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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06366113
Other study ID # 2023-A00363-42
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2024
Est. completion date July 1, 2024

Study information

Verified date April 2024
Source Clinique de la Mitterie
Contact Michaël RACODON, PhD
Phone +33320223457
Email mracodon@clinique-mitterie.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date July 1, 2024
Est. primary completion date January 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - - cardiovascular contraindications to exercise - unstable respiratory status (uncompensated respiratory acidosis) - conditions interfering with the pulmonary rehabilitation process (progressive neuromuscular disease, psychiatric illness)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary rehabilitation
Pulmonary rehabilitation includes : Exercise re-training with resumption of physical activities therapeutic patient education

Locations

Country Name City State
France Clinique la Mitterie Lille

Sponsors (1)

Lead Sponsor Collaborator
Michaël RACODON

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6-minute walk test (6MWT) Walking distance in a test 15 minutes
Secondary Time limit test (Time-lim) Endurance exercise holding time in seconds 0 to 900 secondes
Secondary Sit to stand test (STT) The number of sit-to-stand repetitions during the test. 1 minute
Secondary Single arm curl Test (SAC) The number of bends during the test 1 minute
Secondary Single-leg stance test (SLT) The time for balance 1 minute
Secondary Hospital Anxiety and Depression Scale (HAD) Hospital Anxiety and Depression score 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.
Secondary Pittsburgh Sleep Quality Index Sleep quality score 10 minutes. The total score ranges from 0 to 21, with 0 indicating no difficulties and 21 indicating major difficulties.
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