Inspiratory Muscle Training Post-Liver Transplant

Primary outcomes

1. Change from baseline Maximal Inspiratory Pressure (MIP) at 4 weeks and 8 weeks.

   Time frame: Baseline, 4 weeks, and 8 weeks.

   MIP is a measure of inspiratory muscle strength . Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.

   Each measurement will be performed 3 times with the maximal score recorded.

2. Change from baseline Forced Expiratory Volume (FEV1) at 4 weeks and 8 weeks

   Time frame: Baseline, 4th week, and 8th week

   FEV1 is how much air can be exhaled during a forced exhalation at one second. Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.

   Each measurement will be performed 3 times with the maximal score recorded.

3. Change from baseline 6 Minute Walk Distance at 4 weeks and 8 weeks.

   Time frame: Baseline, 4 weeks, and 8 weeks

   In a 100ft. straight hallway the subject will walk back and forth, from one end to the other, as many times as they can in 6 minutes. The subject will have the option to rest at any time during the six minutes. The clock will keep running whether the subject is walking or resting. The subject will be provided standardized cues to prevent unequal encouragement. The distance walked over the 6 minutes will be recorded. Throughout the walking test, the investigator will be walking nearby to guard patient from loss of balance or fall.

4. Change from baseline 30 Second Chair Stand Repetitions at 4 weeks and 8 weeks.

   Time frame: Baseline, 4 weeks, and 8 weeks

   From a straight back chair the subject will come to a complete stand and then return to sitting with arms across chest. The number of times the subject can stand in 30 seconds will be recorded. The investigator will be standing nearby guarding the subject to protect from any loss of balance or fall.

5. Change from baseline Chronic Liver Disease Questionnaire (CLDQ) Score at 4 weeks and 8 weeks.

   Time frame: Baseline, 4 weeks, and 8 weeks

   This is a paper and pencil questionnaire consisting of 29 items in 6 domains: 1) Abdominal Symptoms 2) Activity: eating habits and movement of heavy objects 3) Emotional Function 4) Fatigue: perception of decreased energy and sleepiness 5) Systemic symptoms 6) Worry: concerns regarding disease progression and family. Summary scores for each domain range from 1(most impaired) to 7 (least impaired). All items refer to the previous 2 weeks. Higher scores indicate less impairment.

6. Change from baseline Karnovsky Performance Status Score at 4 weeks and 8 weeks.

   Time frame: Baseline, 4 weeks, and 8 weeks

   This is a paper pencil questionnaire measuring functional impairment. The questionnaire is divided into three groups for classifying patient's ability to work, to carry on normal activity, and to care for themselves. The groups are further divided into eleven categories covering all level so functioning from normal (100) to dead (0). The lower the Karnovsky score, the worse the functional ability and survival for most serious illness. The liver transplant team records this measure prior to transplant. We will obtained pre-transplant scores from medical record for use in correlational analysis. This measure will also performed at baseline and post-testing.

7. Change from baseline Sustained Maximal Inspiratory Pressure (SMIP) at 4 weeks and 8 weeks.

   Time frame: Baseline, 4 weeks, and 8 weeks

   SMIP will be measured from residual volume to total lung capacity representing single breath work/endurance. Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.

8. Change from baseline Inspiratory Duration (ID) at 4 weeks and 8 weeks

   Time frame: Baseline, 4 weeks, and 8 weeks

   ID is the inspiratory flow during maximal inspiration effort with an isokinetic like resistance from the mouthpiece. Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.

9. Change from baseline Maximal Expiratory Pressure (MEP) at 4 weeks and 8 weeks.

   Time frame: Baseline, 4 weeks, and 8 weeks

   MEP is a measure of expiratory muscle strength measured from total lung capacity. Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.

10. Change from baseline Forced Vital Capacity (FVC) at 4 weeks and 8 weeks.

    Time frame: Baseline, 4 weeks, 8 weeks.

    FVC is the total amount of air exhaled during a pulmonary function test. Expiratory testing will be performed using the Jones Satellite Spirometer (Jones Medical Instrument Company, Oakbrook, Illinois 65021) Measurements will be performed in the manner described using American Thoracic Society guidelines with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.

    Each measurement will be performed 3 times with the maximal score recorded.

11. Change from baseline Forced Expiratory Flow (FEF25-75%) at 4weeks and 8 weeks.

    Time frame: Baseline, 4 weeks, 8 weeks.

    FEF25-75% is the flow rate at 25% to 75% of Forced Vital Capacity. Expiratory testing will be performed using the Jones Satellite Spirometer (Jones Medical Instrument Company, Oakbrook, Illinois 65021) Measurements will be performed in the manner described using American Thoracic Society guidelines with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.

    Each measurement will be performed 3 times with the maximal score recorded.

12. Change from baseline Peak Expiratory Flow Rate (PEFR) at 4weeks and 8 weeks.

    Time frame: Baseline, 4 weeks, 8 weeks.

    PEFR is a measure of how fast a person can exhale. Expiratory testing will be performed using the Jones Satellite Spirometer (Jones Medical Instrument Company, Oakbrook, Illinois 65021) Measurements will be performed in the manner described using American Thoracic Society guidelines with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.

    Each measurement will be performed 3 times with the maximal score recorded.