COPDTELEREHABNCT03247933
TELEMEDICINE,Maintenance of a Respiratory Rehabilitation Program in Patients With Chronic Obstructive Pulmonary Disease.
A study testing Telemedicine: Maintenance Respiratory Rehabilitation in people with COPD, run by JUAN B GALDIZ ITURRI at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Telemedicine: Maintenance Respiratory Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to 24 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with COPD
- age 8 and 75 (both included)
- index BODE's 3-7 ( BODE Iindex for Body-mass index, airflow Obstruction, Dyspnea, and Exercise)
- 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
- has given his consent
- capable of using 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: 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
Who cannot join
- Osteo-muscular pathology that limit or preclude the exercises
- Presence of heart disease which limit exercise program
- patients with bronchiectasis or other several of COPD respiratory disorders
- comorbidity that prevent 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 study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Cruces University Hospital, Biocruces Institute
Barakaldo, Bizkaia, 48903
About this study
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.
Read more
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).
Read the detailed description
- 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
- 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.
- Education: 4 sessions on knowledge of the disease and medication management learning.
- General physiotherapy: teach to make the diaphragmatic breathing, drainage of secretions (if applicable) and relaxation techniques.
- 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
- Conditions
- COPD
- Being tested
- Telemedicine: Maintenance Respiratory Rehabilitation
- Keywords
- COPD, RESPIRATORY REHABILITATION TELEMEDICINE
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine: Maintenance Respiratory RehabilitationDevice
Telemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance respiratory rehabilitation supported by telemedicine (TeleRR).
A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year.
They will be in their homes doing the program of treatment prescribed by the physician. They will be provided with the material that is needed: 1 static bicycle, 2-weights / cufflinks, 3-device mobile (smartphone/PDA) + Pulse Oximeter.
The patient must send the exercises every day that are scheduled training exercises once have been completed.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine (TeleRR) | Experimental | The intervention: Telemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance Respiratory Rehabilitation supported by telemedicine (TeleRR).
A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year.
The exercises dates must be sent after doing the training each day by the PDA . The dates will be monitoring by the physician . Receives: Device: Telemedicine: Maintenance Respiratory Rehabilitation |
| Clinical Practice (Recommendation) | No intervention | No intervention. A recommendation from standard maintenance respiratory rehabilitation program with a minimum monitoring. Clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: One Year
Secondary outcomes (1)
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study startOct 2014
- Primary completion24 Feb 2017
- Study completion24 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- JUAN B GALDIZ ITURRI
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Hospital de Cruces
- Responsible party
- Sponsor-investigator, JUAN B GALDIZ ITURRI, Hospital de Cruces
- Investigators
- JUAN B GALDIZ ITURRI, PhD, Study chair, Cruces University Hospital, Biocruces Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247933
- Sponsor's protocol ID
- TELEREHAB
- Acronym
- TELEREHAB
- Status last verified
- Aug 2017
- First submitted
- 15 Sep 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Galdiz JB, Gomez A, Rodriguez D, Guell R, Cebollero P, Hueto J, Cejudo P, Ortega F, Sayago I, Chic S, Iscar M, Amado C, Rodriguez Trigo G, Cosio BG, Bustamante V, Pijoan JI. Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial. Arch Bronconeumol (Engl Ed). 2021 Mar;57(3):195-204. doi: 10.1016/j.arbres.2020.03.034. Epub 2020 May 19. English, Spanish.
PubMed 32439253
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03247933
- Acronym / sponsor ID
- TELEREHAB / TELEREHAB
- Conditions
- COPD
- Keywords
- COPD, RESPIRATORY REHABILITATION TELEMEDICINE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- JUAN B GALDIZ ITURRIUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Hospital de Cruces
- Study start
- Oct 2014
- Primary completion
- 24 Feb 2017 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- 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
- 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.
- Education: 4 sessions on knowledge of the disease and medication management learning.
- General physiotherapy: teach to make the diaphragmatic breathing, drainage of secretions (if applicable) and relaxation techniques.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine (TeleRR) | Experimental | Device: Telemedicine: Maintenance Respiratory RehabilitationThe intervention: Telemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance Respiratory Rehabilitation supported by telemedicine (TeleRR). A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year. The exercises dates must be sent after doing the training each day by the PDA . The dates will be monitoring by the physician . |
| Clinical Practice (Recommendation) | No intervention | –No intervention. A recommendation from standard maintenance respiratory rehabilitation program with a minimum monitoring. Clinical practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients with COPD
- age 8 and 75 (both included)
- index BODE's 3-7 ( BODE Iindex for Body-mass index, airflow Obstruction, Dyspnea, and Exercise)
- 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
- has given his consent
Key exclusion criteria (6 listed)
- Osteo-muscular pathology that limit or preclude the exercises
- Presence of heart disease which limit exercise program
- patients with bronchiectasis or other several of COPD respiratory disorders
- comorbidity that prevent respiratory rehabilitation of maintenance program
- less than 2 years life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine: Maintenance Respiratory RehabilitationTelemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance respiratory rehabilitation supported by telemedicine (TeleRR). A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year. They will be in their homes doing the program of treatment prescribed by the physician. They will be provided with the material that is needed: 1 static bicycle, 2-weights / cufflinks, 3-device mobile (smartphone/PDA) + Pulse Oximeter. The patient must send the exercises every day that are scheduled training exercises once have been completed. | Device | Telemedicine (TeleRR) |
Primary outcome
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
Time frame: One Year
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 .
1 secondary outcome
Specific objective: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] .Safety of TeleRehab (mortality an serious events due related to the program)
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Derived from this study: PubMed 32439253Galdiz JB, Gomez A, Rodriguez D, Guell R, Cebollero P, Hueto J, Cejudo P, Ortega F, Sayago I, Chic S, Iscar M, Amado C, Rodriguez Trigo G, Cosio BG, Bustamante V, Pijoan JI. Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial. Arch Bronconeumol (Engl Ed). 2021 Mar;57(3):195-204. doi: 10.1016/j.arbres.2020.03.034. Epub 2020 May 19. English, Spanish.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JUAN B GALDIZ ITURRI, PhD study chair
Cruces University Hospital, Biocruces Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine: Maintenance Respiratory Rehabilitation in people with COPD, run by JUAN B GALDIZ ITURRI at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03247933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.