The Effects of IMT on Exercise Capacity, Dyspnea and Lung Functions in LTx
- Conditions
- Inspiratory Muscle TrainingLung Transplant
- Interventions
- Other: inspiratory muscle trainingOther: Pulmonary rehabilitation
- Registration Number
- NCT03505697
- Lead Sponsor
- Istanbul Medipol University Hospital
- 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:
1. to examine the effect of respiratory muscle training on exercise capacity in lung transplantation candidates,
2. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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.
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description IMT+PR Group inspiratory muscle training 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. PR group Pulmonary rehabilitation Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training. IMT+PR Group Pulmonary rehabilitation 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.
- Primary Outcome Measures
Name Time Method Change from baseline Maximum Expiratory Pressure (MEP) at 3-months Three 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 Inspiratory Pressure (MIP) at 3-months Three 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 Three 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 Three months Dyspnea perceptions during the activities of daily living were assessed with modified Medical Research Council (mMRC) scale.
- Secondary Outcome Measures
Name Time Method Change from baseline alveolar volume ratio of carbonmonoxide diffusion capacity (DLCO/VA) at 3-months Three months It was performed in the pulmonary function test laboratory using Cosmed Quark PFT (USA) with single breath technique
Change from baseline Forced Vital Capacity (FVC) at 3-months Three 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 Three months It was conducted by using the Sensor Medics model 2400 (Yorba Linda, CA, USA), and according to the American Thoracic Society (ATS) guidelines