COPD Clinical Trial
— TELEREHABOfficial title:
"Clinical Trial Randomized, Controlled, Parallel-group and Open About the Use of"TELEMEDICINE"in the Management of the Maintenance of a Respiratory Rehabilitation Program Phase in Patients With Chronic Respiratory Diseases"
Verified date | August 2017 |
Source | Hospital de Cruces |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Respiratory rehabilitation (RR) has been shown to provide benefits in patients with Chronic
Obstructive Pulmonary Disease (COPD) with a degree of evidence A.
These benefits are primarily focused on an increase in the capacity of effort for activities
of daily living and in an improvement in the quality of life related to health (HRQOL) a
constant to the RR critique is the fact that the benefits achieved with programmes are lost
in a progressive and constant way once the patient completes the treatment and lost contact
with the team.
The introduction of new technologies in different fields of medicine has been a new approach
when it comes to the management of various diseases and treatments in chronic patients. In
the case of the RR telemedicine provides a new tool.
COPD disease very prevalent and chronic it is generator of a high economic cost. The
possibility of universalizing the rehabilitation treatment would involve a potential savings
in this population group ,another potential benefit is as translational trial as part of the
development of a new technology and its possible application to clinical practice.
General objective: to determine whether a program of TeleRehabilitation (TeleRR)- Respiratory
Rehabilitation Maintenance (RRm) after an intensive initial program of RR, is a useful
intervention against the current usual strategy (intensive program of RR and a recommendation
of not protected maintenance program).
Method: clinical trial , open, randomized, multicenter, parallel group, and focus of
superiority with a strategy of Telerehabilitation program respiratory of maintenance after an
intensive RR for 8 weeks in patients diagnosed with grade moderately - severe stable COPD
(Bode 3-7).
Status | Completed |
Enrollment | 94 |
Est. completion date | February 24, 2017 |
Est. primary completion date | February 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. patients with COPD 2. age 8 and 75 (both included) 3. index BODE's 3-7 ( BODE Iindex for Body-mass index, airflow Obstruction, Dyspnea, and Exercise) 4. clinical stability, understood as not having an exacerbation (*) of the COPD and do not require treatment with antibiotics, corticoids systemic and/or hospitalization, at least in the 30 days prior to their inclusion 5. has given his consent 6. capable of using technology 7. the subject is willing and is able to meet all the requirements of the study. * Exacerbation : Exacerbation means worsening of two or more of the following main symptoms for at least 2 consecutive days: dyspnea, volume of sputum; Sputum purulence o worsening of any main symptom along with one of the following symptoms for at least 2 consecutive days: sore throat; Cold ( nasal congestion); Fever without any other cause; Cough; Wheezing Exclusion Criteria: 1. Osteo-muscular pathology that limit or preclude the exercises 2. Presence of heart disease which limit exercise program 3. patients with bronchiectasis or other several of COPD respiratory disorders 4. comorbidity that prevent respiratory rehabilitation of maintenance program 5. less than 2 years life expectancy 6. any unstable medical or psychiatric process or substance abuse which, in the opinion of the investigator, would affect the ability of the patient to complete the study or impede their participation in the study |
Country | Name | City | State |
---|---|---|---|
Spain | Cruces University Hospital, Biocruces Institute | Barakaldo | Bizkaia |
Lead Sponsor | Collaborator |
---|---|
JUAN B GALDIZ ITURRI | Hospital de Cruces, Instituto de Salud Carlos III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory objective : To assess the cost effectiveness of the experimental strategy vs the usual approach (Time frame One year) | Exploratory objective : Evaluate the efficiency between the usual approach and experimental strategy (including the TeleRR program) doing an analysis cost effectiveness | Two Years | |
Primary | Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months | a).Effectiveness of an Tele Respiratory Rehabiltation program in the maintenance of benefits after an intensive respiratory rehabilitation. outcomes:A/ the distancecovered (meters) in the 6m Walking test B/ health quality questionnaires. Specific respiratory questionaire (CRQ); General questionaire (SF 36) after 12 months of maintenance program.C/Changes in the multidimensional scale BODE. TeleRR program is clinically effective in the medium and long term by keeping the initial benefits of the intensive RR in aspects such as the capacity of effort (distance in meters), HRQOL and BODE . |
One Year | |
Secondary | Specific objective: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] .Safety of TeleRehab (mortality an serious events due related to the program) | Safety of TeleRehab defined as directly events related with the program (Injury ,cardiac events, mortality and other events caused during the exercise program),data was recorded in the CRD | One year |
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