NCT06366113

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2024Jul 2026

Study Start

First participant enrolled

January 2, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

April 10, 2024

Last Update Submit

January 9, 2026

Conditions

Keywords

respiratory diseasespulmonary rehabilitationchronic obstructive pulmonary diseasebiological clock

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk test (6MWT)

    Walking distance in a test

    15 minutes

Secondary Outcomes (6)

  • Time limit test (Time-lim)

    0 to 900 secondes

  • Sit to stand test (STT)

    1 minute

  • Single arm curl Test (SAC)

    1 minute

  • Single-leg stance test (SLT)

    1 minute

  • Hospital Anxiety and Depression Scale (HAD)

    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.

  • +1 more secondary outcomes

Study Arms (2)

Morning group

OTHER

Endurance and muscular exercise can be performed in the morning, either at 9:00am or 9:45am, or vice versa.

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.

Other: Pulmonary rehabilitation

Interventions

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

Afternoon groupMorning group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- cardiovascular contraindications to exercise
  • unstable respiratory status (uncompensated respiratory acidosis)
  • conditions interfering with the pulmonary rehabilitation process (progressive neuromuscular disease, psychiatric illness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique la Mitterie

Lille, 59130, France

RECRUITING

MeSH Terms

Conditions

Respiratory Tract DiseasesPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Michaël RACODON, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of clinical research

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 15, 2024

Study Start

January 2, 2024

Primary Completion

January 2, 2024

Study Completion (Estimated)

July 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations