Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (REHABDO)

Respiratory Rehabilitation at Home vs in the Center for Patients With Chronic Obstructive Pulmonary Disease: Efficacy, Preferences and Costs

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Home respiratory rehabilitation; Other: Center respiratory rehabilitation

Detailed Description

The purpose of this study is to perform a comparative analysis of the clinical and medico-economic effectiveness of center-based RR versus home-based RR in the departments of Nord and Pas de Calais in France. All COPD patients eligible for RR and willing to participate in the study will be followed.

Patient preferences will be evaluated at inclusion. After presentation of both RR modalities, patients expressing a strong preference for one or other of the terms will be taken care of according to their wishes. Indifferent patients between the two RR modalities will be randomized.

This design is justified in the light of three cases:

• It is impossible to evaluate blind intervention,
• The effectiveness of RR depends on patient preferences,
• Patients' adherence to the protocol is facilitated.

• Study Type: Interventional
• Enrollment (Anticipated): 670
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Béthune, France
    • Recruiting
    • Centre Hospitalier de Béthune
    • Principal Investigator: Fréderic Bart, MD
  • Béthune, France
    • Recruiting
    • CH de Béthune
    • Principal Investigator: Fréderic Bart, MD
  • Lille, France
    • Recruiting
    • Hôpital Calmette, CHU
    • Principal Investigator: Olivier Le Rouzic, MD
  • Loos, France
    • Recruiting
    • CH de Loos
    • Principal Investigator: Said Benkharraz, MD
  • Roubaix, France
    • Recruiting
    • CH Victor Provot, Roubaix
    • Principal Investigator: François Steenhouwer, MD
  • Tourcoing, France
    • Recruiting
    • CH de Tourcoing
    • Principal Investigator: Thirard Laurence, MD
  • Wattrelos, France
    • Recruiting
    • CH de Wattrelos
    • Principal Investigator: Alain Strecker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:According to HAS recommendations, SPLF, ERS / ATS (3) (18) (19) can be included any patient, over 18 years old, with stage II - III - IV COPD presenting disabling dyspnoea in activities of daily living, and / or in the course of acute exacerbation of COPD (EABPCO), with no other respiratory pathology diagnosed.

Exclusion Criteria:

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,

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: home group	Other: Home respiratory rehabilitation; 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.
Active Comparator: center group	Other: Center respiratory rehabilitation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline the 6 minutes Stepper test at 6 and 12 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 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	The COPD assessment test (CAT) is a short questionnaire initially intended for assess quality of life and clinical impact of COPD	baseline, after RR (2 months); 6 months and12 months
Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months	The scale measures a person's limitation base on a scale of 0-4 and uses the final value to determine how much disability is caused by shortness of breath.Five-option grading system called the Modified Medical Research Council (MMRC) Dyspnea Scale.	baseline, after RR (2 months); 6 months and12 months
Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months	To determine the levels of anxiety and depression that a COPD patients are experiencing	Baseline, after RR (2 months); 6 months and12 months
EPICES score	EPICES score (Assessment of the precariousness and health inequalities in the Health Examination Centers, French) is an individual indicator of precariousness ,Self-administered questionnaire,quantify the level of social vulnerability and precariousness. It ranges from zero (no vulnerability) to 100 (maximum vunerability)	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Olivier Le Rouzic, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Pulmonary rehabilitation; home-based
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2017_08; 2017-A02393-50 (Other Identifier: ID-RCB number, ANSM); PREPS-16-249 (Other Identifier: PREPS number, DGOS)

Drug and device information, study documents

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