Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Physiotherapy Program Intervention in Exacerbation of Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826682
• Other study ID #: DF0039UG
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: November 2, 2016
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2016
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Chronic Obstructive Pulmonary Disease (COPD) is a chronic condition. Its evolution can be aggravated in some periods by an increase of the symptoms (above all the cough, the dyspnoea and the quantity of sputum purulence). This is known as exacerbation and it is the most frequent cause of hospital stay, urgences services and death in COPD. A physiotherapy program is carrying out in patients attending to the Hospital because of an exacerbation.

The hypothesis of this study is that a physiotherapy program added to a medical treatment increase the ventilatory function, the physiques variables, decrease depression and anxiety and improve the quality of life. Additionally, it is going to be assessed the effect of physiotherapy in time using phone calls and visits to the patient's home.

Description:

The benefits added to the respiratory physiotherapy and physical activity have been evidenced previously in the treatment of COPD. This justify the need of a short physiotherapy intervention program regarding to the hospital stay in exacerbation of COPD and a follow-up after the hospital stay.

4% of europeans have been reported to have medical intervention caused by respiratory exacerbation. 20% of these patients are patients with COPD. The mortality of COPD exacerbation is about 14% and 30% if mechanical ventilation is needed.

In order to that, it is very important to improve the quality of life and the recuperation of patients. It is relevant to mention the the high cost associated to this condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD diagnosis with exacerbation.

• No contraindication of physiotherapy.

• Signed written consent.

• Medical approval for inclusion.

Exclusion Criteria:

• Heart disease.

• Neurological patients.

• Contraindications of physiotherapy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Physiotherapy program+medical treatment
Patients included in this group are going to receive physiotherapy during their hospital stay 45 minutes every day. The physical training is based on respiratory exercises, the use of a flutter (positive expiratory pressure), pedaling and theraband exercises.
• Medical treatment
Standard medical treatment without physiotherapy.

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences. University of Granada.	Granada.	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Torres-Sánchez I, Valenza MC, Cabrera-Martos I, López-Torres I, Benítez-Feliponi Á, Conde-Valero A. Effects of an Exercise Intervention in Frail Older Patients with Chronic Obstructive Pulmonary Disease Hospitalized due to an Exacerbation: A Randomized Controlled Trial. COPD. 2016 Aug 11:1-6. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strength in upper and lower limbs	Changes from baseline to postintervention during hospital stay in lower and upper limbs strength. The quadriceps and the hand-grip strength is assessed using a dynamometer with a standard protocol allowing three attempts on each side. During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°. The maximum value achieved was used in the analyses. This is important in order to quantify the increase of strength Kg/cm2 The test 2-minute step in place is also going to be used for this purpose, counting the times the patients go up the right knees in two minutes.	baseline, 12 months	Yes
Secondary	Changes in quality of life	Changes from baseline to postintervention during hospital stay in quality of life associated with health. This is going to be measure with two questionnaires: the EuroQol-5 questionnaire and the Health Questionnaire St. George	baseline, 12 months	Yes
Secondary	Respiratory parameters	Changes from baseline to postintervention in respiratory parameters using a spirometer as recommended by the American Thoracic Society. The most important respiratory parameters evaluated are forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), carbon dioxide partial pressure (PCO2) and oxygen partial pressure (PO2)	baseline, 12 months	Yes
Secondary	Activity monitoring	The accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours.	baseline	Yes
Secondary	Performance of Physical activity	The participants are going to complete the Baecke physical activity questionnaire-modified in order to describe their physical status at baseline.	baseline	Yes
Secondary	Changes in quality of sleep	Changes in quality of sleep from baseline to postintervention. For this purpose, the participants are going to complete the Pittsburgh Quality of Sleep Index. This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.	baseline, 12 months	Yes
Secondary	Changes in anxiety and depression	Changes from baseline to postintervention in anxiety and depression measured with the Hospital Anxiety and Depression Scale. Patients are going to completed this questionnaire composed of statements relevant to either generalised anxiety or depression.	baseline, 12 months	Yes