Chronic Respiratory DiseaseWANTTOMOVENCT06579612
The Benefits of Individualized Follow-up With a Sport-Health Professional in the Care of Patients With Chronic Respiratory Diseases
A study testing Personalized follow-up and support in people with Chronic Respiratory Disease, run by University Hospital, Brest at 2 sites in France.
Trial summary
Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Respiratory Disease
- What is being tested?
- Personalized follow-up and support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Nov 2024to 7 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of one or more chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, diffuse interstitial lung disease, bronchiectasis, obstructive sleep apnea syndrome, etc.).
- Participation in a respiratory pulmonary program
- Have given consent
- Patient of legal age
- Patient affiliated to Social Security
Who cannot join
- Any medical contraindication to the practice of adapted physical activity in rehabilitation
- Patients under guardianship or curatorship
- Patients deprived of their liberty
- Patients over 80 years of age at the time of inclusion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Baptiste Chéhère, PhD contact
France2 sites, 2 recruiting
- Recruiting
CHU de Brest
Brest, 29609
Marie-Agnès GIROUX-METGES, MD, PhD, +33298347366, marie-agnes.metges@chu-brest.fr
Baptiste CHEHERE, PhD, baptiste.chehere@univ-brest.fr
- Recruiting
CH des Pays de Morlaix
Morlaix, 29672
Marc BEAUMONT, +33298626160, marc.beaumont@chu-brest.fr
About this study
Official title: The Benefits of Individualized Follow-up With a Sport-Health Professional in the Care of Patients With Chronic Respiratory Diseases, to Maintain Long-term Benefits After a Respiratory Rehabilitation Program
Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term.
The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits.
This study concerns patients with a diagnosis of one or more chronic respiratory diseases.
It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:
- a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group)
- a control group receiving only usual care
Read the detailed description
Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term.
The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits.
This study concerns patients with a diagnosis of one or more chronic respiratory diseases.
It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:
- a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group)
- a control group receiving only usual care
Each patient is followed up for 24 months with a visit every 6 months. A total of 352 subjects will be recruited
- Conditions
- Chronic Respiratory Disease
- Being tested
- Personalized follow-up and support
- Keywords
- chronic respiratory disease, pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized follow-up and supportOther
After a pulmonary rehabilitation program, an interview with a professional will enable the professional to identify the barriersand enablers of physical activity engagement, and to identify (with the patient) a plan for maintaining a physical activities adapted in daily life. Adapted solutions will then be proposed.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Patient in the control arm will beneficiate from commun practice |
| Experimental arm | Experimental | Patient in the control arm will beneficiate from a personalized follow-up and support after a pulmonary rehabilitation program Receives: Other: Personalized follow-up and support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in average number of daily steps
The difference in average daily steps measured by accelerometry (over 7 days) at the end of the pulmonary rehabilitation course (V1) and after 24 months of personalized follow-up (V5).
Measured: At inclusion (V1) and at 24 Months (V5)
Secondary outcomes (13)
Cost-utility comparison between the two groups
The cost-utility comparison between the two groups at 24 months was carried out by means of a medico-economic evaluation. This evaluation contains 5 items : direct medical costs; costs of care in the experimental group; incremental cost-utility ratio at 24 months; medical indicator results measured in QALYs and health-related quality of life.
Measured: At 24 Months (V5)
Comparison of changes in physical activity levels between the two groups
the evolution of physical activity levels is assessed with levels of activity :
- Sedentary time (min/day)
- Time spent in activity with light intensity (min/day)
- Time spent in activity with moderate intensity (min/day)
- Time spent in activity with vigorous intensity (min/day)
Measured: At 24 Months (V5)
Comparison of changes in physical capacities between the two groups
The evolution of physical capacities is assessed with walking distance measured in the 6-minute walk test.
The 6-minute walk test: total walked distance (in metres). The test will be performed twice, the best performance will be kept as reference value.
Measured: A 24 Months (V5)
Comparison of changes in physical capacities between the two groups
The evolution of physical capacities is assessed with the endurance time on ergocycle at 80% of peak power, in seconds.
Measured: A 24 Months (V5)
Comparison of changes in physical capacities between the two groups
The evolution of physical capacities is assessed with the quadriceps strength measured in the maximal isometric contraction test.
Measured: A 24 Months (V5)
Comparison of changes in symptoms between the two groups
The evolution of symptoms is assessed with dyspnoea score (DYSPNEA-12). The DYSPNEA-12 comprised of 12 different breathlessness descriptors with each scored on a four-item scale (none-0, mild-1, moderate2, severe-3). Item scores are summed (D-12 Total) and can be divided into sub-scores reflecting Physical and Affective domains.
Measured: At 24 Months (V5)
Comparison of changes in psychological dimensions between the two groups
The evolution of psychological dimensions is assessed with the motivation scores according to different levels of regulation assessed by the Motivation for Physical Activity for Health Purposes Scale (EMAPS). This questionnaire includes 18 items. The EMAPS is used to evaluate the motivation to practice physical activities. The answer to questions goes from 1 to 7 with 1 (does not match at all) and 7 (matches very strongly).
Measured: At 24 Months (V5)
Comparison of changes in psychological dimensions between the two groups
The evolution of psychological dimensions is assessed with the anxiety and depression scores using the Hospital Anxiety and Depression scale (HAD). This questionnaire includes 7 items for depression and 7 items for anxiety. Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and for depression. A score of 0 to 7 for either subscale could be regarded as being in the normal range, a score of 11 or higher indicating probable presence ('caseness') of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state.
Measured: At 24 Months (V5)
Comparison of changes in health indicator between the two groups
The evolution of health indicator is assessed with a St George's Respiratory Questionnaire (SGRQ). This questionnaire comprises 3 components: the symptom component assesses the effects of respiratory symptoms, their frequency and severity, the activity component looks at activities that cause and/or are limited by breathlessness, and the impact component assesses the disruption to social and psychological functioning induced by the disease. The total score ranges from 100 (low quality of life) to 0 (excellent quality of life).
Measured: At 24 Months (V5)
Comparison of changes in quality of life indicator between the two groups
The evolution of quality of life indicator is assessed with EuroQol " five dimensions questionnaire " (EQ5DL). EQ5DL is a questionnaire including 5 items mobility, personal care, usual activities, pain/discomfort and anxiety/depression.
Measured: At 24 Months (V5)
Comparison of changes in parameters (barriers and levers to physical activity) between the two groups
The evolution of parameters (barriers and levers to physical activity) is assessed with the socioeconomic investigation results. This questionnaire was created for this study to gather information on the socio-economic and environmental profile of people in relation to the practice of physical activity (Barriers and levers to practice, transportation, cost of practicing physical activity, place of practice).
Measured: At 24 Months (V5)
Comparison of changes in physical capacities between the two groups
The evolution of physical capacities is assessed with the Forced Expiratory Volume in 1 Second measured by spirometry
Measured: At 24 Months (V5)
Comparison of changes in physical capacities between the two groups
The evolution of physical capacities is assessed with the Forced Vital Capacity measured by spirometry
Measured: At 24 Months (V5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start7 Nov 2024
- Primary completion7 Nov 2029 (estimated)
- Study completion7 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled superiority trial in parallel arms (1:1 ratio) comparing personalized follow-up and support after a pulmonary rehabilitation program (experimental group) versus a control group receiving only usual care,
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Agnès GIROUX-METGES, MD, PhD, Principal investigator, Brest Universty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579612
- Sponsor's protocol ID
- 29BRC22.0256
- Acronym
- WANTTOMOVE
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Individualized Follow-up With a Sport-Health Professional in the Care of Patients With Chronic Respiratory Diseases, to Maintain Long-term Benefits After a Respiratory Rehabilitation Program
- ClinicalTrials.gov ID
- NCT06579612
- Acronym / sponsor ID
- WANTTOMOVE / 29BRC22.0256
- Conditions
- Chronic Respiratory Disease
- Keywords
- chronic respiratory disease, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 7 Nov 2029 (estimated)
- Study completion
- 7 Nov 2029 (estimated)
- First posted
- 30 Aug 2024 (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 rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term.
The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits.
This study concerns patients with a diagnosis of one or more chronic respiratory diseases.
It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:
- a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group)
- a control group receiving only usual care
Detailed description
Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term.
The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits.
This study concerns patients with a diagnosis of one or more chronic respiratory diseases.
It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:
- a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group)
- a control group receiving only usual care
Each patient is followed up for 24 months with a visit every 6 months. A total of 352 subjects will be recruited
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled superiority trial in parallel arms (1:1 ratio) comparing personalized follow-up and support after a pulmonary rehabilitation program (experimental group) versus a control group receiving only usual care,
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Patient in the control arm will beneficiate from commun practice |
| Experimental arm | Experimental | Other: Personalized follow-up and supportPatient in the control arm will beneficiate from a personalized follow-up and support after a pulmonary rehabilitation program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of one or more chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, diffuse interstitial lung disease, bronchiectasis, obstructive sleep apnea syndrome, etc.).
- Participation in a respiratory pulmonary program
- Have given consent
- Patient of legal age
- Patient affiliated to Social Security
Key exclusion criteria (4 listed)
- Any medical contraindication to the practice of adapted physical activity in rehabilitation
- Patients under guardianship or curatorship
- Patients deprived of their liberty
- Patients over 80 years of age at the time of inclusion.
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 |
|---|---|---|
| Personalized follow-up and supportAfter a pulmonary rehabilitation program, an interview with a professional will enable the professional to identify the barriersand enablers of physical activity engagement, and to identify (with the patient) a plan for maintaining a physical activities adapted in daily life. Adapted solutions will then be proposed. | Other | Experimental arm |
Primary outcome
Difference in average number of daily steps
Time frame: At inclusion (V1) and at 24 Months (V5)
The difference in average daily steps measured by accelerometry (over 7 days) at the end of the pulmonary rehabilitation course (V1) and after 24 months of personalized follow-up (V5).
13 secondary outcomes
Cost-utility comparison between the two groups
Time frame: At 24 Months (V5)
Comparison of changes in physical activity levels between the two groups
Time frame: At 24 Months (V5)
Comparison of changes in physical capacities between the two groups
Time frame: A 24 Months (V5)
Comparison of changes in physical capacities between the two groups
Time frame: A 24 Months (V5)
Comparison of changes in physical capacities between the two groups
Time frame: A 24 Months (V5)
Comparison of changes in symptoms between the two groups
Time frame: At 24 Months (V5)
Comparison of changes in psychological dimensions between the two groups
Time frame: At 24 Months (V5)
Comparison of changes in psychological dimensions between the two groups
Time frame: At 24 Months (V5)
Comparison of changes in health indicator between the two groups
Time frame: At 24 Months (V5)
Comparison of changes in quality of life indicator between the two groups
Time frame: At 24 Months (V5)
Comparison of changes in parameters (barriers and levers to physical activity) between the two groups
Time frame: At 24 Months (V5)
Comparison of changes in physical capacities between the two groups
Time frame: At 24 Months (V5)
Comparison of changes in physical capacities between the two groups
Time frame: At 24 Months (V5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Baptiste Chéhère, PhD contact
Marie-Agnès GIROUX-METGES, MD, PhD principal investigator
Brest Universty Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized follow-up and support in people with Chronic Respiratory Disease, run by University Hospital, Brest at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Agnès GIROUX-METGES, MD, PhD (+33298347366, marie-agnes.metges@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in average number of daily steps (time frame: At inclusion (V1) and at 24 Months (V5)). 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 26 Jun 2026.