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Early Incentive and Mobilization During COPD Exacerbation (TIME)

This study is currently recruiting participants.
Verified September 2017 by Diego Agustín Rodríguez, Parc de Salut Mar
Sponsor:
ClinicalTrials.gov Identifier:
NCT01871025
First Posted: June 6, 2013
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Diego Agustín Rodríguez, Parc de Salut Mar
  Purpose
To study the effects of early exercise training in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). Interventions are randomized. In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 90 days to discharge and in the other the intervention is usual care. In both group, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the presence of a new COPD exacerbation according to Global Initiative for COPD (GOLD guidelines) with a minimum of 12 months-follow up.

Condition Intervention
Chronic Obstructive Pulmonary Disease Other: Hospital and home exercise training Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Incentive and Mobilization During COPD Exacerbation

Resource links provided by NLM:


Further study details as provided by Diego Agustín Rodríguez, Parc de Salut Mar:

Primary Outcome Measures:
  • Acute exacerbations [ Time Frame: 12 months ]
    Number of episodes of acute exacerbations defined as a sustained worsening of the patient's symptoms from their usual stable state which is beyond normal day-to-day variations, and is acute in onset. Symptoms included: worsening breathlessness, cough, increased sputum production and change in sputum colour


Secondary Outcome Measures:
  • Number of hospitalization [ Time Frame: 12 monhs ]
    Number of hospitalization due to acute exacerbations or other causes

  • Tolerance to exercise [ Time Frame: 12 months ]
    Six minutes walk test

  • Quality of life [ Time Frame: 12 months ]
    COPD Assessment Test (quality of life)

  • Physical activity [ Time Frame: 12 months ]
    International Physical Activity Questionnaire (IPAQ)

  • Length of hospitalization [ Time Frame: 12 monhs ]
    Number of days in each hospitalization


Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hospital and home exercise training
Usual care plus hospital exercise training (aerobic and strength) followed by exercise training at home until 90 days to discharge.
Other: Hospital and home exercise training
Hospital exercise training (aerobic and strength) followed by exercise training
Usual care
Usual care in COPD
Other: Usual care
Usual care includes respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations, but not exercise training
Other Name: Usual recommendations

Detailed Description:
Prospective randomized study in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 90 days to discharge and in the other the intervention is usual care. In both group, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the presence of a new COPD exacerbation according to Global Initiative for COPD (GOLD guidelines) with a minimum of 12 months-follow up.
  Eligibility

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patients for COPD exacerbation

Exclusion Criteria:

  • Hospitalization within the previous 14 days,
  • current participation in rehabilitation program,
  • locomotor or neurological condition or disability limiting the ability to perform exercise,
  • lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.
  Contacts and Locations
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): NCT01871025


Contacts
Contact: Diego Rodriguez, MD +34932483056 darodriguez@parcdesalutmar.cat
Contact: Esther Marco, MD +34699706860 emarco@parcdesalutmar.cat

Locations
Spain
Hospital de Cruces Not yet recruiting
Baracaldo, Spain, 48992
Contact: Juan Galdiz, MD    +3494603429    juanbautista.galdiziturri@osakidetza.net   
Principal Investigator: Juan Galdiz, MD         
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Diego Rodriguez, MD    +34932483056    darodriguez@parcdesalutmar.cat   
Contact: Esther Marco, MD    +34699706860    emarco@parcdesalutmar.cat   
Principal Investigator: Diego Rodriguez, MD         
Sub-Investigator: Esther Marco, MD         
Hospital Universitario de Gran Canaria Dr. Negrín Not yet recruiting
Las Palmas de Gran Canaria, Spain, 35017
Contact: Daniel Lopez Fernandez, MD    +34928352293    dlopfer@gobiernodecanarias.org   
Principal Investigator: Daniel López Fernandez, MD         
Hospital Universitario Central de Asturias Not yet recruiting
Oviedo, Spain, 33006
Contact: Almudena García García, MD    +34985107927    almugaga@hotmail.com   
Principal Investigator: Almudena Garcia Garcia, MD         
Hospital Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain, 41004
Contact: Maria del Pilar Cejudo, MD    +34955012214    mariap.cejudo.sspa@juntadeandalucia.es   
Principal Investigator: Maria del Pilar Cejudo, MD         
Hospital Universitario Virgen de la Macarena Not yet recruiting
Sevilla, Spain, 41009
Contact: Teodoro Montemayor, MD    +34630729226    teodoro.montemayor@gmail.com   
Principal Investigator: Teodoro Montemayor, MD         
Sponsors and Collaborators
Parc de Salut Mar
Investigators
Principal Investigator: Diego Rodriguez, MD Parc de Salut Mar
  More Information

Responsible Party: Diego Agustín Rodríguez, MD, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01871025     History of Changes
Other Study ID Numbers: 2012/4025
First Submitted: June 4, 2013
First Posted: June 6, 2013
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Diego Agustín Rodríguez, Parc de Salut Mar:
Chronic obstructive pulmonary disease

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