan Johnson, PT, PhD, Ashley Montgomery-Yates, MD, Amy Pastva, PT, PhD, Peter E. Morris, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04058977
Brief Title
Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness
Acronym
POWER
Official Title
Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn prior to participant enrollment due to funding status
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kirby Mayer
Collaborators
Nathan Johnson, PT, PhD, Ashley Montgomery-Yates, MD, Amy Pastva, PT, PhD, Peter E. Morris, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Muscle Atrophy or Weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Personnel performing outcomes will be blinded to study group
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Power training
Arm Type
Experimental
Arm Description
Randomized to early power training with standardized exercise progression plus standard of care
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Other
Intervention Name(s)
Power training
Intervention Description
Progressive exercise protocol with focus on velocity of movement
Primary Outcome Measure Information:
Title
Short Performance Physical Battery
Description
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.
Time Frame
6-month follow-up
Secondary Outcome Measure Information:
Title
Quality of life: Eq-5D
Description
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.
Time Frame
6-month follow-up
Title
Six minute walk test (6-mwt)
Description
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.
Time Frame
6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirby P Mayer, DPT
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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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Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness

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