Respiratory RehabilitationRESPIRSONCT04279002
Association of Psycho-social Traits for the Benefit of a First Respiratory Rehabilitation Course - Exploratory Study.
An observational study of Respiratory Rehabilitation and Pulmonary Rehabilitation, run by University Hospital, Tours at 1 site in France.
Trial summary
Respiratory Rehabilitation (RR) is based on a comprehensive multidisciplinary program of personalized and tailored care for patients with chronic respiratory diseases. The effectiveness of RR in improving quality of life and exercise capacity has long been demonstrated in patients with chronic obstructive pulmonary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Rehabilitation, Pulmonary Rehabilitation
- What is being tested?
- Brief 15-question questionnaire
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2020to 24 Feb 2021
- 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: Patients having a chronic respiratory pathology and having carried out a respiratory rehabilitation program in the 5 years prior to inclusion at the Espace du Souffle in Tours (France).
Who may be able to join
- Age ≥ 18 years old.
- Completion of at least one respiratory rehabilitation course at the Espace du Souffle (Tours France) within the 5 years prior to inclusion.
- Participation Agreement (no opposition confirmed with the return of the questionnaire)
Who cannot join
- Protected adults (guardianship or trusteeship)
- Patient having expressed a refusal of contact for scientific purposes at the Espace du Souffle (Tours France)
Trial locations and contacts
1 site in 1 country.
About this study
Respiratory Rehabilitation (RR) is based on a comprehensive multidisciplinary program of personalized and tailored care for patients with chronic respiratory diseases.
The effectiveness of RR in improving quality of life and exercise capacity has long been demonstrated in patients with chronic obstructive pulmonary disease (COPD). More recently, its interest has been highlighted in other chronic respiratory pathologies: asthma, interstitial pathologies, cancer, restrictive pathologies or pulmonary arterial hypertension. Although the efficacy of RR has been well demonstrated on the scale of a patient population, the benefits derived on an individual scale remain unpredictable and variable from one individual to another, without knowing the major determinants of this benefit.
Read more
Empirically, RR professionals suspect an association between some psychosocial characteristics and the importance of the benefit derived by patients from RR programmes. Individual personality traits and their relationship to health status, integration into a group, interaction with other group members, and the existence of anxiety or depressive symptoms may be determinants of RR benefit. These psychosocial determinants could also play a central role in the patients' adherence to the long-term rehabilitation process.
The hypothesis being tested is that there is an association between personality traits, anxiety, depressive symptoms, social support, and the benefit of an initial course of RR and the subsequent continuation of maintenance practices.
Read the detailed description
Respiratory Rehabilitation (RR) is based on a comprehensive multidisciplinary program of personalized and tailored care for patients with chronic respiratory diseases. Carried out in small groups of patients, it offers effort re-training combined with therapeutic education and psychological and social care. It aims at the long-term change of life habits.
The effectiveness of RR in improving quality of life and exercise capacity has long been demonstrated in patients with chronic obstructive pulmonary disease (COPD). More recently, its interest has been highlighted in other chronic respiratory pathologies: asthma, interstitial pathologies, cancer, restrictive pathologies or pulmonary arterial hypertension. Although the efficacy of RR has been well demonstrated on the scale of a patient population, the benefits derived on an individual scale remain unpredictable and variable from one individual to another, without knowing the major determinants of this benefit.
Empirically, RR professionals suspect an association between some psychosocial characteristics and the importance of the benefit derived by patients from RR programmes. Individual personality traits and their relationship to health status, integration into a group, interaction with other group members, and the existence of anxiety or depressive symptoms may be determinants of RR benefit. These psychosocial determinants could also play a central role in the patients' adherence to the long-term rehabilitation process.
The hypothesis being tested is that there is an association between personality traits, anxiety, depressive symptoms, social support, and the benefit of an initial course of RR and the subsequent continuation of maintenance practices.
Main objective n°1: to describe the distribution of 17 psychosocial traits of interest in patients who had a major benefit from the initial RR stage (defined by a decrease ≥7 points of Saint George's Respiratory Questionnaire (SGRQ) compared to patients who did not have a major benefit (defined by a decrease <7 points of the SGRQ).
The 17 traits describe the following:
- Personality traits
- Existence of anxiety or depressive symptoms
- Self-assessment of health status and the degree of control that the subject feels he or she has over the disease.
- Felt social support
- Interpersonal dimensions
- General satisfaction of the subject
Secondary Objective 1 :
Describe the distribution of the 17 psychosocial traits of interest in patients who have implemented maintenance practices for at least one year after the 1st RR course (defined by paramedical care or participation in activities offered by a patient association or declaration of the maintenance of supervised physical activity), compared to patients who have not pursued such an activity or for whom this data is not available.
Secondary objective n°2: Describe the correlations between 17 psychosocial traits of interest and the variation of the following variables between the initial and final assessment of the first RR stage: SGRQ, VQ11 quality of life score, Modified Medical Research Council (mMRC) dyspnea scale, 6-minute walking distance.
- Being tested
- Brief 15-question questionnaire
- Keywords
- Personality traits, Anxiety, Depression, Social support
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief 15-question questionnaireOther
Questionnaire is mailed retrospectively to the respiratory rehabilitation program and aimed at targeting 17 psycho-social traits. Response time is estimated at 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Respiratory rehabilitation course | Patients who has completed at least one respiratory rehabilitation course at the Espace du Souffle (Tours France) within the 5 years prior to inclusion Receives: Other: Brief 15-question questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of 17 psychosocial traits of interest in patients who had a major benefit from the initial Respiratory Rehabilitation program
Patients who had a major benefit from the initial Respiratory Rehabilitation program is defined by a decrease ≥7 points of the SGRQ
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
Measured: At the inclusion
Secondary outcomes (5)
Distribution of the 17 psychosocial traits of interest in patients who have implemented maintenance practices for at least one year after the 1st Respiratory Rehabilitation program
Maintenance practices being defined by paramedical care or participation in activities offered by a patient association or declaration of continued supervised physical activity), compared to patients who have not pursued such an activity or for whom this data is not available.
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
Measured: At the inclusion
Assess correlations between between 17 psychosocial traits of interest and the variation of the SGRQ between the initial and final assessment of the first Respiratory Rehabilitation program
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
Measured: At the inclusion
Assess correlations between between 17 psychosocial traits of interest and the variation of the VQ11 quality of life score between the initial and final assessment of the first Respiratory Rehabilitation program
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
Measured: initial and final assessment of the first Respiratory Rehabilitation program
Assess correlations between between 17 psychosocial traits of interest and the variation of the mMRC dyspnea scale between the initial and final assessment of the first Respiratory Rehabilitation program
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
Measured: At the inclusion
Assess correlations between between 17 psychosocial traits of interest and the variation of the 6-minute walking distance between the initial and final assessment of the first Respiratory Rehabilitation program
The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start16 May 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory RehabilitationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent PLANTIER, MD-PhD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279002
- Sponsor's protocol ID
- RIPH3-RNI19/RESPIRSO
- Other IDs
- 2019-A02774-53
- Acronym
- RESPIRSO
- Status last verified
- May 2021
- First submitted
- 14 Feb 2020
- Last updated
- 18 May 2021
- 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 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Psycho-social Traits for the Benefit of a First Respiratory Rehabilitation Course - Exploratory Study.
- ClinicalTrials.gov ID
- NCT04279002
- Acronym / sponsor ID
- RESPIRSO / RIPH3-RNI19/RESPIRSO
- Keywords
- Personality traits, Anxiety, Depression, Social support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 16 May 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 20 Feb 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.
Respiratory Rehabilitation (RR) is based on a comprehensive multidisciplinary program of personalized and tailored care for patients with chronic respiratory diseases.
The effectiveness of RR in improving quality of life and exercise capacity has long been demonstrated in patients with chronic obstructive pulmonary disease (COPD). More recently, its interest has been highlighted in other chronic respiratory pathologies: asthma, interstitial pathologies, cancer, restrictive pathologies or pulmonary arterial hypertension. Although the efficacy of RR has been well demonstrated on the scale of a patient population, the benefits derived on an individual scale remain unpredictable and variable from one individual to another, without knowing the major determinants of this benefit.
Empirically, RR professionals suspect an association between some psychosocial characteristics and the importance of the benefit derived by patients from RR programmes. Individual personality traits and their relationship to health status, integration into a group, interaction with other group members, and the existence of anxiety or depressive symptoms may be determinants of RR benefit. These psychosocial determinants could also play a central role in the patients' adherence to the long-term rehabilitation process.
The hypothesis being tested is that there is an association between personality traits, anxiety, depressive symptoms, social support, and the benefit of an initial course of RR and the subsequent continuation of maintenance practices.
Detailed description
Respiratory Rehabilitation (RR) is based on a comprehensive multidisciplinary program of personalized and tailored care for patients with chronic respiratory diseases. Carried out in small groups of patients, it offers effort re-training combined with therapeutic education and psychological and social care. It aims at the long-term change of life habits.
The effectiveness of RR in improving quality of life and exercise capacity has long been demonstrated in patients with chronic obstructive pulmonary disease (COPD). More recently, its interest has been highlighted in other chronic respiratory pathologies: asthma, interstitial pathologies, cancer, restrictive pathologies or pulmonary arterial hypertension. Although the efficacy of RR has been well demonstrated on the scale of a patient population, the benefits derived on an individual scale remain unpredictable and variable from one individual to another, without knowing the major determinants of this benefit.
Empirically, RR professionals suspect an association between some psychosocial characteristics and the importance of the benefit derived by patients from RR programmes. Individual personality traits and their relationship to health status, integration into a group, interaction with other group members, and the existence of anxiety or depressive symptoms may be determinants of RR benefit. These psychosocial determinants could also play a central role in the patients' adherence to the long-term rehabilitation process.
The hypothesis being tested is that there is an association between personality traits, anxiety, depressive symptoms, social support, and the benefit of an initial course of RR and the subsequent continuation of maintenance practices.
Main objective n°1: to describe the distribution of 17 psychosocial traits of interest in patients who had a major benefit from the initial RR stage (defined by a decrease ≥7 points of Saint George's Respiratory Questionnaire (SGRQ) compared to patients who did not have a major benefit (defined by a decrease <7 points of the SGRQ).
The 17 traits describe the following:
- Personality traits
- Existence of anxiety or depressive symptoms
- Self-assessment of health status and the degree of control that the subject feels he or she has over the disease.
- Felt social support
- Interpersonal dimensions
- General satisfaction of the subject
Secondary Objective 1 :
Describe the distribution of the 17 psychosocial traits of interest in patients who have implemented maintenance practices for at least one year after the 1st RR course (defined by paramedical care or participation in activities offered by a patient association or declaration of the maintenance of supervised physical activity), compared to patients who have not pursued such an activity or for whom this data is not available.
Secondary objective n°2: Describe the correlations between 17 psychosocial traits of interest and the variation of the following variables between the initial and final assessment of the first RR stage: SGRQ, VQ11 quality of life score, Modified Medical Research Council (mMRC) dyspnea scale, 6-minute walking distance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory rehabilitation course | – | Other: Brief 15-question questionnairePatients who has completed at least one respiratory rehabilitation course at the Espace du Souffle (Tours France) within the 5 years prior to inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a chronic respiratory pathology and having carried out a respiratory rehabilitation program in the 5 years prior to inclusion at the Espace du Souffle in Tours (France).
Key inclusion criteria (3 listed)
- Age ≥ 18 years old.
- Completion of at least one respiratory rehabilitation course at the Espace du Souffle (Tours France) within the 5 years prior to inclusion.
- Participation Agreement (no opposition confirmed with the return of the questionnaire)
Key exclusion criteria (2 listed)
- Protected adults (guardianship or trusteeship)
- Patient having expressed a refusal of contact for scientific purposes at the Espace du Souffle (Tours France)
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 |
|---|---|---|
| Brief 15-question questionnaireQuestionnaire is mailed retrospectively to the respiratory rehabilitation program and aimed at targeting 17 psycho-social traits. Response time is estimated at 10 minutes | Other | Respiratory rehabilitation course |
Primary outcome
Distribution of 17 psychosocial traits of interest in patients who had a major benefit from the initial Respiratory Rehabilitation program
Time frame: At the inclusion
Patients who had a major benefit from the initial Respiratory Rehabilitation program is defined by a decrease ≥7 points of the SGRQ The 17 psycho-social traits are assessed using a short 15-item questionnaire mailed retrospectively to the Respiratory Rehabilitation Program.
5 secondary outcomes
Distribution of the 17 psychosocial traits of interest in patients who have implemented maintenance practices for at least one year after the 1st Respiratory Rehabilitation program
Time frame: At the inclusion
Assess correlations between between 17 psychosocial traits of interest and the variation of the SGRQ between the initial and final assessment of the first Respiratory Rehabilitation program
Time frame: At the inclusion
Assess correlations between between 17 psychosocial traits of interest and the variation of the VQ11 quality of life score between the initial and final assessment of the first Respiratory Rehabilitation program
Time frame: initial and final assessment of the first Respiratory Rehabilitation program
Assess correlations between between 17 psychosocial traits of interest and the variation of the mMRC dyspnea scale between the initial and final assessment of the first Respiratory Rehabilitation program
Time frame: At the inclusion
Assess correlations between between 17 psychosocial traits of interest and the variation of the 6-minute walking distance between the initial and final assessment of the first Respiratory Rehabilitation program
Time frame: At the inclusion
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 18 May 2021.
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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.
Laurent PLANTIER, MD-PhD study director
University Hospital, Tours
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 Rehabilitation and Pulmonary Rehabilitation, run by University Hospital, Tours 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 3 inclusion and 2 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 18 May 2021. 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?
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?
Distribution of 17 psychosocial traits of interest in patients who had a major benefit from the initial Respiratory Rehabilitation program (time frame: At the inclusion). 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 18 May 2021.