Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— REHABDO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03453606
• Other study ID #: 2017_08
• Secondary ID: 2017-A02393-50PR
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2018
• Est. completion date: January 2022

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: Olivier Le rouzic, MD,PhD
• Phone: 3.20.44.59.48
• Email: olivier.lerouzic[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 670
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Centre hospitalier de béthune	Béthune
France	CH de Béthune	Béthune
France	Hôpital Calmette, CHU	Lille
France	CH de Loos	Loos
France	CH Victor Provot, Roubaix	Roubaix
France	CH de Tourcoing	Tourcoing
France	CH de Wattrelos	Wattrelos

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center		Baseline
Secondary	Cost of interventions: respiratory rehabilitation in center or at home		At 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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