Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Physiotherapy Program Intervention in Exacerbation of Chronic Obstructive Pulmonary Disease.
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Health Sciences. University of Granada. | Granada. | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada |
Spain,
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
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 |
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