Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD) (CHRONOBIO)

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Diseases
• Intervention / Treatment: Other: Pulmonary rehabilitation

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michaël RACODON, PhD; Phone Number: +33320223457; Email: mracodon@clinique-mitterie.com

Study Locations

• France
  • Lille, France, 59130
    • Recruiting
    • Clinique la Mitterie
    • Contact: Michaël RACODON, PhD; Phone Number: +33320223457; Email: mracodon@clinique-mitterie.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Morning group; Endurance and muscular exercise can be performed in the morning, either at 9:00am or 9:45am, or vice versa.	Other: Pulmonary rehabilitation; Pulmonary rehabilitation includes : Exercise re-training with resumption of physical activities; therapeutic patient education
Other: Afternoon group; Endurance and muscular exercise can be performed in the afternoon, from 3:00 pm to 3:45 pm, or vice versa.	Other: Pulmonary rehabilitation; Pulmonary rehabilitation includes : Exercise re-training with resumption of physical activities; therapeutic patient education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test (6MWT)	Walking distance in a test	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time limit test (Time-lim)	Endurance exercise holding time in seconds	0 to 900 secondes
Sit to stand test (STT)	The number of sit-to-stand repetitions during the test.	1 minute
Single arm curl Test (SAC)	The number of bends during the test	1 minute
Single-leg stance test (SLT)	The time for balance	1 minute
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.
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.

Collaborators and Investigators

• Sponsor: Michaël RACODON

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): January 2, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; chronic obstructive pulmonary disease; respiratory diseases; biological clock
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 2023-A00363-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The IPD sharing plan with other researchers is only available on site at the clinic.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No