Early Incentive and Mobilization During COPD Exacerbation (TIME)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Parc de Salut Mar
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01871025
First received: June 4, 2013
Last updated: June 5, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Parc de Salut Mar:

Primary Outcome Measures:
  • Acute exacerbations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of hospitalization due to acute exacerbations or other causes

  • Tolerance to exercise [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Six minutes walk test

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    COPD Assessment Test (quality of life)

  • Physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    International Physical Activity Questionnaire (IPAQ)

  • Length of hospitalization [ Time Frame: 12 monhs ] [ Designated as safety issue: No ]
    Number of days in each hospitalization


Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet 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

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01871025     History of Changes
Other Study ID Numbers: 2012/4025
Study First Received: June 4, 2013
Last Updated: June 5, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Parc de Salut Mar:
Chronic obstructive pulmonary disease

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

ClinicalTrials.gov processed this record on October 01, 2014