Trial Outcomes & Findings for Treatment of Critical Illness Polyneuromyopathy (NCT NCT01058421)

NCT ID: NCT01058421

Last Updated: 2017-04-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2017-04-27

Participant Flow

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.

Participant milestones

Measure	Intensive Physical Therapy Treatment Group Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
1 Month Outcomes STARTED	59	61
1 Month Outcomes COMPLETED	20	19
1 Month Outcomes NOT COMPLETED	39	42
3 Month Outcomes STARTED	49	55
3 Month Outcomes COMPLETED	29	29
3 Month Outcomes NOT COMPLETED	20	26
6 Month Outcomes STARTED	46	50
6 Month Outcomes COMPLETED	27	24
6 Month Outcomes NOT COMPLETED	19	26

Reasons for withdrawal

Measure	Intensive Physical Therapy Treatment Group Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
1 Month Outcomes Death	10	6
1 Month Outcomes Lost to Follow-up	8	7
1 Month Outcomes Remained in Hospital	5	12
1 Month Outcomes Remained in Other Facility	16	17
3 Month Outcomes Death	3	5
3 Month Outcomes Lost to Follow-up	12	11
3 Month Outcomes Remained in Hospital	0	2
3 Month Outcomes Remained in Other Facility	5	8
6 Month Outcomes Death	2	2
6 Month Outcomes Lost to Follow-up	16	21
6 Month Outcomes Remained in Other Facility	1	3

Baseline Characteristics

Treatment of Critical Illness Polyneuromyopathy

Baseline characteristics by cohort

Measure	Intensive Physical Therapy Treatment Group n=59 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=61 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.	Total n=120 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	49 years n=7 Participants	53 years n=5 Participants
Sex/Gender, Customized Female	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants
Sex/Gender, Customized Male	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: 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).

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.

Outcome measures

Measure	Intensive Physical Therapy Treatment Group n=41 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=48 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
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	19.0 score Standard Error 3.7	20.9 score Standard Error 4.1

SECONDARY outcome

Timeframe: Day 28

Number of ICU-free days at Day 28.

Outcome measures

Measure	Intensive Physical Therapy Treatment Group n=59 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=61 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
ICU-free Days	13 Days Interval 3.0 to 18.0	11 Days Interval 4.0 to 18.0

SECONDARY outcome

Timeframe: Total Days through Day 28

Median ICU length of stay through Day 28

Outcome measures

Measure	Intensive Physical Therapy Treatment Group n=59 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=61 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
ICU Length of Stay	15 Days Interval 10.0 to 25.0	16 Days Interval 10.0 to 24.0

SECONDARY outcome

Timeframe: up to 180 days

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.

Outcome measures

Measure	Intensive Physical Therapy Treatment Group n=59 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=61 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Mechanical Ventilation Duration	10 Days Interval 7.0 to 18.0	10 Days Interval 7.0 to 19.0

SECONDARY outcome

Timeframe: Through Day 28

Outcome measures

Measure	Intensive Physical Therapy Treatment Group n=59 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=61 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Hospital Free Days	7 Days Interval 0.0 to 12.0	7 Days Interval 0.0 to 14.0

SECONDARY outcome

Timeframe: up to 180 days

The total number of hospital days during study participation, up to 180 days.

Outcome measures

Measure	Intensive Physical Therapy Treatment Group n=59 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=61 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Hospital Length of Stay	21 Days Interval 16.0 to 32.0	21 Days Interval 14.0 to 38.0

SECONDARY outcome

Timeframe: Through Day 28

Percentage of subjects discharged to home from study hospital

Outcome measures

Measure	Intensive Physical Therapy Treatment Group n=59 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=61 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Discharged to Home	51 percentage of participants	49 percentage of participants

SECONDARY outcome

Timeframe: At Day 90

Population: 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.

Median number of days subjects were alive and free of hospitalization or living in a longer-term care, rehabilitation, or skilled nursing facility.

Outcome measures

Measure	Intensive Physical Therapy Treatment Group n=49 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=55 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Institution Free Days	61 Days Interval 39.0 to 73.0	56 Days Interval 33.0 to 75.0

SECONDARY outcome

Timeframe: Day 180

Population: 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.

Median number of days subjects were alive and free of hospitalization or living in a long-term care, rehabilitation, or skilled nursing facility.

Outcome measures

Measure	Intensive Physical Therapy Treatment Group n=46 Participants Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=50 Participants Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Institution Free Days	151 Days Interval 129.0 to 163.0	146 Days Interval 123.0 to 165.0

Adverse Events

Intensive Physical Therapy Treatment Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care Physical Therapy Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intensive Physical Therapy Treatment Group n=59 participants at risk Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.	Standard of Care Physical Therapy Group n=61 participants at risk Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
Nervous system disorders Syncope	0.00% 0/59 • 6 months	1.6% 1/61 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Polyarthralgia	1.7% 1/59 • Number of events 1 • 6 months	0.00% 0/61 • 6 months

Additional Information

Dr. Marc Moss

University of Colorado

Phone: 303-724-6079

Email: marc.moss@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place