COPD Clinical Trial
Official 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"
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
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