Lung TransplantNCT03505697
The Effects of IMT on Exercise Capacity, Dyspnea and Lung Functions in LTx
A study testing inspiratory muscle training and Pulmonary rehabilitation in people with Lung Transplant and Inspiratory Muscle Training, run by Istanbul Medipol University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Transplant, Inspiratory Muscle Training
- What is being tested?
- inspiratory muscle training and Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
About this study
Official title: The Effects of Inspiratory Muscle Training on Exercise Capacity, Dyspnea and Lung Functions in Lung Transplantation Candidates
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.
Read the 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.
- Conditions
- Lung Transplant, Inspiratory Muscle Training
- Being tested
- inspiratory muscle training, Pulmonary rehabilitation
- Keywords
- rehabilitation, exercise, maximal inspiratory pressure, 6-minute walk test
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
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.
Pulmonary rehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| IMT+PR Group | Experimental | 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. Receives: Other: inspiratory muscle training; Other: Pulmonary rehabilitation |
| PR group | Experimental | Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training. Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
Secondary outcomes (3)
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
Measured: Three months
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
Measured: Three months
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
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Apr 2016
- Primary completion1 Mar 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505697
- Sponsor's protocol ID
- esrapehlivan
- Status last verified
- Apr 2018
- First submitted
- 7 Apr 2018
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inspiratory Muscle Training on Exercise Capacity, Dyspnea and Lung Functions in Lung Transplantation Candidates
- ClinicalTrials.gov ID
- NCT03505697
- Acronym / sponsor ID
- esrapehlivan
- Conditions
- Lung Transplant, Inspiratory Muscle Training
- Keywords
- rehabilitation, exercise, maximal inspiratory pressure, 6-minute walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT+PR Group | Experimental | Other: inspiratory muscle training, Other: Pulmonary rehabilitationPatients 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 | Experimental | Other: Pulmonary rehabilitationPatients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle trainingInspiratory 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. | Other | IMT+PR Group |
| Pulmonary rehabilitationAerobic 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 | Other | IMT+PR Group, PR group |
Primary outcome
Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months
Time frame: 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 Expiratory Pressure (MEP) at 3-months
Time frame: 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
Time frame: 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
Time frame: Three months
Dyspnea perceptions during the activities of daily living were assessed with modified Medical Research Council (mMRC) scale.
3 secondary outcomes
Change from baseline Forced Vital Capacity (FVC) at 3-months
Time frame: Three months
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months
Time frame: Three months
Change from baseline alveolar volume ratio of carbonmonoxide diffusion capacity (DLCO/VA) at 3-months
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training and Pulmonary rehabilitation in people with Lung Transplant and Inspiratory Muscle Training, run by Istanbul Medipol University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months (time frame: Three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.