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TELEMEDICINE,Maintenance of a Respiratory Rehabilitation Program in Patients With Chronic Obstructive Pulmonary Disease. (TELEREHAB)

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ClinicalTrials.gov Identifier: NCT03247933
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : August 30, 2017
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Hospital de Cruces
Information provided by (Responsible Party):
JUAN B GALDIZ ITURRI, Hospital de Cruces

Brief 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 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).


Condition or disease Intervention/treatment Phase
COPD Device: Telemedicine: Maintenance Respiratory Rehabilitation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Coded databases
Primary Purpose: Treatment
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"
Study Start Date : October 2014
Actual Primary Completion Date : February 24, 2017
Actual Study Completion Date : February 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Telemedicine (TeleRR)

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 .

Device: Telemedicine: Maintenance Respiratory Rehabilitation

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.


No Intervention: Clinical Practice (Recommendation)

No intervention. A recommendation from standard maintenance respiratory rehabilitation program with a minimum monitoring.

Clinical practice.




Primary Outcome Measures :
  1. 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 .



Secondary Outcome Measures :
  1. 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 ]
    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


Other Outcome Measures:
  1. Exploratory objective : To assess the cost effectiveness of the experimental strategy vs the usual approach (Time frame One year) [ Time Frame: Two Years ]
    Exploratory objective : Evaluate the efficiency between the usual approach and experimental strategy (including the TeleRR program) doing an analysis cost effectiveness



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247933


Locations
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Spain
Cruces University Hospital, Biocruces Institute
Barakaldo, Bizkaia, Spain, 48903
Sponsors and Collaborators
JUAN B GALDIZ ITURRI
Instituto de Salud Carlos III
Hospital de Cruces
Investigators
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Study Chair: JUAN B GALDIZ ITURRI, PhD Cruces University Hospital, Biocruces Institute

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Responsible Party: JUAN B GALDIZ ITURRI, PhD- Neumologist, Hospital de Cruces
ClinicalTrials.gov Identifier: NCT03247933     History of Changes
Other Study ID Numbers: TELEREHAB
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by JUAN B GALDIZ ITURRI, Hospital de Cruces:
COPD
RESPIRATORY REHABILITATION TELEMEDICINE

Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases