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

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ClinicalTrials.gov Identifier: NCT03453606
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Home respiratory rehabilitation Other: Center respiratory rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Respiratory Rehabilitation at Home vs in the Center for Patients With Chronic Obstructive Pulmonary Disease: Efficacy, Preferences and Costs
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center [ Time Frame: Baseline ]
  3. Cost of interventions: respiratory rehabilitation in center or at home [ Time Frame: At 12 months ]
  4. 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

  5. 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.

  6. 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

  7. 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)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453606


Contacts
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Contact: Olivier Le rouzic, MD,PhD 3.20.44.59.48 ext +33 olivier.lerouzic@chru-lille.fr
Contact: Benoit Wallaert, MD,PhD

Locations
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France
Centre hospitalier de béthune Recruiting
Béthune, France
Principal Investigator: Frédéric Bart, MD         
Hôpital Calmette, CHU Recruiting
Lille, France
Principal Investigator: Olivier Le Rouzic, MD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Olivier Le Rouzic, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03453606     History of Changes
Other Study ID Numbers: 2017_08
2017-A02393-50 ( Other Identifier: ID-RCB number, ANSM )
PREPS-16-249 ( Other Identifier: PREPS number, DGOS )
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Pulmonary rehabilitation
home-based

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases