Trial Outcomes & Findings for A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU (NCT NCT02003053)

Results Overview

The number of patients tolerating Inspiratory Muscle Training or Sham.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)

Results posted on

2018-09-07

Participant milestones
Measure	Inspiratory Muscle Training In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer	Sham In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Inpsiratory Muscle Training n=4 Participants In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer	Sham n=3 Participants In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer	Total n=7 Participants Total of all reporting groups
Age, Continuous	49.0 years STANDARD_DEVIATION 16.9 • n=4 Participants	54.33 years STANDARD_DEVIATION 3.78 • n=3 Participants	51.29 years STANDARD_DEVIATION 11.28 • n=7 Participants
Sex: Female, Male Female	NA Participants n=4 Participants	NA Participants n=3 Participants	NA Participants n=7 Participants
Sex: Female, Male Male	NA Participants n=4 Participants	NA Participants n=3 Participants	NA Participants n=7 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	3 participants n=3 Participants	7 participants n=7 Participants

Timeframe: Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)

The number of patients tolerating Inspiratory Muscle Training or Sham.

Outcome measures
Measure	Inspiratory Muscle Training n=4 Participants In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer	Sham n=3 Participants In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer
Safety and Feasibility of Inspiratory Muscle Training	3 Participants	3 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Kentucky

Phone: 8593235045