Lung Transplant RecipientsNCT05271019
Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients
A study testing Threshold load device in people with Lung Transplant Recipients and Muscle Weakness, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
Lung transplantation is an effective therapeutic option in the end-stage of chronic respiratory diseases. Lung transplantation improves lung function in terms of capacity and volume. However, the transplanted patient still suffers from muscle weakness and exercise intolerance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Transplant Recipients, Muscle Weakness, Respiratory Insufficiency
- What is being tested?
- Threshold load device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 4 Feb 2022to 15 Jan 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alert or able to cooperate with treatment.
- Able to give Informed Consent and sign it.
- Haemodynamically stable clinical situation or requiring minimal ventilatory support.
Who cannot join
- Detection of complete paralysis of the diaphragm.
- Progressive neuromuscular diseases or with spinal cord injury.
- Lack of collaboration or cooperation, or non-alertness (Glasgow ≤8).
- Unstable clinical situation (patients requiring high levels of ventilatory support (e.g., Positive End Expiratory Pressure (PEEP)> 10 cmH2O, Fraction Pressure of Inspired Oxygen (FiO2)> 0.60, nitric oxide, nebulised prostacyclin, high frequency oscillation).
- Clinical situation compromising the patient's recovery (cardiac arrhythmias, acute sepsis).
- When the medical treatment team and/or physiotherapy consider that there may be risks.
Show all 10Show fewer
- Severe pain or dyspnoea that interferes with or impedes the ability to breathe (e.g. rib fracture).
- Patients with lung retransplantation.
- Heart and lung transplant patients.
- When the patient is on palliative treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Early Inspiratory Muscle Training Combined With the Conventional Rehabilitation Programme in Lung Transplanted Patients
Lung transplantation is an effective therapeutic option in the end-stage of chronic respiratory diseases. Lung transplantation improves lung function in terms of capacity and volume. However, the transplanted patient still suffers from muscle weakness and exercise intolerance.
In recent years, respiratory physiotherapy work has intensified in critically ill patients with respiratory muscle weakness and the application of inspiratory muscle training (IMT), which has been shown in several studies to increase inspiratory muscle strength (IMT), improve ventilation and reduce the sensation of shortness of breath. Despite this emerging evidence, inspiratory muscle training (IMT) is not standard practice in most ICUs around the world, nor is it included in a protocolised manner among the components of a pulmonary rehabilitation programme.
Read more
Given the limited evidence, the investigators propose to conduct this randomised controlled clinical trial in lung transplant recipients.
The study will compare two groups of transplanted patients, a control group that will follow the rehabilitation programme and standard medical care and another experimental group that will also perform inspiratory muscle training.
This study aims to analyse the effect of IMT on inspiratory muscle strength, exercise capacity and quality of life in lung transplant patients.
Read the detailed description
For many years, lung transplantation has become an effective therapeutic option for end-stage chronic lung diseases. With transplantation, an improvement in lung function is achieved, achieving volumes and capacities close to those predicted.
After transplantation, muscle deterioration and exercise intolerance are still present; and it will take, according to studies, between 6 months to 1 year to achieve recovery to near normal values. Even in some cases, such as patients with a longer stay in the critical care unit who present a greater deterioration, these values do not reach normal values. In lung transplant recipients, pulmonary rehabilitation including aerobic exercise, resistance exercise and respiratory physiotherapy is the most effective strategy to improve exercise capacity and muscle strength.
Some clinical trials on inspiratory muscle training have identified favourable effects on respiratory muscle fitness and strength.
The purpose of this study is to analyse the impact of early training in lung transplant patients on respiratory muscle strength, exercise tolerance and quality of life. To this end, a randomised controlled trial will be carried out including lung transplant patients (single or double lung adults over 18 years of age) admitted to the hospital where a control group will perform the standard rehabilitation programme: respiratory, aerobic and upper and lower limb strength exercises; while the experimental group will be given inspiratory muscle training with a load of at least 30% of the maximum inspiratory pressure (MIP) in an early manner. Both groups will start the treatment in the critical care unit under conditions of clinical stability (haemodynamic, respiratory and neurologic) and will continue it in hospitalisation. Treatment is performed once a day, 5 days a week from Monday to Friday supervised by a trained physiotherapist.
Every 15 days a data collection will be performed to monitor the follow-up and the data collection will end 3 months after the lung transplantation.
The data collected will be compared from the start of treatment (pre- and post-transplant measurements) and will be compared between the groups.
- Conditions
- Lung Transplant Recipients, Muscle Weakness, Respiratory Insufficiency, Pulmonary Rehabilitation, Chronic Lung Disease
- Being tested
- Threshold load device
- Keywords
- respiratory muscle training, post lung transplant, breathing exercises, respiratory exercises, pulmonary rehabilitation, exercise capacity
- Medical subject headings
- Muscle Weakness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold load deviceDevice
Inspiratory Muscle Training (IMT) for 3 months:
Though a threshold loading device (5 sets of 6 repetitions, 1session/day, 5 days/week). the inspiratory load will start at 30% of MIP, or up to the maximum patient-tolerable load (max 60% of MIP), no more than 3-5/10 on the modified Borg scale.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Conventional Rehabilitation Program | No intervention | Standard rehabilitation program for 3 months, starting in the early phase in the ICU. A daily session from monday to friday. It includes breathing and secretions management exercises, building upper and lower extremity range of motion. Exercise progression should gradually incorporate aerobic exercises (treadmill, cycloergometer and upper and lower limb strength exercises) and limb strength training. Aerobic exercise at moderate intensity (no more than 3-4/10 on the modified Borg scale). Aerobic exercise starting with 20 minutes and gradually increasing up to 30 minutes. Limb strength training from 1 to 3 sets of 8-10 repetitions at moderate intensity. |
| Experimental group: Conventional Rehabilitation Program + Inspiratory Muscle Training (IMT) | Experimental | Standard rehabilitation program for 3 months, starting in the early phase in the ICU. A daily session from monday to friday. It includes breathing and secretions management exercises, building upper and lower extremity range of motion. Exercise progression should gradually incorporate aerobic exercises (treadmill, cycloergometer and upper and lower limb strength exercises) and limb strength training.
Aerobic exercise at moderate intensity (no more than 3-4/10 on the modified Borg scale). Aerobic exercise starting with 20 minutes and gradually increasing up to 30 minutes.
Limb strength training from 1 to 3 sets of 8-10 repetitions at moderate intensity. Receives: Device: Threshold load device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured in water centimeters (cmH2O).
Maximum respiratory pressure will be measure using a Respiratory Pressure Meter (RPM) named Micro-RPM® . Ever since Black and Hyatt (1969) reported this technique, it is used in healthy control subjects across all ages and athletes. Pressure is recorded at the mouth during quasi-static short (few seconds) maximal breathing according to American Thoracic Society (ATS) guidelines.The maximum value will be obtained. Am J respi Crit Care Med 2002;166:531-535.
Measured: The groups will be assessed at six times:Pre -Lung transplantation (Pre-LT), at baseline, every 15 days and 3 months after LT
Change in functional capacity: 6 minutes walk test (6MWT) measured in meters
6MWT is a submaximal exercise test that entails measurement of distance walked during 6 minutes. The 6MWT provides information regarding functional capacity, response to therapy and prognosis. The test will be in line with American Thoracic Society (ATS) guidelines Statement Guidelines for the Six Minutes Walk Test. Am J respi Crit Care Med 2002;166(1):111-117
Measured: The groups will be assessed Pre-LT and 3 months after LT
Change in Quality of life related with Health(SF-36) measured with a score from 0 to100
The SF-36 consists of 36 topics that explore eight dimensions of health status: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health.The SF-36 was previously validated in chronic obstructive pulmonary disease (COPD) patients and has been used in patients before and after lung transplantation (LT). Respiration 2000;67:159-65. Chest 2000;118:408-16.
Measured: The groups will be assessed Pre-LT and 3 months after LT
Change in Respiratory mechanics parameters: respiratory work measured in Joules (J)
Respiratory mechanics parameters will be analyzed using a POWERbreathe electronic device: the work of breathing is the area for total external inspiratory work as integrated from mouth pressure (cmH2O) and volume (L) signals over time. Physical Therapy 2015;95(9):1264-1273
Measured: The groups will be assessed at baseline, every 15 days and 3 months after LT
Change in Inspiratory muscle endurance (Tlim) measure in seconds (s)
Inspiratory muscle endurance is the time the patient breathe against a submaximal inspiratory load provided by device (POWERbreathe) until task failure due to the symptom limitation. Physical Therapy 2015;95(9):1264-1273.
Measured: The groups will be assessed at baseline, every 15 days and 3 months after LT
Secondary outcomes (3)
Changes in dyspnea measured with the modified borg scale 0-10
Dyspnea perceptions during the activities of daily living and during exert were assessed. Med Sci Sports Exert 1982; 14: 377-81.
Measured: The groups will be assessed at baseline, every 15 days and 3 months after LT
Incidence of atelectasis measured with a score from 0 to 4
Registry of Atelectasis is a complete or partial collapse of the whole lung or a part (lobe) of the lung diagnosed by the responsible physician by Chest x-ray report or physician documentation of atelectasis.The postoperative chest radiographs were scored according the following rating (2): 0, no abnormalities; 1, minor atelectasis on one side; 2,minor atelectasis on both sides; 3,major atelectasis on one side; and 4, major atelectasis on both sides. Crit Care Med 2000;28:679-83. Physiotherapy 2011;97(4):278-283
Measured: The patients will be assessed through study completion, an average of 3 months
Change in Pulmonary Function measured with Spirometry Test. FEV1/FVC measured in %
the investigators will interpret the data obtained from forced spirometry to evaluate how our patient's pulmonary functions is developing after the surgery. FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).The result of this ratio is expressed as FEV1%. Spirometry is traditionally and widely used to measure pulmonary function and capacity. This test will be performed with a spirometer according to American Thoracic Society (ATS) guidelines and measured in liters . Am J respi Crit Care Med 2002;166:521-522, Eur respi J 2005; 26: 153-161.
Measured: The groups will be assessed Pre-LT, at baseline and 3 months after LT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start4 Feb 2022
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant RecipientsStudies 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
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Responsible party
- Principal investigator, Laura Muelas Gomez, Puerta de Hierro University Hospital
- Investigators
- Laura Muelas Gómez, PT, MSc, Principal investigator, Hospital Universitario Puerta de Hierro MajadahondaMaria de los Angeles Atín Arratibel, MD, PhD, Study director, Universidad Complutense de MadridMaria A Cebria i Iranzo, PT, PhD, Study director, Hospital Universitario y Politécnico La Fe,ValenciaIgnacio Latorre-Marco, DUE, Study chair, Hospital Universitario Puerta de Hierro MajadahondaMontserrat Solis Muñoz, DUE, PhD, Study chair, Hospital Universitario Puerta de Hierro MajadahondaAna Royuela Vicente, Phd, Study chair, Hospital Universitario Puerta de Hierro MajadahondaCristina Ruiz González, PT, Study chair, Hospital Universitario Puerta de Hierro MajadahondaSilvia Herguedas Cristobal, PT, Study chair, Hospital Universitario Puerta de Hierro Majadahonda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271019
- Sponsor's protocol ID
- PI 195/21
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2022
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For now I don't want to share information about the study until I have the protocol or some published results of the intervention. At that time, the information will be shared with the other researchers.
Publications
Pehlivan E, Mutluay F, Balci A, Kilic L. The effects of inspiratory muscle training on exercise capacity, dyspnea and respiratory functions in lung transplantation candidates: a randomized controlled trial. Clin Rehabil. 2018 Oct;32(10):1328-1339. doi: 10.1177/0269215518777560. Epub 2018 May 30.
PubMed 29843525Nissan Graur PW and MRK. Annals of Physiotherapy Clinics Effects of Inspiratory Muscle Training on Respiratory Muscle Strength , Functional Capacity and Health Related Quality of Life of Patients Following Lung Transplantation. Ann Physiother Clin. 2020;2(1):10-2.
Neumannova K, Kuzilkova V, Zurková M, Hubackova L, Michalcikova T, Jakubec P, et al. Respiratory muscle training improves the work of breathing and decreases inspiratory muscle fatigue in patients after lung transplantation. Eur Respir J. 2019 Sep 28;54(suppl 63)
Gosselink R, De Vos J, van den Heuvel SP, Segers J, Decramer M, Kwakkel G. Impact of inspiratory muscle training in patients with COPD: what is the evidence? Eur Respir J. 2011 Feb;37(2):416-25. doi: 10.1183/09031936.00031810.
PubMed 21282809Hoffman M, Augusto VM, Eduardo DS, Silveira BMF, Lemos MD, Parreira VF. Inspiratory muscle training reduces dyspnea during activities of daily living and improves inspiratory muscle function and quality of life in patients with advanced lung disease. Physiother Theory Pract. 2021 Aug;37(8):895-905. doi: 10.1080/09593985.2019.1656314. Epub 2019 Aug 20.
PubMed 31429627Kendall F, Oliveira J, Peleteiro B, Pinho P, Bastos PT. Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis. Disabil Rehabil. 2018 Apr;40(8):864-882. doi: 10.1080/09638288.2016.1277396. Epub 2017 Jan 17.
PubMed 28093920Langer D, Burtin C, Schepers L, Ivanova A, Verleden G, Decramer M, Troosters T, Gosselink R. Exercise training after lung transplantation improves participation in daily activity: a randomized controlled trial. Am J Transplant. 2012 Jun;12(6):1584-92. doi: 10.1111/j.1600-6143.2012.04000.x. Epub 2012 Mar 5.
PubMed 22390625Candemir I, Ergun P, Kaymaz D, Demir N, Tasdemir F, Sengul F, Egesel N, Yekeler E. The Efficacy of Outpatient Pulmonary Rehabilitation After Bilateral Lung Transplantation. J Cardiopulm Rehabil Prev. 2019 Jul;39(4):E7-E12. doi: 10.1097/HCR.0000000000000391.
PubMed 31241521Yamaga T, Yamamoto S, Sakai Y, Ichiyama T. Effects of inspiratory muscle training after lung transplantation in children. BMJ Case Rep. 2021 Jul 21;14(7):e241114. doi: 10.1136/bcr-2020-241114.
PubMed 34290002Langer D, Gosselink R, Pitta F, Burtin C, Verleden G, Dupont L, Decramer M, Troosters T. Physical activity in daily life 1 year after lung transplantation. J Heart Lung Transplant. 2009 Jun;28(6):572-8. doi: 10.1016/j.healun.2009.03.007. Epub 2009 May 5.
PubMed 19481017
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Inspiratory Muscle Training Combined With the Conventional Rehabilitation Programme in Lung Transplanted Patients
- ClinicalTrials.gov ID
- NCT05271019
- Acronym / sponsor ID
- PI 195/21
- Conditions
- Lung Transplant Recipients, Muscle Weakness, Respiratory Insufficiency, Pulmonary Rehabilitation, Chronic Lung Disease
- Keywords
- respiratory muscle training, post lung transplant, breathing exercises, respiratory exercises, pulmonary rehabilitation, exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 8 Mar 2022 (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.
Lung transplantation is an effective therapeutic option in the end-stage of chronic respiratory diseases. Lung transplantation improves lung function in terms of capacity and volume. However, the transplanted patient still suffers from muscle weakness and exercise intolerance.
In recent years, respiratory physiotherapy work has intensified in critically ill patients with respiratory muscle weakness and the application of inspiratory muscle training (IMT), which has been shown in several studies to increase inspiratory muscle strength (IMT), improve ventilation and reduce the sensation of shortness of breath. Despite this emerging evidence, inspiratory muscle training (IMT) is not standard practice in most ICUs around the world, nor is it included in a protocolised manner among the components of a pulmonary rehabilitation programme.
Given the limited evidence, the investigators propose to conduct this randomised controlled clinical trial in lung transplant recipients.
The study will compare two groups of transplanted patients, a control group that will follow the rehabilitation programme and standard medical care and another experimental group that will also perform inspiratory muscle training.
This study aims to analyse the effect of IMT on inspiratory muscle strength, exercise capacity and quality of life in lung transplant patients.
Detailed description
For many years, lung transplantation has become an effective therapeutic option for end-stage chronic lung diseases. With transplantation, an improvement in lung function is achieved, achieving volumes and capacities close to those predicted.
After transplantation, muscle deterioration and exercise intolerance are still present; and it will take, according to studies, between 6 months to 1 year to achieve recovery to near normal values. Even in some cases, such as patients with a longer stay in the critical care unit who present a greater deterioration, these values do not reach normal values. In lung transplant recipients, pulmonary rehabilitation including aerobic exercise, resistance exercise and respiratory physiotherapy is the most effective strategy to improve exercise capacity and muscle strength.
Some clinical trials on inspiratory muscle training have identified favourable effects on respiratory muscle fitness and strength.
The purpose of this study is to analyse the impact of early training in lung transplant patients on respiratory muscle strength, exercise tolerance and quality of life. To this end, a randomised controlled trial will be carried out including lung transplant patients (single or double lung adults over 18 years of age) admitted to the hospital where a control group will perform the standard rehabilitation programme: respiratory, aerobic and upper and lower limb strength exercises; while the experimental group will be given inspiratory muscle training with a load of at least 30% of the maximum inspiratory pressure (MIP) in an early manner. Both groups will start the treatment in the critical care unit under conditions of clinical stability (haemodynamic, respiratory and neurologic) and will continue it in hospitalisation. Treatment is performed once a day, 5 days a week from Monday to Friday supervised by a trained physiotherapist.
Every 15 days a data collection will be performed to monitor the follow-up and the data collection will end 3 months after the lung transplantation.
The data collected will be compared from the start of treatment (pre- and post-transplant measurements) and will be compared between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Control group: Conventional Rehabilitation Program | No intervention | –Standard rehabilitation program for 3 months, starting in the early phase in the ICU. A daily session from monday to friday. It includes breathing and secretions management exercises, building upper and lower extremity range of motion. Exercise progression should gradually incorporate aerobic exercises (treadmill, cycloergometer and upper and lower limb strength exercises) and limb strength training. Aerobic exercise at moderate intensity (no more than 3-4/10 on the modified Borg scale). Aerobic exercise starting with 20 minutes and gradually increasing up to 30 minutes. Limb strength training from 1 to 3 sets of 8-10 repetitions at moderate intensity. |
| Experimental group: Conventional Rehabilitation Program + Inspiratory Muscle Training (IMT) | Experimental | Device: Threshold load deviceStandard rehabilitation program for 3 months, starting in the early phase in the ICU. A daily session from monday to friday. It includes breathing and secretions management exercises, building upper and lower extremity range of motion. Exercise progression should gradually incorporate aerobic exercises (treadmill, cycloergometer and upper and lower limb strength exercises) and limb strength training. Aerobic exercise at moderate intensity (no more than 3-4/10 on the modified Borg scale). Aerobic exercise starting with 20 minutes and gradually increasing up to 30 minutes. Limb strength training from 1 to 3 sets of 8-10 repetitions at moderate intensity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Alert or able to cooperate with treatment.
- Able to give Informed Consent and sign it.
- Haemodynamically stable clinical situation or requiring minimal ventilatory support.
Key exclusion criteria (10 listed)
- Detection of complete paralysis of the diaphragm.
- Progressive neuromuscular diseases or with spinal cord injury.
- Lack of collaboration or cooperation, or non-alertness (Glasgow ≤8).
- Unstable clinical situation (patients requiring high levels of ventilatory support (e.g., Positive End Expiratory Pressure (PEEP)> 10 cmH2O, Fraction Pressure of Inspired Oxygen (FiO2)> 0.60, nitric oxide, nebulised prostacyclin, high frequency oscillation).
- Clinical situation compromising the patient's recovery (cardiac arrhythmias, acute sepsis).
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 |
|---|---|---|
| Threshold load deviceInspiratory Muscle Training (IMT) for 3 months: Though a threshold loading device (5 sets of 6 repetitions, 1session/day, 5 days/week). the inspiratory load will start at 30% of MIP, or up to the maximum patient-tolerable load (max 60% of MIP), no more than 3-5/10 on the modified Borg scale. | Device | Experimental group: Conventional Rehabilitation Program + Inspiratory Muscle Training (IMT) |
Primary outcome
Change in respiratory strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured in water centimeters (cmH2O).
Time frame: The groups will be assessed at six times:Pre -Lung transplantation (Pre-LT), at baseline, every 15 days and 3 months after LT
Maximum respiratory pressure will be measure using a Respiratory Pressure Meter (RPM) named Micro-RPM® . Ever since Black and Hyatt (1969) reported this technique, it is used in healthy control subjects across all ages and athletes. Pressure is recorded at the mouth during quasi-static short (few seconds) maximal breathing according to American Thoracic Society (ATS) guidelines.The maximum value will be obtained. Am J respi Crit Care Med 2002;166:531-535.
Change in functional capacity: 6 minutes walk test (6MWT) measured in meters
Time frame: The groups will be assessed Pre-LT and 3 months after LT
6MWT is a submaximal exercise test that entails measurement of distance walked during 6 minutes. The 6MWT provides information regarding functional capacity, response to therapy and prognosis. The test will be in line with American Thoracic Society (ATS) guidelines Statement Guidelines for the Six Minutes Walk Test. Am J respi Crit Care Med 2002;166(1):111-117
Change in Quality of life related with Health(SF-36) measured with a score from 0 to100
Time frame: The groups will be assessed Pre-LT and 3 months after LT
The SF-36 consists of 36 topics that explore eight dimensions of health status: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health.The SF-36 was previously validated in chronic obstructive pulmonary disease (COPD) patients and has been used in patients before and after lung transplantation (LT). Respiration 2000;67:159-65. Chest 2000;118:408-16.
Change in Respiratory mechanics parameters: respiratory work measured in Joules (J)
Time frame: The groups will be assessed at baseline, every 15 days and 3 months after LT
Respiratory mechanics parameters will be analyzed using a POWERbreathe electronic device: the work of breathing is the area for total external inspiratory work as integrated from mouth pressure (cmH2O) and volume (L) signals over time. Physical Therapy 2015;95(9):1264-1273
Change in Inspiratory muscle endurance (Tlim) measure in seconds (s)
Time frame: The groups will be assessed at baseline, every 15 days and 3 months after LT
Inspiratory muscle endurance is the time the patient breathe against a submaximal inspiratory load provided by device (POWERbreathe) until task failure due to the symptom limitation. Physical Therapy 2015;95(9):1264-1273.
3 secondary outcomes
Changes in dyspnea measured with the modified borg scale 0-10
Time frame: The groups will be assessed at baseline, every 15 days and 3 months after LT
Incidence of atelectasis measured with a score from 0 to 4
Time frame: The patients will be assessed through study completion, an average of 3 months
Change in Pulmonary Function measured with Spirometry Test. FEV1/FVC measured in %
Time frame: The groups will be assessed Pre-LT, at baseline and 3 months after LT
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 Sep 2026.
- Background: PubMed 29843525Pehlivan E, Mutluay F, Balci A, Kilic L. The effects of inspiratory muscle training on exercise capacity, dyspnea and respiratory functions in lung transplantation candidates: a randomized controlled trial. Clin Rehabil. 2018 Oct;32(10):1328-1339. doi: 10.1177/0269215518777560. Epub 2018 May 30.
- BackgroundNissan Graur PW and MRK. Annals of Physiotherapy Clinics Effects of Inspiratory Muscle Training on Respiratory Muscle Strength , Functional Capacity and Health Related Quality of Life of Patients Following Lung Transplantation. Ann Physiother Clin. 2020;2(1):10-2.
- BackgroundNeumannova K, Kuzilkova V, Zurková M, Hubackova L, Michalcikova T, Jakubec P, et al. Respiratory muscle training improves the work of breathing and decreases inspiratory muscle fatigue in patients after lung transplantation. Eur Respir J. 2019 Sep 28;54(suppl 63)
- Background: PubMed 21282809Gosselink R, De Vos J, van den Heuvel SP, Segers J, Decramer M, Kwakkel G. Impact of inspiratory muscle training in patients with COPD: what is the evidence? Eur Respir J. 2011 Feb;37(2):416-25. doi: 10.1183/09031936.00031810.
- Background: PubMed 31429627Hoffman M, Augusto VM, Eduardo DS, Silveira BMF, Lemos MD, Parreira VF. Inspiratory muscle training reduces dyspnea during activities of daily living and improves inspiratory muscle function and quality of life in patients with advanced lung disease. Physiother Theory Pract. 2021 Aug;37(8):895-905. doi: 10.1080/09593985.2019.1656314. Epub 2019 Aug 20.
- Background: PubMed 28093920Kendall F, Oliveira J, Peleteiro B, Pinho P, Bastos PT. Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis. Disabil Rehabil. 2018 Apr;40(8):864-882. doi: 10.1080/09638288.2016.1277396. Epub 2017 Jan 17.
- Background: PubMed 22390625Langer D, Burtin C, Schepers L, Ivanova A, Verleden G, Decramer M, Troosters T, Gosselink R. Exercise training after lung transplantation improves participation in daily activity: a randomized controlled trial. Am J Transplant. 2012 Jun;12(6):1584-92. doi: 10.1111/j.1600-6143.2012.04000.x. Epub 2012 Mar 5.
- Background: PubMed 31241521Candemir I, Ergun P, Kaymaz D, Demir N, Tasdemir F, Sengul F, Egesel N, Yekeler E. The Efficacy of Outpatient Pulmonary Rehabilitation After Bilateral Lung Transplantation. J Cardiopulm Rehabil Prev. 2019 Jul;39(4):E7-E12. doi: 10.1097/HCR.0000000000000391.
- Background: PubMed 34290002Yamaga T, Yamamoto S, Sakai Y, Ichiyama T. Effects of inspiratory muscle training after lung transplantation in children. BMJ Case Rep. 2021 Jul 21;14(7):e241114. doi: 10.1136/bcr-2020-241114.
- Background: PubMed 19481017Langer D, Gosselink R, Pitta F, Burtin C, Verleden G, Dupont L, Decramer M, Troosters T. Physical activity in daily life 1 year after lung transplantation. J Heart Lung Transplant. 2009 Jun;28(6):572-8. doi: 10.1016/j.healun.2009.03.007. Epub 2009 May 5.
- Individual participant dataSharing planned: No. For now I don't want to share information about the study until I have the protocol or some published results of the intervention. At that time, the information will be shared with the other researchers.
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Active, not recruitingPhase 3
RSV Vaccine in Transplant Recipients
Vaccine Response Impaired, Respiratory Syncytial Virus Infections
RecruitingPhase 4
Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
Vaccination, Respiratory Syncytial Virus (RSV)
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
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.
Laura Muelas Gómez, PT, MSc principal investigator
Hospital Universitario Puerta de Hierro Majadahonda
Maria de los Angeles Atín Arratibel, MD, PhD study director
Universidad Complutense de Madrid
Maria A Cebria i Iranzo, PT, PhD study director
Hospital Universitario y Politécnico La Fe,Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold load device in people with Lung Transplant Recipients and Muscle Weakness, run by Puerta de Hierro University Hospital at 1 site in Spain.
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 3 inclusion and 10 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 in respiratory strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured in water centimeters (cmH2O). (time frame: The groups will be assessed at six times:Pre -Lung transplantation (Pre-LT), at baseline, every 15 days and 3 months after LT). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05271019, which also lists 10 linked publications.
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 Sep 2026.