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

University Hospital, Lille

Status: Terminated

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Center respiratory rehabilitation; Other: Home respiratory rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03453606

2017_08

2017-A02393-50 (Other Identifier)

PREPS-16-249 (Other Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

home group

Active Comparator group

Treatment:

Other: Home respiratory rehabilitation

center group

Active Comparator group

Treatment:

Other: Center respiratory rehabilitation