Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT01826682|
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : November 3, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: Physiotherapy program+medical treatment Other: Medical treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Physiotherapy Program Intervention in Exacerbation of Chronic Obstructive Pulmonary Disease.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||December 2014|
Placebo Comparator: Medical treatment
29 people are being recruited in order to the inclusion criteria for the study. Placebo controlled.
Other: Medical treatment
Standard medical treatment without physiotherapy.
Other Name: Drugs
Active Comparator: Physiotherapy program+medical treatment
29 people are recruited in order to the inclusion criteria for the study. Experimental group
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.
- Strength in upper and lower limbs [ Time Frame: baseline, 12 months ]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.
- Changes in quality of life [ Time Frame: baseline, 12 months ]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
- Respiratory parameters [ Time Frame: baseline, 12 months ]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)
- Activity monitoring [ Time Frame: baseline ]The accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours.
- Performance of Physical activity [ Time Frame: baseline ]The participants are going to complete the Baecke physical activity questionnaire-modified in order to describe their physical status at baseline.
- Changes in quality of sleep [ Time Frame: baseline, 12 months ]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.
- Changes in anxiety and depression [ Time Frame: baseline, 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826682
|Faculty of Health Sciences. University of Granada.|
|Granada., Granada, Spain, 18071|
|Principal Investigator:||Marie Carmen Valenza, PT, PhD||Universidad de Granada|