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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
First received
Last updated
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
Health authority
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,

Study Design


Related Conditions & MeSH terms


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
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