Lung TransplantNCT04244734
Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.
A study testing New Treatment Protocol-MotoMED® in people with Lung Transplant and Rehabilitation, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Introduction: Following pulmonary transplantation (PT), peripheral and respiratory muscle weakness, and associated global malfunction are some of the limiting factors in rapid recovery. Effective early implantation pulmonary rehabilitation programs are currently lacking. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplant, Rehabilitation
- What is being tested?
- New Treatment Protocol-MotoMED®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- 23 May 2019to Aug 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral lung transplantation.
- Age criteria (From 18 to 70 years old).
- Start the rehabilitation program between the first 15 days after lung transplantation.
Who cannot join
- Do not meet inclusion criteria.
- Fulfill some criterion of absolute contraindication for the use of electrostimulation in the lower extremities (pacemaker, pregnancy or unstable fracture that requires absolute rest and immobilization.
- Cognitive or psychiatric alteration that does not allow you to participate in the project.
- Not wanting to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Vall d'Hebron Research Institute
Barcelona, 08035
About this study
Introduction: Following pulmonary transplantation (PT), peripheral and respiratory muscle weakness, and associated global malfunction are some of the limiting factors in rapid recovery. Effective early implantation pulmonary rehabilitation programs are currently lacking.
Objectives: To introduce an early rehabilitation program in the ICU after PT to see if there is an improvement in functionality, an increase in strength and muscle mass, an improvement in the strength of the respiratory muscles and a shorter hospitalization time in the ICU and in the ward.
Read more
Methodology: A single-blind randomized clinical trial will be performed to divide patients with PT into one experimental group and another control group. Prior to the PT, those patients between the ages of 18 and 70 will be recruited, to be admitted to the ICU of Vall Hebron University Hospital, and who have been prescribed pulmonary rehabilitation with onset in the first 15 days after the surgery. The control group receives regular treatment in the ICU, which includes muscle strengthening exercises, passive/assisted or active mobilizations, and respiratory physiotherapy with breathing muscle strengthening in a medium load. The experimental group receives a new early rehabilitation program based on a patient's in-bed cycling that allows controlled and adapted training to the patient's situation, along with coordinated exercise with neuromuscular electrostimulation and respiratory physiotherapy with breathing muscle strengthening in a high load. Improvement will be observed through functional scales (6MWT), muscle dynamometry, manual muscle test (MRC-SumScore), bioimpedanciometry, inspiratory and maximal expiratory pressures, spirometry, frailty and sarcopenia tests and a long-term Cardiopulmonary Exercise Testing.
Expected Outcomes: Patients who perform the experimental group are expected to have an early discharge from the ICU and a reduction of the total hospital admission. Is also expected that the experimental group will improve the functional capacity and muscular strength, and they will have a lower risk of fragility in long term. It is also expected that the patients in the experimental group will soon be able to normalize their oxygen consumption a year after lung transplantation.
- Conditions
- Lung Transplant, Rehabilitation
- Being tested
- Usual care treatment, New Treatment Protocol-MotoMED®
- Keywords
- lung transplantation, rehabilitation, respiratory muscle training, early mobilisation, Neuromuscular electrostimulation, in-bed cycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care treatmentOther
Also called usual care
All evaluations are the same in both groups:
Baseline evaluation
ICU admission (If patient hemodynamically stable initiates physiotherapy treatment within the first 15 days after surgery).
Treatment:A daily session from Monday to Friday of 40 minutes according to patient functional status: Passive or active-assisted or active mobilizations, muscle enhancement, respiratory physiotherapy and inspiratory muscle training at 40% of the PIM value.
2nd evaluation when patient has a RASS -1/0 score: 3rd evaluation when ICU discharge.
Treatment ward: A 60-minute daily session according to patient functional status in the gym (physiotherapy area in hospital): Cycloergometer, muscle enhancement, respiratory physiotherapy and inspiratory muscle training.
4th evaluation when hospital discharge 5th evaluation (1 month after discharge) 6th evaluation (4 months after discharge) 7th evaluation (1 year after surgery)
New Treatment Protocol-MotoMED®Other
Also called MotoMED + NEMS
Baseline evaluation
ICU admission (If patient hemodynamically stable initiates physiotherapy treatment within the first 15 days after surgery).
Treatment: A daily session from Monday to Friday of 40 minutes (5 minutes of warm-up, 30 of training and 5 of cooling). Combined quadriceps / biceps femoris electrotherapy: at 200-350μs intensity. Respiratory physiotherapy with the objectives: Airway permeabilization and inspiratory muscle training at 60% of the PIM value.
2nd evaluation when patient has a RASS -1/0 score: 3rd evaluation when ICU discharge.
Treatment ward: A 60-minute daily session according to patient functional status in the gym (physiotherapy area in hospital): Cycloergometer, muscle enhancement, respiratory physiotherapy and inspiratory muscle training.
4th evaluation when hospital discharge 5th evaluation (1 month after discharge) 6th evaluation (4 months after discharge) 7th evaluation (1 year after surgery)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | The control group receives regular treatment in the ICU, which includes muscle strengthening exercises, passive/assisted or active mobilizations, and respiratory physiotherapy with breathing muscle strengthening in a medium load (initially at 40% load from results in MIP). Receives: Other: Usual care treatment |
| Group 2 | Experimental | The experimental group receives a new early rehabilitation program based on a patient's in-bed cycling that allows controlled and adapted training to the patient's situation, along with coordinated exercise with neuromuscular electrostimulation and respiratory physiotherapy with breathing muscle strengthening in a high load (initially at 60% load from results in MIP). Receives: Other: New Treatment Protocol-MotoMED® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Measured with 6MWT
It will be measured in different moments:
Baseline Hospital discharge After 1 month of discharge After 4 month of discharge
1 year after the discharge
Measured: Through study completion, an average of 1 year
Muscle strength
Measured with dynamometer
It will be measured in different moments
Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge
1 year after the discharge
Measured: Through study completion, an average of 1 year
Muscle mass
Measured with bioimpedanciometry
It will be measured in different moments:
Baseline Hospital discharge After 1 month of discharge After 4 month of discharge
1 year after the discharge
Measured: Through study completion, an average of 1 year
Respiratory muscle strength
Measured with MIP and MEP
It will be measured in different moments
Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge
1 year after the discharge
Measured: Through study completion, an average of 1 year
Cough strength
Measured with Peak Cough Flow
It will be measured in different moments
Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge
1 year after the discharge
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Frailty
Measured with the short physical performance battery test (SPPB test)
SPPB (maximum 12 points)
- 7 points or less: Frailty
- 8 to 9 points: Pre-frailty
- More than 10 points: Not frailty
It will be measured in different moments:
Baseline Hospital discharge After 1 month of discharge After 4 month of discharge
1 year after the discharge
Measured: Through study completion, an average of 1 year
Muscle balance
Measured with the Medical Research Council sum score test
It will be measured in different moments
Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge
1 year after the discharge
Measured: Through study completion, an average of 1 year
Pulmonary Capacity
Measured with a spirometer
We will interpret the data obtained from forced spirometry to evaluate how our patient's pulmonary functions is developing after the surgery.
Data collection:
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%.
The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
It will be measured in different moments Baseline
1 year after the discharge
Measured: Through study completion, an average of 1 year
Oxygen consumption
Measured with the Cardiopulmonary effort test
It will be measured in different moments
After 1 month of discharge After 4 month of discharge
1 year after the discharge
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start23 May 2019
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Responsible party
- Sponsor
- Investigators
- Bernat Planas Pascual, PT, MSc, Principal investigator, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244734
- Sponsor's protocol ID
- PR(AG)49-2019
- Status last verified
- Nov 2020
- First submitted
- 17 Jan 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, King TE Jr, Lancaster L, Noble PW, Sahn SA, Thomeer M, Valeyre D, Wells AU. Forced vital capacity in patients with idiopathic pulmonary fibrosis: test properties and minimal clinically important difference. Am J Respir Crit Care Med. 2011 Dec 15;184(12):1382-9. doi: 10.1164/rccm.201105-0840OC. Epub 2011 Sep 22.
PubMed 21940789Roman A, Ussetti P, Sole A, Zurbano F, Borro JM, Vaquero JM, de Pablo A, Morales P, Blanco M, Bravo C, Cifrian J, de la Torre M, Gamez P, Laporta R, Monforte V, Mons R, Salvatierra A, Santos F, Sole J, Varela A; Sociedad Espanola de Neumologia y Cirugia Toracica. Guidelines for the selection of lung transplantation candidates. Arch Bronconeumol. 2011 Jun;47(6):303-9. doi: 10.1016/j.arbres.2011.03.007. Epub 2011 May 4. English, Spanish.
PubMed 21536362Coll E, Santos F, Ussetti P, Canela M, Borro JM, De La Torre M, Varela A, Zurbano F, Mons R, Morales P, Pastor J, Salvatierra A, de Pablo A, Gamez P, Moreno A, Sole J, Roman A. The Spanish Lung Transplant Registry: first report of results (2006-2010). Arch Bronconeumol. 2013 Feb;49(2):70-8. doi: 10.1016/j.arbres.2012.06.001. Epub 2012 Aug 28. English, Spanish.
PubMed 22939738Weill D, Benden C, Corris PA, Dark JH, Davis RD, Keshavjee S, Lederer DJ, Mulligan MJ, Patterson GA, Singer LG, Snell GI, Verleden GM, Zamora MR, Glanville AR. A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2015 Jan;34(1):1-15. doi: 10.1016/j.healun.2014.06.014. Epub 2014 Jun 26.
PubMed 25085497Weill D. Lung transplantation: indications and contraindications. J Thorac Dis. 2018 Jul;10(7):4574-4587. doi: 10.21037/jtd.2018.06.141.
PubMed 30174910Shigemura N, Bhama J, Gries CJ, Kawamura T, Crespo M, Johnson B, Zaldonis D, Pilewski J, Toyoda Y, Bermudez C. Lung transplantation in patients with prior cardiothoracic surgical procedures. Am J Transplant. 2012 May;12(5):1249-55. doi: 10.1111/j.1600-6143.2011.03946.x. Epub 2012 Feb 2.
PubMed 22300103Reynaud-Gaubert M, Mornex JF, Mal H, Treilhaud M, Dromer C, Quetant S, Leroy-Ladurie F, Guillemain R, Philit F, Dauriat G, Grenet D, Stern M. Lung transplantation for lymphangioleiomyomatosis: the French experience. Transplantation. 2008 Aug 27;86(4):515-20. doi: 10.1097/TP.0b013e31817c15df.
PubMed 18724219Detterbeck FC, Egan TM, Mill MR. Lung transplantation after previous thoracic surgical procedures. Ann Thorac Surg. 1995 Jul;60(1):139-43.
PubMed 7598576Curtis HJ, Bourke SJ, Dark JH, Corris PA. Lung transplantation outcome in cystic fibrosis patients with previous pneumothorax. J Heart Lung Transplant. 2005 Jul;24(7):865-9. doi: 10.1016/j.healun.2004.05.024.
PubMed 15982615American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):646-64. doi: 10.1164/ajrccm.161.2.ats3-00. No abstract available.
PubMed 10673212Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
PubMed 21471066du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, Lancaster L, Noble PW, Raghu G, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, King TE Jr. Ascertainment of individual risk of mortality for patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Aug 15;184(4):459-66. doi: 10.1164/rccm.201011-1790OC.
PubMed 21616999de Gracia J, Mata F, Alvarez A, Casals T, Gatner S, Vendrell M, de la Rosa D, Guarner L, Hermosilla E. Genotype-phenotype correlation for pulmonary function in cystic fibrosis. Thorax. 2005 Jul;60(7):558-63. doi: 10.1136/thx.2004.031153.
PubMed 15994263De Soyza A, Archer L, Wardle J, Parry G, Dark JH, Gould K, Corris PA. Pulmonary transplantation for cystic fibrosis: pre-transplant recipient characteristics in patients dying of peri-operative sepsis. J Heart Lung Transplant. 2003 Jul;22(7):764-9. doi: 10.1016/s1053-2498(02)00641-1.
PubMed 12873544Rosenbluth DB, Wilson K, Ferkol T, Schuster DP. Lung function decline in cystic fibrosis patients and timing for lung transplantation referral. Chest. 2004 Aug;126(2):412-9. doi: 10.1378/chest.126.2.412.
PubMed 15302726
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.
- ClinicalTrials.gov ID
- NCT04244734
- Acronym / sponsor ID
- PR(AG)49-2019
- Conditions
- Lung Transplant, Rehabilitation
- Keywords
- lung transplantation, rehabilitation, respiratory muscle training, early mobilisation, Neuromuscular electrostimulation, in-bed cycling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Study start
- 23 May 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 28 Jan 2020 (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.
Introduction: Following pulmonary transplantation (PT), peripheral and respiratory muscle weakness, and associated global malfunction are some of the limiting factors in rapid recovery. Effective early implantation pulmonary rehabilitation programs are currently lacking.
Objectives: To introduce an early rehabilitation program in the ICU after PT to see if there is an improvement in functionality, an increase in strength and muscle mass, an improvement in the strength of the respiratory muscles and a shorter hospitalization time in the ICU and in the ward.
Methodology: A single-blind randomized clinical trial will be performed to divide patients with PT into one experimental group and another control group. Prior to the PT, those patients between the ages of 18 and 70 will be recruited, to be admitted to the ICU of Vall Hebron University Hospital, and who have been prescribed pulmonary rehabilitation with onset in the first 15 days after the surgery. The control group receives regular treatment in the ICU, which includes muscle strengthening exercises, passive/assisted or active mobilizations, and respiratory physiotherapy with breathing muscle strengthening in a medium load. The experimental group receives a new early rehabilitation program based on a patient's in-bed cycling that allows controlled and adapted training to the patient's situation, along with coordinated exercise with neuromuscular electrostimulation and respiratory physiotherapy with breathing muscle strengthening in a high load. Improvement will be observed through functional scales (6MWT), muscle dynamometry, manual muscle test (MRC-SumScore), bioimpedanciometry, inspiratory and maximal expiratory pressures, spirometry, frailty and sarcopenia tests and a long-term Cardiopulmonary Exercise Testing.
Expected Outcomes: Patients who perform the experimental group are expected to have an early discharge from the ICU and a reduction of the total hospital admission. Is also expected that the experimental group will improve the functional capacity and muscular strength, and they will have a lower risk of fragility in long term. It is also expected that the patients in the experimental group will soon be able to normalize their oxygen consumption a year after lung transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Usual care treatmentThe control group receives regular treatment in the ICU, which includes muscle strengthening exercises, passive/assisted or active mobilizations, and respiratory physiotherapy with breathing muscle strengthening in a medium load (initially at 40% load from results in MIP). |
| Group 2 | Experimental | Other: New Treatment Protocol-MotoMED®The experimental group receives a new early rehabilitation program based on a patient's in-bed cycling that allows controlled and adapted training to the patient's situation, along with coordinated exercise with neuromuscular electrostimulation and respiratory physiotherapy with breathing muscle strengthening in a high load (initially at 60% load from results in MIP). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral or bilateral lung transplantation.
- Age criteria (From 18 to 70 years old).
- Start the rehabilitation program between the first 15 days after lung transplantation.
Key exclusion criteria (4 listed)
- Do not meet inclusion criteria.
- Fulfill some criterion of absolute contraindication for the use of electrostimulation in the lower extremities (pacemaker, pregnancy or unstable fracture that requires absolute rest and immobilization.
- Cognitive or psychiatric alteration that does not allow you to participate in the project.
- Not wanting to participate in the study.
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 |
|---|---|---|
| Usual care treatmentAlso: usual careAll evaluations are the same in both groups: Baseline evaluation ICU admission (If patient hemodynamically stable initiates physiotherapy treatment within the first 15 days after surgery). Treatment:A daily session from Monday to Friday of 40 minutes according to patient functional status: Passive or active-assisted or active mobilizations, muscle enhancement, respiratory physiotherapy and inspiratory muscle training at 40% of the PIM value. 2nd evaluation when patient has a RASS -1/0 score: 3rd evaluation when ICU discharge. Treatment ward: A 60-minute daily session according to patient functional status in the gym (physiotherapy area in hospital): Cycloergometer, muscle enhancement, respiratory physiotherapy and inspiratory muscle training. 4th evaluation when hospital discharge 5th evaluation (1 month after discharge) 6th evaluation (4 months after discharge) 7th evaluation (1 year after surgery) | Other | Group 1 |
| New Treatment Protocol-MotoMED®Also: MotoMED + NEMSBaseline evaluation ICU admission (If patient hemodynamically stable initiates physiotherapy treatment within the first 15 days after surgery). Treatment: A daily session from Monday to Friday of 40 minutes (5 minutes of warm-up, 30 of training and 5 of cooling). Combined quadriceps / biceps femoris electrotherapy: at 200-350μs intensity. Respiratory physiotherapy with the objectives: Airway permeabilization and inspiratory muscle training at 60% of the PIM value. 2nd evaluation when patient has a RASS -1/0 score: 3rd evaluation when ICU discharge. Treatment ward: A 60-minute daily session according to patient functional status in the gym (physiotherapy area in hospital): Cycloergometer, muscle enhancement, respiratory physiotherapy and inspiratory muscle training. 4th evaluation when hospital discharge 5th evaluation (1 month after discharge) 6th evaluation (4 months after discharge) 7th evaluation (1 year after surgery) | Other | Group 2 |
Primary outcome
Exercise Capacity
Time frame: Through study completion, an average of 1 year
Measured with 6MWT It will be measured in different moments: Baseline Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge
Muscle strength
Time frame: Through study completion, an average of 1 year
Measured with dynamometer It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge
Muscle mass
Time frame: Through study completion, an average of 1 year
Measured with bioimpedanciometry It will be measured in different moments: Baseline Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge
Respiratory muscle strength
Time frame: Through study completion, an average of 1 year
Measured with MIP and MEP It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge
Cough strength
Time frame: Through study completion, an average of 1 year
Measured with Peak Cough Flow It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge
4 secondary outcomes
Frailty
Time frame: Through study completion, an average of 1 year
Muscle balance
Time frame: Through study completion, an average of 1 year
Pulmonary Capacity
Time frame: Through study completion, an average of 1 year
Oxygen consumption
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 21940789du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, King TE Jr, Lancaster L, Noble PW, Sahn SA, Thomeer M, Valeyre D, Wells AU. Forced vital capacity in patients with idiopathic pulmonary fibrosis: test properties and minimal clinically important difference. Am J Respir Crit Care Med. 2011 Dec 15;184(12):1382-9. doi: 10.1164/rccm.201105-0840OC. Epub 2011 Sep 22.
- Background: PubMed 21536362Roman A, Ussetti P, Sole A, Zurbano F, Borro JM, Vaquero JM, de Pablo A, Morales P, Blanco M, Bravo C, Cifrian J, de la Torre M, Gamez P, Laporta R, Monforte V, Mons R, Salvatierra A, Santos F, Sole J, Varela A; Sociedad Espanola de Neumologia y Cirugia Toracica. Guidelines for the selection of lung transplantation candidates. Arch Bronconeumol. 2011 Jun;47(6):303-9. doi: 10.1016/j.arbres.2011.03.007. Epub 2011 May 4. English, Spanish.
- Background: PubMed 22939738Coll E, Santos F, Ussetti P, Canela M, Borro JM, De La Torre M, Varela A, Zurbano F, Mons R, Morales P, Pastor J, Salvatierra A, de Pablo A, Gamez P, Moreno A, Sole J, Roman A. The Spanish Lung Transplant Registry: first report of results (2006-2010). Arch Bronconeumol. 2013 Feb;49(2):70-8. doi: 10.1016/j.arbres.2012.06.001. Epub 2012 Aug 28. English, Spanish.
- Background: PubMed 25085497Weill D, Benden C, Corris PA, Dark JH, Davis RD, Keshavjee S, Lederer DJ, Mulligan MJ, Patterson GA, Singer LG, Snell GI, Verleden GM, Zamora MR, Glanville AR. A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2015 Jan;34(1):1-15. doi: 10.1016/j.healun.2014.06.014. Epub 2014 Jun 26.
- Background: PubMed 30174910Weill D. Lung transplantation: indications and contraindications. J Thorac Dis. 2018 Jul;10(7):4574-4587. doi: 10.21037/jtd.2018.06.141.
- Background: PubMed 22300103Shigemura N, Bhama J, Gries CJ, Kawamura T, Crespo M, Johnson B, Zaldonis D, Pilewski J, Toyoda Y, Bermudez C. Lung transplantation in patients with prior cardiothoracic surgical procedures. Am J Transplant. 2012 May;12(5):1249-55. doi: 10.1111/j.1600-6143.2011.03946.x. Epub 2012 Feb 2.
- Background: PubMed 18724219Reynaud-Gaubert M, Mornex JF, Mal H, Treilhaud M, Dromer C, Quetant S, Leroy-Ladurie F, Guillemain R, Philit F, Dauriat G, Grenet D, Stern M. Lung transplantation for lymphangioleiomyomatosis: the French experience. Transplantation. 2008 Aug 27;86(4):515-20. doi: 10.1097/TP.0b013e31817c15df.
- Background: PubMed 7598576Detterbeck FC, Egan TM, Mill MR. Lung transplantation after previous thoracic surgical procedures. Ann Thorac Surg. 1995 Jul;60(1):139-43.
- Background: PubMed 15982615Curtis HJ, Bourke SJ, Dark JH, Corris PA. Lung transplantation outcome in cystic fibrosis patients with previous pneumothorax. J Heart Lung Transplant. 2005 Jul;24(7):865-9. doi: 10.1016/j.healun.2004.05.024.
- Background: PubMed 10673212American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):646-64. doi: 10.1164/ajrccm.161.2.ats3-00. No abstract available.
- Background: PubMed 21471066Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
- Background: PubMed 21616999du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, Lancaster L, Noble PW, Raghu G, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, King TE Jr. Ascertainment of individual risk of mortality for patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Aug 15;184(4):459-66. doi: 10.1164/rccm.201011-1790OC.
- Individual participant dataSharing planned: No
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Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
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.
Bernat Planas Pascual, PT, MSc principal investigator
Hospital Universitari Vall d'Hebron Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Treatment Protocol-MotoMED® in people with Lung Transplant and Rehabilitation, run by Hospital Universitari Vall d'Hebron Research Institute 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 4 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: status not confirmed, as of the sponsor's last update on 24 Nov 2020. 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?
Results are not available in the source record.
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?
Exercise Capacity (time frame: Through study completion, an average of 1 year). 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 NCT04244734, which also lists 22 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 24 Nov 2020.