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

NCT03247933 | Completed

• 1 other identifier: TELEREHAB
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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).

Conditions

COPD

Keywords

COPD; RESPIRATORY REHABILITATION TELEMEDICINE

Outcome Measures

Primary Outcomes (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

  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 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)

  One year

Other Outcomes (1)

• Exploratory objective : To assess the cost effectiveness of the experimental strategy vs the usual approach (Time frame One year)

  Two Years

Study Arms (2)

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 .

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.

Interventions

Telemedicine: Maintenance Respiratory Rehabilitation DEVICE

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.

Telemedicine (TeleRR)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JUAN B GALDIZ ITURRI: lead
• Instituto de Salud Carlos III: collaborator
• Hospital de Cruces: collaborator

Study Sites (1)

Cruces University Hospital, Biocruces Institute

Barakaldo, Bizkaia, 48903, Spain

Location

Related Publications (1)

• 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.

  PMID: 32439253 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JUAN B GALDIZ ITURRI, PhD

  Cruces University Hospital, Biocruces Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Coded databases
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD- Neumologist

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: August 14, 2017
• Study Start: October 1, 2014
• Primary Completion: February 24, 2017
• Study Completion: February 24, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)