Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease

Overview

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.

Full Title of Study: “Respiratory Rehabilitation at Home vs in the Center for Patients With Chronic Obstructive Pulmonary Disease: Efficacy, Preferences and Costs”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2022

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.

Interventions

  • 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.
  • 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

Arms, Groups and Cohorts

  • Active Comparator: home group
  • Active Comparator: center group

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change from baseline the 6 minutes Stepper test at 6 and 12 months
    • Time Frame: at 6 months, at12 months
    • The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes
  • Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center
    • Time Frame: Baseline
  • Cost of interventions: respiratory rehabilitation in center or at home
    • Time Frame: At 12 months
  • Change from Baseline COPD Assessment Test (CAT) at 2,6,12 months
    • Time Frame: baseline, after RR (2 months); 6 months and12 months
    • The COPD assessment test (CAT) is a short questionnaire initially intended for assess quality of life and clinical impact of COPD
  • Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months
    • Time Frame: baseline, after RR (2 months); 6 months and12 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.
  • Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months
    • Time Frame: Baseline, after RR (2 months); 6 months and12 months
    • To determine the levels of anxiety and depression that a COPD patients are experiencing
  • EPICES score
    • Time Frame: baseline
    • 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)

Participating in This Clinical Trial

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,

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Olivier Le Rouzic, MD,PhD, Principal Investigator, University Hospital, Lille
  • Overall Contact(s)
    • Olivier Le rouzic, MD,PhD, 3.20.44.59.48, olivier.lerouzic@chru-lille.fr

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