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Completed

NCT Number: NCT01871025

Early Incentive and Mobilization During COPD Exacerbation

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.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Sabadell, Sabadell, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hospital and home exercise training

Other

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

Usual Care

Other

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

Other names: Usual recommendations

Primary outcomes

  1. Daily physical activity

    Time frame: 1 month

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

Secondary outcomes

  1. Tolerance to exercise

    Time frame: 1 month

    Six minutes walk test

  2. COPD Assessment Test (CAT)

    Time frame: 1 month

    Quality of life

  3. Physical activity

    Time frame: 1 month

    International Physical Activity Questionnaire (IPAQ)

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Acronym: TIME

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2013
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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