Early Incentive and Mobilization During COPD Exacerbation (TIME)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hospital and home exercise training
Usual care
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease
Eligibility 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.
Sites / Locations
- Hospital de Sabadell
- Hospital Clinic i Provincial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Hospital and home exercise training
Usual care
Arm Description
Usual care plus hospital exercise training (aerobic and strength) followed by exercise training at home until 30 days to discharge.
Usual care in COPD
Outcomes
Primary Outcome Measures
Daily physical activity
Increase 10% moderate and/or vigorous daily physical activities after discharge
Secondary Outcome Measures
Tolerance to exercise
Six minutes walk test
COPD Assessment Test (CAT)
Quality of life
Physical activity
International Physical Activity Questionnaire (IPAQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01871025
Brief Title
Early Incentive and Mobilization During COPD Exacerbation
Acronym
TIME
Official Title
Early Incentive and Mobilization During COPD Exacerbation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hospital and home exercise training
Arm Type
Experimental
Arm Description
Usual care plus hospital exercise training (aerobic and strength) followed by exercise training at home until 30 days to discharge.
Arm Title
Usual care
Arm Type
Other
Arm Description
Usual care in COPD
Intervention Type
Other
Intervention Name(s)
Hospital and home exercise training
Intervention Description
Hospital exercise training (aerobic and strength) followed by exercise training
Intervention Type
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
Usual recommendations
Intervention Description
Usual care includes respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations, but not exercise training
Primary Outcome Measure Information:
Title
Daily physical activity
Description
Increase 10% moderate and/or vigorous daily physical activities after discharge
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Tolerance to exercise
Description
Six minutes walk test
Time Frame
1 month
Title
COPD Assessment Test (CAT)
Description
Quality of life
Time Frame
1 month
Title
Physical activity
Description
International Physical Activity Questionnaire (IPAQ)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Rodriguez, MD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Sabadell
City
Sabadell
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Early Incentive and Mobilization During COPD Exacerbation
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