Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease

NCT03453606 | Terminated

• 3 other identifiers: 2017_082017-A02393-50PREPS-16-249
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 7

Brief Summary

The aim of this clinical trial is to establish the non-inferiority of home-based respiratory rehabilitation compared to respiratory rehabilitation in center in terms of exercise tolerance as evaluated by the 6 minutes Stepper test.. This trial will also 1°) evaluate the Medico-economic aspects of the home-based Respiratory rehabilitation versus respiratory Rehabilitation in center; 2°) analyse the patient preferences between home-based respiratory rehabilitation and respiratory rehabilitation in center and 3°) Compare home-based respiratory rehabilitation vs respiratory rehabilitation in center in terms of dyspnea, quality of life, anxiety and depression.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary rehabilitation; home-based

Outcome Measures

Primary Outcomes (1)

• Change from baseline the 6 minutes Stepper test at 2 months

  The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes

  At 2 months

Secondary Outcomes (7)

• Change from baseline the 6 minutes Stepper test at 6 and 12 months

  at 6 months, at12 months

• Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center

  Baseline

• Cost of interventions: respiratory rehabilitation in center or at home

  At 12 months

• Change from Baseline COPD Assessment Test (CAT) at 2,6,12 months

  baseline, after RR (2 months); 6 months and12 months

• Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months

  baseline, after RR (2 months); 6 months and12 months

Study Arms (2)

home group

ACTIVE COMPARATOR

Other: Home respiratory rehabilitation

center group

ACTIVE COMPARATOR

Other: Center respiratory rehabilitation

Interventions

Home respiratory rehabilitation OTHER

Home care is individual (often with the spouse or the carer), during 1h30, one visit per week for 8 weeks, after completion of the educational diagnosis, under direct supervision of a member of the team, with continued physical activities in autonomy the others days of the week, according to a personalized action plan. No visit is scheduled in the pulmonologist, the general practitioner or in the rehabilitation center. The team includes pulmonologist, nurses, dietician, socio-medical beautician and a administrative assistant.

home group

Center respiratory rehabilitation OTHER

In an outpatient setting, the course is performed in groups of 6 to 8 patients, during sessions from 3 to 7 am, under the direction of health professionals, 3 to 5 times a week, for 4 to 6 weeks, for a total of 20 to 24 sessions. Internally, patients come to "complete" hospitalization for 4 weeks. This duration can be modulated according to the evolution of the patients. Supervision is carried out by the entire team including pulmonologists, nurses, physiotherapists, psychologists, activity professors adapted physicists, dietician

center group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• According to the recommendations, HAS, SPLF, ERS / ATS will not be included any patient having :
• co-morbidities including unstabilized cardiovascular disease,
• significant cognitive disorders: patients with a history of pathologies neurodegenerative with loss of mental faculties (example: Alzheimer)
• psychiatric disorders: patients with impaired judgment and perception
• neurological or orthopedic disorders that do not allow the realization of physical activities
• Also, will not be included, the patient (s):
• waiting for lung transplantation,
• pregnant or nursing,
• in an emergency situation
• unable to receive enlightened information,
• unable to participate in the entire study,
• not covered by the social security scheme,
• refusing to sign the consent,

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (7)

Centre hospitalier de béthune

Béthune, France

Location

CH de Béthune

Béthune, France

Location

Hôpital Calmette, CHU

Lille, France

Location

CH de Loos

Loos, France

Location

CH Victor Provot, Roubaix

Roubaix, France

Location

CH de Tourcoing

Tourcoing, France

Location

CH de Wattrelos

Wattrelos, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier Le Rouzic, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 5, 2018
• Study Start: October 24, 2018
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

FR (7)