The Effects of IMT on Exercise Capacity, Dyspnea and Lung Functions in LTx
Primary Purpose
Lung Transplant, Inspiratory Muscle Training
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
inspiratory muscle training
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Lung Transplant focused on measuring rehabilitation, exercise, maximal inspiratory pressure, 6-minute walk test
Eligibility Criteria
Inclusion Criteria:
- a diagnosis of terminally severe lung disease,
- being listed for lung transplantation,
- medically stable,
- had no orthopedic or cardiac problems that would prevent them from exercising
- had no transfer problem to the PR centre.
Exclusion Criteria:
- Malignancy in the last 2 years,
- Other advanced major organ / system dysfunction that can not be treated outside the lung,
- Untreated non-pulmonary infection,
- Disputed medical treatment discontinuity,
- Untreatable psychiatric illness or psychosocial condition that interferes with treatment compliance,
- No appropriate, reliable social support,
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IMT+PR Group
PR group
Arm Description
Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training. In addition standard pulmonary rehabilitation, patients received inspiratory muscle training.
Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training.
Outcomes
Primary Outcome Measures
Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months
The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.
Change from baseline Maximum Expiratory Pressure (MEP) at 3-months
The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.
Change from baseline distance covered in six minute walking test at 3-months
The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk. Before and after the test, oxygen saturation, heart rate, Borg fatigue rating, and walking distance were recorded.
Change from baseline Modified Medical Research Council (mMRC) Dyspnea Scale score at 3-months
Dyspnea perceptions during the activities of daily living were assessed with modified Medical Research Council (mMRC) scale.
Secondary Outcome Measures
Change from baseline Forced Vital Capacity (FVC) at 3-months
It was conducted by using the Sensor Medics model 2400 (Yorba Linda, CA, USA), and according to the American Thoracic Society (ATS) guidelines
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months
It was conducted by using the Sensor Medics model 2400 (Yorba Linda, CA, USA), and according to the American Thoracic Society (ATS) guidelines
Change from baseline alveolar volume ratio of carbonmonoxide diffusion capacity (DLCO/VA) at 3-months
It was performed in the pulmonary function test laboratory using Cosmed Quark PFT (USA) with single breath technique
Full Information
NCT ID
NCT03505697
First Posted
April 7, 2018
Last Updated
April 13, 2018
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03505697
Brief Title
The Effects of IMT on Exercise Capacity, Dyspnea and Lung Functions in LTx
Official Title
The Effects of Inspiratory Muscle Training on Exercise Capacity, Dyspnea and Lung Functions in Lung Transplantation Candidates
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital
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
Inspiratory Muscle Training (IMT), which is used to strengthen the respiratory muscles, is one of the techniques used in PR. It is mostly used in patients with chronic obstructive pulmonary disease, and has been shown to be beneficial for functionality and also for relieving dyspnea perception. It is reported in the guidelines that IMT has additional benefit for endurance in COPD patients. However, there are no studies related to its use and effectiveness in lung transplantation. In this study, we hoped to increase these known benefits by adding IMT to the standard Pulmonary Rehabilitation.
There are two main objectives of this study:
to examine the effect of respiratory muscle training on exercise capacity in lung transplantation candidates,
to compare dyspnea perception and lung function changes between the IMT+PR group and the PR group.
Detailed Description
The patients in the lung transplantation waiting list were included the study. These patients were with severe lung disease requiring transplantation, and that the intervention was undertaken before any lung transplantation. The patients were eligible for inclusion if they have: a diagnosis of terminally severe lung disease, being listed for lung transplantation, medically stable, had no orthopedic or cardiac problems that would prevent them from exercising and had no transfer problem to the PR centre.
Participants who meet the study inclusion criteria and complete the baseline assessments were randomly allocated into one of the two groups: namely Pulmonary Rehabilitation plus Inspiratory Muscle Training Group (IMT+PR) or Pulmonary Rehabilitation Group (PR) using a numbered series of 34 prefilled envelops specifying group assignment generated by a computer-based program.
All patients underwent supervised PR program on 2 days per week for 3 months. Apart from that, they were asked to perform the home exercise program which was scheduled as 3 days per week and fill out the exercise follow-up form. The study group was provided with IMT in addition to the standard program.
Statistical analysis was conducted using SPSS (version 15, USA). The Shapiro-Wilk statistic was used to test the normality of the distribution of all variables. Nonparametric tests were used in comparison, because the number of samples and the standard deviations of in-group chance (∆) were very large. The Wilcoxon Signed Rank Test was used to compare the pre- and post-treatment data of the groups, and the Mann-Whitney U test was used in the group-wise comparison. Nonparametric variables were expressed as median (minimum-maximum), and descriptive variables as percent. The chi-square test was used for categorical variables. Significance level was accepted as p <0.05 in all tests. We estimated that a sample size of 19 patients for each group to have 80% power with 5% type 1 error level to detect a minimum clinically significant differences of 54 meters of the 6-min walk test with the highest standard deviation of the study parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant, Inspiratory Muscle Training
Keywords
rehabilitation, exercise, maximal inspiratory pressure, 6-minute walk test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMT+PR Group
Arm Type
Experimental
Arm Description
Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training. In addition standard pulmonary rehabilitation, patients received inspiratory muscle training.
Arm Title
PR group
Arm Type
Experimental
Arm Description
Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training.
Intervention Type
Other
Intervention Name(s)
inspiratory muscle training
Intervention Description
Inspiratory Muscle Training was performed with an exercise tool (Powerbreath®) with a resistance range of 0-90. The training intensity was started with 30% of the Maximum Inspiratory Pressure (MIP) value obtained as a result of the mouth pressure measurement16, training was progressively increased from 30% to 60% considering that they were terminal-stage pulmonary disease patients. Patients were asked to perform IMT for 15 minutes, twice a day, 7 days a week, for 3 months.
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
Aerobic training:The aerobic exercise program consists of treadmill walking, cycle ergometer and arm ergometer training. Group exercises were performed in sets of 15 minutes each with three exercise modalities.
Strength training:It is recommended that resistance targets are set at loads equivalent to 20 to 40% of a 1-repetition maximum (1RM) maneuver and performed between 8 to 12 repetitions for 1 to 2 sets per session.
Home exercise programme:The program included breathing exercises (local expansion exercises, diaphragmatic breathing and pursed lip breathing), free walking, upper and lower extremity strengthening exercises with Thera-Band
Primary Outcome Measure Information:
Title
Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months
Description
The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.
Time Frame
Three months
Title
Change from baseline Maximum Expiratory Pressure (MEP) at 3-months
Description
The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.
Time Frame
Three months
Title
Change from baseline distance covered in six minute walking test at 3-months
Description
The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk. Before and after the test, oxygen saturation, heart rate, Borg fatigue rating, and walking distance were recorded.
Time Frame
Three months
Title
Change from baseline Modified Medical Research Council (mMRC) Dyspnea Scale score at 3-months
Description
Dyspnea perceptions during the activities of daily living were assessed with modified Medical Research Council (mMRC) scale.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Change from baseline Forced Vital Capacity (FVC) at 3-months
Description
It was conducted by using the Sensor Medics model 2400 (Yorba Linda, CA, USA), and according to the American Thoracic Society (ATS) guidelines
Time Frame
Three months
Title
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months
Description
It was conducted by using the Sensor Medics model 2400 (Yorba Linda, CA, USA), and according to the American Thoracic Society (ATS) guidelines
Time Frame
Three months
Title
Change from baseline alveolar volume ratio of carbonmonoxide diffusion capacity (DLCO/VA) at 3-months
Description
It was performed in the pulmonary function test laboratory using Cosmed Quark PFT (USA) with single breath technique
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a diagnosis of terminally severe lung disease,
being listed for lung transplantation,
medically stable,
had no orthopedic or cardiac problems that would prevent them from exercising
had no transfer problem to the PR centre.
Exclusion Criteria:
Malignancy in the last 2 years,
Other advanced major organ / system dysfunction that can not be treated outside the lung,
Untreated non-pulmonary infection,
Disputed medical treatment discontinuity,
Untreatable psychiatric illness or psychosocial condition that interferes with treatment compliance,
No appropriate, reliable social support,
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of IMT on Exercise Capacity, Dyspnea and Lung Functions in LTx
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