TELEMEDICINE,Maintenance of a Respiratory Rehabilitation Program in Patients With Chronic Obstructive Pulmonary Disease.
TELEMEDICINE,Maintenance of a Respiratory Rehabilitation Program in Patients With Chronic Obstructive Pulmonary Disease.
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).
1. SELECTION AND WITHDRAWAL OF SUBJECTS

 1.1 INCLUSION CRITERIA

 To be eligible to participate in this study, subjects must meet the following inclusion
 criteria:

 Patients diagnosed with COPD aged less than 75 years BODE index of 3-7 clinical
 stability, understood as not having an exacerbation (*) of the COPD and not require
 treatment with antibiotics, corticoids systemic and/or hospitalization, at least 1 month
 prior to inclusion in the study. You have been reported to the subject and has been
 given sufficient time and opportunity to consider their participation has given its
 consent in writing. Able to use technology 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:

 Increase in volume of sputum, sputum Purulence ,Dyspnea

 or

 • Worsening of any main symptom along with one of the following symptoms for at least 2
 consecutive days.

 -  Resfriado (rinorrea y/o congestión nasal)

 -  Fever without any other cause

 -  Cough

 -  Wheezing

 1.2 Exclusion criteria

 Patients who have any of the following exclusion criteria may not be included in the
 trial:

 • Presence of osteo-muscular pathology that limit or preclude the exercises. Presence of
 heart disease which hinders exercise. Patients with bronchiectasis or other respiratory
 disorders other than COPD. Comorbidity who hinders or blocks the making of respiratory
 rehabilitation of maintenance program. Less than 2 years life expectancy.

 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 same

 Withdrawal of subjects and procedures criteria

 Patients may leave the study at any time. Each month the researcher will check filling
 in each patient assigned to the experimental group respiratory rehabilitation program.
 If a patient does not fill this program for 2 consecutive months, excluding
 impossibility for clinical situation and medical criteria, will be removed from the
 study.

 In addition respiratory rehabilitation maintenance in both treatment groups will be
 suspended if any adverse events that justify it at the discretion of the investigator.

 If so, the follow-up of the patients will continue also to analyze the results according
 to an intention of treatment strategy.La retirada de los sujetos así como sus motivos
 quedará reflejada tanto en el historial clínico como en el cuaderno de recogida de
 datos.

 Any death that occurs during the performance of the EC must be notified immediately to
 the promoter and the competent Ethics Committee.

 Withdrawals of subjects is not replaced

 2. PROTOCOL TREATMENT

 The information sheet will be delivered to the patient all of those potentially eligible
 patients according to the inclusion criteria marked and no exclusion criteria (point 6) let
 them the time needed to read the document and make all ask them as necessary. If the patient
 decides to participate in the trial, it will ask you to sign the informed consent form.

 SELECTION VISIT

 This visit will include the test data for patients diagnosed with COPD, which includes:
 "history: on the scale of MRC Dyspnoea score" "physical examination: weight, height, body
 mass index, brachial perimeter crease triceps and quadriceps strength " X-ray of thorax and
 electrocardiogram respiratory function tests (spirometry, Lung volumes, transfer to CO,
 maximum respiratory pressure and blood gas capacity) maximum questionnaire of quality of
 life-related lower-limb exercise test with the Health: CRQ (self-administered version), and
 SF-36 test of 6 minutes 6 minutes walking test with assessment of breathlessness to the
 effort using the Borg scale at the beginning and at the end of six minutes the BODE index
 calculation test

 Criteria of Inclusion / Exclusion criteria, information to the patient and informed consent
 signature, indicating date

 On this visit the code of patient will be assigned to each of the patients who accept to
 participate in the trial and that sign the informed consent

 INTENSIVE REHABILITATION (RRi) (8 weeks- ± 4 days)

 Once signed the informed consent (CI) the patient will receive an initial program of
 intensive RR (hospital-based program standard according to usual practice) participate in
 this phase all the patients in the study and will receive equal treatment. This program will
 be taught in groups of 5 patients (approx) and will last a total of 8 weeks. Patients will
 have to go to the hospital 3 hours/d 3 days per week where respiratory rehabilitation program
 will be intensive.

 The program will include the following sections.

 1. Education: 4 sessions on knowledge of the disease and medication management learning.

 2. General physiotherapy: teach to make the diaphragmatic breathing, drainage of secretions
 (if applicable) and relaxation techniques.

 3. Muscle training:

 3.a.-upper extremity muscles: will be weight-bearing exercises. The initial charge will be
 500gr and will increase progressively depending on the tolerance of the patient. The training
 time will be 30 minutes.

 3.b.-lower extremity muscles: will be made with an antispasm. The initial charge will be 50%
 of the maximum load in the progressive stress test. The workload according to the tolerance
 of the patient will subsequently increase. The training time will be also of 30 minutes

 MAINTENANCE CALENDAR (Visits)

 RANDOMIZATION visit (V0) (assignment to the maintenance group)

 Once completed the intensive treatment of RR, that same day, all patients participating in
 the trial will be distributed randomly to one of the two groups of RR for maintenance
 treatment:

 -GR1 (TeleRR): will receive an RR of maintenance program with use of support for telemedicine
 (TeleRR) all of them will be prescribed treatment program at his own home by the doctor,
 initially very similar to the received in the hospital phase.

 Them will be provided the material for the realization of the programme of RR: exercise bike,
 weights / cufflinks mobile device (PDA/Smartphone) + Pulse Oximeter.

 You will indicate them to perform exercises prescribed by your doctor as treatment and that
 they complete training on the mobile device data. The patient should be sending the data of
 all the days that are scheduled training exercises once have been completed.

 -GR2 (control): receive a recommendation from a standard respiratory rehabilitation program
 with a minimum monitoring, similar to routine clinical practice.

 FOLLOW UP VISITS

 In total and after completion of the period of intensive RR, will be planned 3 follow-up
 visits that may be NO face-to-face or face-to-face and/or ON - LINE:

 Visit 1 - tracking: 3 months (± 1 week) after the last visit of randomization (V0).

 Visit 2 - follow-up: 9 months (± 2 weeks) after the last visit of randomization (V0).

 Visit 3 - follow-up: 12 months (± 2 weeks) after the last visit of randomization (V0), ending
 the involvement of the patient in the study

 NON FACE TO FACE MONITORING

 For all visits and patients the participants held a non-contact clinical follow-up through
 information systems corresponding in each of the participating centres. Information to pick
 up will be:

 If there has been a neglect of the RR maintenance, and if it was so, what have been the
 causes. If there is a hospital income since the last visit if there is an entry in the
 emergency room since the last visit If there are visits to unscheduled primary care by
 exacerbation

 FACE TO FACE VISITS

 In addition to tracking is not face-to-face, there will be a face-to-face follow-up
 extraordinary for participating in the trial and that will depend on the group that has been
 assigned the patient in which the following tests will be carried out:

 - Visit 1 -: 3 months (± 1 week) after the last visit of randomization (V0).

 Experimental Group GR1:

 -  Physical examination: weight, height and body mass index.

 -  Respiratory function tests (spirometry, Lung volumes, transfer to CO, maximum
 respiratory pressure and blood gas capacity) quality of life health-related
 questionnaires: CRQ (self-administered version), and SF-36

 -  Six minutes walking test, assessment of breathlessness to the effort using the Borg
 scale at the beginning and at the end of six minutes the BODE index calculation test and
 adverse events or adverse reactions that have been able to present during the period
 since the previous visit

 Visit 2 - follow-up: 9 months (± 2 weeks) after the last visit of randomization (V0):

 Experimental Group GR1 :

 Physical examination: weight, height and body mass index. Respiratory function tests
 (spirometry, Lung volumes, transfer to CO, maximum respiratory pressure and blood gas
 capacity) quality of life health-related questionnaires: CRQ (self-administered version), and
 SF-36 test of 6 minutes of the March assessment of breathlessness to the effort using the
 Borg scale at the beginning and at the end of six minutes the BODE index calculation test
 adverse events or adverse reactions that have been able to present during the period from the
 previous visit.

 Control Group GR2:

 • Quality of life health-related questionnaires: CRQ (self-administered version), and SF-36
 the 6-minute walking test

 - Visit 3 - follow-up: 12 months (± 2 weeks) after the last visit of randomization (V0),
 where there will be the following

 Both Groups GR1 and GR2:

 Physical examination: weight, height and body mass index. Respiratory function tests
 (spirometry, Lung volumes, transfer to CO, maximum respiratory pressure and blood gas
 capacity) quality of life health-related questionnaires: CRQ (self-administered version), and
 SF-36 6MWT, assessment of breathlessness to the effort using the Borg scale at the beginning
 and at the end of six minutes the BODE index calculation test and adverse events or adverse
 reactions that have been able to present during the period from the previous visit.

 ON-LINE FOLLOW UP

 Experimental Group GR1

 ONLY for patients in the Experimental group, there will be a monitoring On - Line monthly by
 filling in Telerhabilitacion RR program through the reception of data from the mobile device
 to the patient
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