Overview

This trial is active, not recruiting.

Condition copd
Treatments physiotherapy program, medical standard treatment
Sponsor Universidad de Granada
Start date May 2015
End date March 2016
Trial size 60 participants
Trial identifier NCT02515318, DF0056UG

Summary

Chronic Obstructive Pulmonary Disease (COPD) is projected to be the fifth leading burden of disease worldwide by the year 2020. An acute exacerbation of COPD (AECOPD) is defined as an acute event characterized by a worsening of the patient's respiratory symptoms that requires a modification in the medication. AECOPD are frequent (mean of 1-4 exacerbations each year). It increases in frequency with the severity of the disease. The objective of this study is to examine whether a physical therapy intervention can reduce impairment in patients with COPD during hospitalization due to an acute exacerbation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Patients with COPD are included in this group. They will receive a physiotherapy program during the hospitalization due to acute exacerbation of COPD, additionally to the standard medical treatment
physiotherapy program Respiratory exercises
The physiotherapy treatment will be performed during the hospitalization, every day during 45-60 minutes, and included: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.
(Active Comparator)
Patients with COPD are included in this group. They will receive the medical standard treatment during the hospitalization due to acute exacerbation of COPD.
medical standard treatment Drugs
The standard medical treatment consists on: Inhaled bronchodilators: Short acting inhaled β2 agonists ( salbutamol and terbutaline) and anticholinergic agents (ipratropium and oxitropium bromide). Glucocorticoids: Inhaled glucocorticoids including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate and triamcinolone acetonide, depending on the expert criteria. - Antibiotics: The antibiotics were administered according to the GOLD criteria including the β‐lactamase inhibitor and fluoroquinolones.

Primary Outcomes

Measure
Muscle strength
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Exercise capacity
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.

Secondary Outcomes

Measure
Respiratory function
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Dyspnea
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Quality of life
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Fatigue
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Impact of COPD
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - COPD diagnosis with exacerbation. - No contraindication of physiotherapy. - Signed written consent. - Medical approval for inclusion Exclusion Criteria: - Neurological, orthopedic or heart diseases. - Prosthetic devices in the lower limbs.

Additional Information

Official title Effects of a Physiotherapy Program in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Principal investigator Marie Carmen Valenza, PhD
Description Chronic obstructive pulmonary disease (COPD) is one of the leading diseases causing mortality and morbidity, despite advanced pharmacotherapy and therapeutic management. COPD patients suffer frequent exacerbations, defined as 'acute events characterized by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication'. Acute illness and prolonged bed rest are associated with loss of muscle mass and a significant decline in functional ability and mobility. Interventions to counteract these impairments are indicated.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Universidad de Granada.