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Treatment of Critical Illness Polyneuromyopathy (Do-It-Now)

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ClinicalTrials.gov Identifier: NCT01058421
Recruitment Status : Completed
First Posted : January 28, 2010
Results First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Respiratory Failure
Interventions Procedure: intensive physical therapy
Procedure: control group
Enrollment 120
Recruitment Details  
Pre-assignment Details Deceased subjects were removed from starting period subject numbers for subsequent outcome periods in each cohort. All non-deceased subjects were included in period outcomes analysis and categorized as death in subsequent period, lost to follow-up, remained in hospital or other facility.
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28. Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Period Title: 1 Month Outcomes
Started 59 61
Completed 20 19
Not Completed 39 42
Reason Not Completed
Death             10             6
Lost to Follow-up             8             7
Remained in Hospital             5             12
Remained in Other Facility             16             17
Period Title: 3 Month Outcomes
Started [1] 49 [2] 55 [3]
Completed 29 29
Not Completed 20 26
Reason Not Completed
Death             3             5
Lost to Follow-up             12             11
Remained in Hospital             0             2
Remained in Other Facility             5             8
[1]
Deceased subjects were not included in subsequent Period beginning subject started totals.
[2]
59 (Subjects started Period 1) minus 10 (deceased subjects during Period 1) = 49 started Period 2.
[3]
61 (Subjects started Period 1) minus 6 (deceased subjects during Period 1) = 55 started Period 2.
Period Title: 6 Month Outcomes
Started [1] 46 [2] 50 [3]
Completed 27 24
Not Completed 19 26
Reason Not Completed
Death             2             2
Lost to Follow-up             16             21
Remained in Other Facility             1             3
[1]
Deceased subjects were not included in subsequent Period beginning subject started totals.
[2]
55 (subjects started Period 1) minus 13 (deceased subjects in Periods 1 & 2) = 46 started Period 3.
[3]
61 (subjects started Period 1) minus 11 (deceased subjects in Periods 1 & 2) = 50 started Period 3.
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group Total
Hide Arm/Group Description Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28. Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28. Total of all reporting groups
Overall Number of Baseline Participants 59 61 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 59 participants 61 participants 120 participants
56
(42 to 70)
49
(34 to 64)
53
(34 to 70)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 61 participants 120 participants
Female 24 26 50
Male 35 35 70
1.Primary Outcome
Title The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10
Hide Description The CS-PFP-10 provides an overall score and scores for upper body strength, upper body flexibility, lower body strength, balance and coordination, and endurance. The test is used to assess an individual's overall capacity to carry out activities of daily living by measuring and quantifying 10 typical activities including sweeping a floor, transferring clothes from a washer to a dryer, and carrying groceries. Tasks are quantified using time alone, time and weight, and distance. This test provides a realistic and practical measure of movement capacity and ability to accomplish sustained activity. CS-PFP-10 scores are scored from 0 to 100, with higher scores indicating better function. If patients remained in the hospital or in a long-term care facility a the time of assessment, then received a score of 0. All tests were conducted in a standardized physical therapy laboratory by a physical therapist formally trained in conducting the CS-PFP-10 and blinded to group/arm assignment.
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
41 of 59 subjects were analyzed in the Intensive Treatment Group (20 completed outcomes testing + 5 remained in hospital + 16 remained in another facility = 41 subjects). 48 of 61 Standard of Care Group subjects were analyzed (19 completed outcomes testing + 12 remained in hospital + 17 remained in another facility = 48).
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description:
Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Overall Number of Participants Analyzed 41 48
Mean (Standard Error)
Unit of Measure: score
19.0  (3.7) 20.9  (4.1)
2.Secondary Outcome
Title ICU-free Days
Hide Description Number of ICU-free days at Day 28.
Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description:
Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Overall Number of Participants Analyzed 59 61
Median (Inter-Quartile Range)
Unit of Measure: Days
13
(3 to 18)
11
(4 to 18)
3.Secondary Outcome
Title ICU Length of Stay
Hide Description Median ICU length of stay through Day 28
Time Frame Total Days through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description:
Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Overall Number of Participants Analyzed 59 61
Median (Inter-Quartile Range)
Unit of Measure: Days
15
(10 to 25)
16
(10 to 24)
4.Secondary Outcome
Title Mechanical Ventilation Duration
Hide Description The total number of ventilated days from hospital admission to extubation, death or discharge over the complete duration of study participation, up to 180 days.
Time Frame up to 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description:
Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Overall Number of Participants Analyzed 59 61
Median (Inter-Quartile Range)
Unit of Measure: Days
10
(7 to 18)
10
(7 to 19)
5.Secondary Outcome
Title Hospital Free Days
Hide Description [Not Specified]
Time Frame Through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description:
Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Overall Number of Participants Analyzed 59 61
Median (Inter-Quartile Range)
Unit of Measure: Days
7
(0 to 12)
7
(0 to 14)
6.Secondary Outcome
Title Hospital Length of Stay
Hide Description The total number of hospital days during study participation, up to 180 days.
Time Frame up to 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description:
Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Overall Number of Participants Analyzed 59 61
Median (Inter-Quartile Range)
Unit of Measure: Days
21
(16 to 32)
21
(14 to 38)
7.Secondary Outcome
Title Discharged to Home
Hide Description Percentage of subjects discharged to home from study hospital
Time Frame Through Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description:
Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Overall Number of Participants Analyzed 59 61
Measure Type: Number
Unit of Measure: percentage of participants
51 49
8.Secondary Outcome
Title Institution Free Days
Hide Description Median number of days subjects were alive and free of hospitalization or living in a longer-term care, rehabilitation, or skilled nursing facility.
Time Frame At Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Deceased subjects were not included in subsequent Period beginning subject started totals.

59 (Subjects started Period 1) minus 10 (deceased subjects during Period 1) = 49 started Period 2.

61 (Subjects started Period 1) minus 6 (deceased subjects during Period 1) = 55 started Period 2.

Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description:
Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Overall Number of Participants Analyzed 49 55
Median (Inter-Quartile Range)
Unit of Measure: Days
61
(39 to 73)
56
(33 to 75)
9.Secondary Outcome
Title Institution Free Days
Hide Description Median number of days subjects were alive and free of hospitalization or living in a long-term care, rehabilitation, or skilled nursing facility.
Time Frame Day 180
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Deceased subjects were not included in subsequent Period beginning subject started totals.

55 (subjects started Period 1) minus 13 (deceased subjects in Periods 1 & 2) = 46 started Period 3.

61 (subjects started Period 1) minus 11 (deceased subjects in Periods 1 & 2) = 50 started Period 3.

Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description:
Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Overall Number of Participants Analyzed 46 50
Median (Inter-Quartile Range)
Unit of Measure: Days
151
(129 to 163)
146
(123 to 165)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Hide Arm/Group Description Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28. Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
All-Cause Mortality
Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/59 (0.00%)      0/61 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intensive Physical Therapy Treatment Group Standard of Care Physical Therapy Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/59 (1.69%)      1/61 (1.64%)    
Musculoskeletal and connective tissue disorders     
Polyarthralgia * [1]  1/59 (1.69%)  1 0/61 (0.00%)  0
Nervous system disorders     
Syncope * [2]  0/59 (0.00%)  0 1/61 (1.64%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One subject was readmitted to study hospital for 2 day stay after initial hospital stay due to polyarthralgia that was possibly related to physical therapy interventions.
[2]
One subject had a syncopal episode during a physical therapy session.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Marc Moss
Organization: University of Colorado
Phone: 303-724-6079
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01058421     History of Changes
Other Study ID Numbers: 09-0214
First Submitted: January 26, 2010
First Posted: January 28, 2010
Results First Submitted: July 22, 2016
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017