Early Incentive and Mobilization During COPD Exacerbation (TIME)

October 9, 2018 updated by: Diego Agustín Rodríguez, Parc de Salut Mar
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 30 days to discharge and in the other the intervention is usual care. In both groups, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the increase in moderate or vigorous daily physical activities at 30 days after discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 30 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 increase in moderate or vigorous daily physical activities at 30 days after discharge.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Clinic I Provincial
    • Barcelona
      • Sabadell, Barcelona, Spain
        • Hospital de Sabadell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hospital and home exercise training
Usual care plus hospital exercise training (aerobic and strength) followed by exercise training at home until 30 days to discharge.
Other: Hospital and home exercise training
Hospital exercise training (aerobic and strength) followed by exercise training
Other: 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 Names:
  • Usual recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily physical activity
Time Frame: 1 month
Increase 10% moderate and/or vigorous daily physical activities after discharge
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance to exercise
Time Frame: 1 month
Six minutes walk test
1 month
COPD Assessment Test (CAT)
Time Frame: 1 month
Quality of life
1 month
Physical activity
Time Frame: 1 month
International Physical Activity Questionnaire (IPAQ)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Diego Rodriguez, MD, Parc de Salut Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/4025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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