Respiratory DiseasesCHRONOBIONCT06366113
Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Pulmonary rehabilitation in people with Respiratory Diseases, run by Michaël RACODON at 1 site in France.
Trial summary
Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies. The program should not be improved by introducing new subjects such as circadian rhythm. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Diseases
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2024to 1 Jul 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient with chronic obstructive pulmonary disease (COPD)
- Registered for respiratory re-education and rehabilitation at the Clinique de la Mitterie
- Number of rehabilitation sessions at least 18 over 4 weeks
- Written informed consent signed by the patient
- Membership of a social security
Who cannot join
- - cardiovascular contraindications to exercise
- unstable respiratory status (uncompensated respiratory acidosis)
- conditions interfering with the pulmonary rehabilitation process (progressive neuromuscular disease, psychiatric illness)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique la Mitterie
Lille, 59130
Michaël RACODON, PhD, +33320223457, mracodon@clinique-mitterie.com
About this study
Official title: Effect of Time of Exercise Re-training on Functional Capacity in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies.
The program should not be improved by introducing new subjects such as circadian rhythm.
Read the detailed description
Respiratory diseases are a leading cause of death in developed countries. To avoid complications and recurrences, secondary prevention in patients with respiratory diseases is essential. Pulmonary rehabilitation (PR) is a well-established and effective treatment that is supervised by medical professionals and conducted in dedicated centres. It has been shown to reduce hospital readmissions, secondary events, and patient mortality.
The timing of reconditioning is crucial. Previous studies have indicated that training times affect strength and power gains. Additionally, the time of day for training can significantly impact progress in aerobic capacity.
Disturbances to the biological clock can have consequences for people with respiratory pathologies, particularly an alteration in muscular function.
Therefore, studying the temporal specificity of exercise re-training in patients with respiratory diseases is of interest.
- Conditions
- Respiratory Diseases
- Being tested
- Pulmonary rehabilitation
- Keywords
- respiratory diseases, pulmonary rehabilitation, chronic obstructive pulmonary disease, biological clock
- Medical subject headings
- Respiratory Tract Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
Pulmonary rehabilitation includes :
- Exercise re-training with resumption of physical activities
- therapeutic patient education
| Study group | Role | What they receive |
|---|---|---|
| Morning group | Other | Endurance and muscular exercise can be performed in the morning, either at 9:00am or 9:45am, or vice versa. Receives: Other: Pulmonary rehabilitation |
| Afternoon group | Other | Endurance and muscular exercise can be performed in the afternoon, from 3:00 pm to 3:45 pm, or vice versa. Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test (6MWT)
Walking distance in a test
Measured: 15 minutes
Secondary outcomes (6)
Time limit test (Time-lim)
Endurance exercise holding time in seconds
Measured: 0 to 900 secondes
Sit to stand test (STT)
The number of sit-to-stand repetitions during the test.
Measured: 1 minute
Single arm curl Test (SAC)
The number of bends during the test
Measured: 1 minute
Single-leg stance test (SLT)
The time for balance
Measured: 1 minute
Hospital Anxiety and Depression Scale (HAD)
Hospital Anxiety and Depression score
Measured: 10 minutes. The maximum mark for each score is 21 and the minimum mark is 0. The higher the score, the more depressed or anxious the person.
Pittsburgh Sleep Quality Index
Sleep quality score
Measured: 10 minutes. The total score ranges from 0 to 21, with 0 indicating no difficulties and 21 indicating major difficulties.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start2 Jan 2024
- Primary completion2 Jan 2024
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michaël RACODON
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michaël RACODON, Clinique de la Mitterie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366113
- Sponsor's protocol ID
- 2023-A00363-42
- Acronym
- CHRONOBIO
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD sharing plan with other researchers is only available on site at the clinic.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time of Exercise Re-training on Functional Capacity in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT06366113
- Acronym / sponsor ID
- CHRONOBIO / 2023-A00363-42
- Conditions
- Respiratory Diseases
- Keywords
- respiratory diseases, pulmonary rehabilitation, chronic obstructive pulmonary disease, biological clock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Michaël RACODONUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 Apr 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 (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies.
The program should not be improved by introducing new subjects such as circadian rhythm.
Detailed description
Respiratory diseases are a leading cause of death in developed countries. To avoid complications and recurrences, secondary prevention in patients with respiratory diseases is essential. Pulmonary rehabilitation (PR) is a well-established and effective treatment that is supervised by medical professionals and conducted in dedicated centres. It has been shown to reduce hospital readmissions, secondary events, and patient mortality.
The timing of reconditioning is crucial. Previous studies have indicated that training times affect strength and power gains. Additionally, the time of day for training can significantly impact progress in aerobic capacity.
Disturbances to the biological clock can have consequences for people with respiratory pathologies, particularly an alteration in muscular function.
Therefore, studying the temporal specificity of exercise re-training in patients with respiratory diseases is of interest.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning group | Other | Other: Pulmonary rehabilitationEndurance and muscular exercise can be performed in the morning, either at 9:00am or 9:45am, or vice versa. |
| Afternoon group | Other | Other: Pulmonary rehabilitationEndurance and muscular exercise can be performed in the afternoon, from 3:00 pm to 3:45 pm, or vice versa. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Patient with chronic obstructive pulmonary disease (COPD)
- Registered for respiratory re-education and rehabilitation at the Clinique de la Mitterie
- Number of rehabilitation sessions at least 18 over 4 weeks
- Written informed consent signed by the patient
Key exclusion criteria (3 listed)
- - cardiovascular contraindications to exercise
- unstable respiratory status (uncompensated respiratory acidosis)
- conditions interfering with the pulmonary rehabilitation process (progressive neuromuscular disease, psychiatric illness)
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 |
|---|---|---|
| Pulmonary rehabilitationPulmonary rehabilitation includes : * Exercise re-training with resumption of physical activities * therapeutic patient education | Other | Afternoon group, Morning group |
Primary outcome
6-minute walk test (6MWT)
Time frame: 15 minutes
Walking distance in a test
6 secondary outcomes
Time limit test (Time-lim)
Time frame: 0 to 900 secondes
Sit to stand test (STT)
Time frame: 1 minute
Single arm curl Test (SAC)
Time frame: 1 minute
Single-leg stance test (SLT)
Time frame: 1 minute
Hospital Anxiety and Depression Scale (HAD)
Time frame: 10 minutes. The maximum mark for each score is 21 and the minimum mark is 0. The higher the score, the more depressed or anxious the person.
Pittsburgh Sleep Quality Index
Time frame: 10 minutes. The total score ranges from 0 to 21, with 0 indicating no difficulties and 21 indicating major difficulties.
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 12 Jan 2026.
- Individual participant dataSharing planned: Undecided. The IPD sharing plan with other researchers is only available on site at the clinic.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Respiratory Diseases, run by Michaël RACODON 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 6 inclusion and 3 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 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Michaël RACODON, PhD (+33320223457, mracodon@clinique-mitterie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (6MWT) (time frame: 15 minutes). 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 12 Jan 2026.