Respiratory InsufficiencyNCT03636802
Study of the Prevalence of Painful Symptoms of the Musculoskeletal System After Lung Transplantation
An observational study of Respiratory Insufficiency, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Questionnaire BPI
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2018to Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient registered on the lung transplant waiting list of the CHU de Marseille
Who may be able to join
- Patient over 18
- Having agreed to no opposition
- Registered on the lung transplant waiting list of the CHU de Marseille
- Able to read, understand and complete the self-questionnaires of the study
Who cannot join
- Patient under 18 years
- Patient refusing follow up until 12 months post transplant
- Pregnant women, persons deprived of their liberty, persons under guardianship or trusteeship, persons in an emergency situation
- Person not affiliated to a social security scheme or not entitled to
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
PHILIPPE GIOVANNETTI, +33 491366141, Philippe.GIOVANNETTI@ap-hm.fr
About this study
Official title: Study of the Prevalence, Nature and Contributing Factors of Painful Symptoms of the Musculoskeletal System After Lung Transplantation; Impact on Physical Activity and Quality of Life
Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Its main indications are: cystic fibrosis and other bronchial diseases, emphysema , interstitial lung diseases with idiopathic pulmonary fibrosis in the foreground, and severe pulmonary hypertension.
The evocation of osteo-articular and musculotendinous pain symptoms in the aftermath of PT is frequent and very diversified. These complications are poorly codified and hinder the rehabilitation and early resumption of physical activity and sports. Few data are available on this subject in the literature.
Read more
Following transplantation, improvements in respiratory function, quality of life, and exercise capacity are observed, with large inter-individual variations;
Patients are encouraged to resume physical activity, initially as part of a rehabilitation exercise.
Among the factors limiting exercise, some have been more widely studied, such as muscular deconditioning related to pre-existing chronic respiratory insufficiency , prolonged stay in intensive care, side effects of transplant-related treatments (corticosteroids and immunosuppressants).
Pain is also a factor limiting the recovery of physical activity and quality of life. Pain related directly to thoracotomy surgery has been explored but there is little data available on musculoskeletal pain.
The purpose of this study is to better understand the musculoskeletal pain occurring in the aftermath of a lung transplantation. Conducting this study for a period of 1 year will allow you to move away from the immediate post-transplant time, and the pain associated with the transplant will no longer have any interference.
The main objective of our study is to better know the prevalence of algic manifestations of the musculoskeletal system (osteo-articular, musculotendinous ...) occurring in the year following a TP, and may constitute a brake on the rehabilitation of the musculoskeletal system. effort and recovery of physical activity or sport.
Read the detailed description
Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Its main indications are: cystic fibrosis and other bronchial diseases, emphysema (primary deficit or in the context of COPD), interstitial lung diseases with idiopathic pulmonary fibrosis in the foreground, and severe pulmonary hypertension.
The evocation of osteo-articular and musculotendinous pain symptoms in the aftermath of PT is frequent and very diversified. These complications are poorly codified and hinder the rehabilitation and early resumption of physical activity and sports. Few data are available on this subject in the literature.
Following transplantation, improvements in respiratory function, quality of life, and exercise capacity are observed, with large inter-individual variations.
Patients are encouraged to resume physical activity, initially as part of a rehabilitation exercise.
Among the factors limiting exercise, some have been more widely studied, such as muscular deconditioning related to pre-existing chronic respiratory insufficiency, prolonged stay in intensive care, side effects of transplant-related treatments (corticosteroids and immunosuppressants).
Pain is also a factor limiting the recovery of physical activity and quality of life. Pain related directly to thoracotomy surgery has been explored but there is little data available on musculoskeletal pain.
The purpose of this study is to better understand the musculoskeletal pain occurring in the aftermath of a lung transplantation. Conducting this study for a period of 1 year will allow you to move away from the immediate post-transplant time, and the pain associated with the transplant will no longer have any interference.
The main objective of our study is to better know the prevalence of algic manifestations of the musculoskeletal system (osteo-articular, musculotendinous ...) occurring in the year following a TP, and may constitute a brake on the rehabilitation of the musculoskeletal system. effort and recovery of physical activity or sport.
- Conditions
- Respiratory Insufficiency
- Being tested
- Questionnaire BPI
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire BPIOther
Brief Pain Inventory (BPI) This is a scale of self-assessment, the Concise Pain Questionnaire in French. For all adult patients For any type of pain This is to ask the patient to answer questions in order to learn about us characteristics of his pain (its intensity and its repercussions on the plane biopsychosocial).
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUP | Patient with respiratory failure and on a lung transplant waiting list Receives: Other: Questionnaire BPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of patients with symptoms of the musculoskeletal system
numbers of patients presenting symptoms of the musculoskeletal system during the study
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start31 May 2018
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636802
- Sponsor's protocol ID
- 2017-48
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence, Nature and Contributing Factors of Painful Symptoms of the Musculoskeletal System After Lung Transplantation; Impact on Physical Activity and Quality of Life
- ClinicalTrials.gov ID
- NCT03636802
- Acronym / sponsor ID
- 2017-48
- Conditions
- Respiratory Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Aug 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.
Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Its main indications are: cystic fibrosis and other bronchial diseases, emphysema , interstitial lung diseases with idiopathic pulmonary fibrosis in the foreground, and severe pulmonary hypertension.
The evocation of osteo-articular and musculotendinous pain symptoms in the aftermath of PT is frequent and very diversified. These complications are poorly codified and hinder the rehabilitation and early resumption of physical activity and sports. Few data are available on this subject in the literature.
Following transplantation, improvements in respiratory function, quality of life, and exercise capacity are observed, with large inter-individual variations;
Patients are encouraged to resume physical activity, initially as part of a rehabilitation exercise.
Among the factors limiting exercise, some have been more widely studied, such as muscular deconditioning related to pre-existing chronic respiratory insufficiency , prolonged stay in intensive care, side effects of transplant-related treatments (corticosteroids and immunosuppressants).
Pain is also a factor limiting the recovery of physical activity and quality of life. Pain related directly to thoracotomy surgery has been explored but there is little data available on musculoskeletal pain.
The purpose of this study is to better understand the musculoskeletal pain occurring in the aftermath of a lung transplantation. Conducting this study for a period of 1 year will allow you to move away from the immediate post-transplant time, and the pain associated with the transplant will no longer have any interference.
The main objective of our study is to better know the prevalence of algic manifestations of the musculoskeletal system (osteo-articular, musculotendinous ...) occurring in the year following a TP, and may constitute a brake on the rehabilitation of the musculoskeletal system. effort and recovery of physical activity or sport.
Detailed description
Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Its main indications are: cystic fibrosis and other bronchial diseases, emphysema (primary deficit or in the context of COPD), interstitial lung diseases with idiopathic pulmonary fibrosis in the foreground, and severe pulmonary hypertension.
The evocation of osteo-articular and musculotendinous pain symptoms in the aftermath of PT is frequent and very diversified. These complications are poorly codified and hinder the rehabilitation and early resumption of physical activity and sports. Few data are available on this subject in the literature.
Following transplantation, improvements in respiratory function, quality of life, and exercise capacity are observed, with large inter-individual variations.
Patients are encouraged to resume physical activity, initially as part of a rehabilitation exercise.
Among the factors limiting exercise, some have been more widely studied, such as muscular deconditioning related to pre-existing chronic respiratory insufficiency, prolonged stay in intensive care, side effects of transplant-related treatments (corticosteroids and immunosuppressants).
Pain is also a factor limiting the recovery of physical activity and quality of life. Pain related directly to thoracotomy surgery has been explored but there is little data available on musculoskeletal pain.
The purpose of this study is to better understand the musculoskeletal pain occurring in the aftermath of a lung transplantation. Conducting this study for a period of 1 year will allow you to move away from the immediate post-transplant time, and the pain associated with the transplant will no longer have any interference.
The main objective of our study is to better know the prevalence of algic manifestations of the musculoskeletal system (osteo-articular, musculotendinous ...) occurring in the year following a TP, and may constitute a brake on the rehabilitation of the musculoskeletal system. effort and recovery of physical activity or sport.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | – | Other: Questionnaire BPIPatient with respiratory failure and on a lung transplant waiting list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient registered on the lung transplant waiting list of the CHU de Marseille
Key inclusion criteria (4 listed)
- Patient over 18
- Having agreed to no opposition
- Registered on the lung transplant waiting list of the CHU de Marseille
- Able to read, understand and complete the self-questionnaires of the study
Key exclusion criteria (4 listed)
- Patient under 18 years
- Patient refusing follow up until 12 months post transplant
- Pregnant women, persons deprived of their liberty, persons under guardianship or trusteeship, persons in an emergency situation
- Person not affiliated to a social security scheme or not entitled to
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 |
|---|---|---|
| Questionnaire BPIBrief Pain Inventory (BPI) This is a scale of self-assessment, the Concise Pain Questionnaire in French. For all adult patients For any type of pain This is to ask the patient to answer questions in order to learn about us characteristics of his pain (its intensity and its repercussions on the plane biopsychosocial). | Other | EXPERIMENTAL GROUP |
Primary outcome
numbers of patients with symptoms of the musculoskeletal system
Time frame: 1 years
numbers of patients presenting symptoms of the musculoskeletal system during the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 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 17 Aug 2018. 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 France. 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?
Contact PHILIPPE GIOVANnETTI (+33 491366141, Philippe.GIOVANNETTI@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of patients with symptoms of the musculoskeletal system (time frame: 1 years). 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 17 Aug 2018.