Early Incentive and Mobilization During COPD Exacerbation

NCT01871025 | Completed

• 1 other identifier: 2012/4025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Daily physical activity

  Increase 10% moderate and/or vigorous daily physical activities after discharge

  1 month

Secondary Outcomes (3)

• Tolerance to exercise

  1 month

• COPD Assessment Test (CAT)

  1 month

• Physical activity

  1 month

Study Arms (2)

Hospital and home exercise training

EXPERIMENTAL

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

Usual care

OTHER

Usual care in COPD

Other: Usual care

Interventions

Hospital and home exercise training OTHER

Hospital exercise training (aerobic and strength) followed by exercise training

Hospital and home exercise training

Usual care OTHER

Usual care includes respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations, but not exercise training

Also known as: Usual recommendations

Usual care

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients for COPD exacerbation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (2)

Hospital de Sabadell

Sabadell, Barcelona, Spain

Location

Hospital Clinic i Provincial

Barcelona, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Hospitals

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Diego Rodriguez, MD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

ES (2)