Clinical trial NCT01826682: Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease
Official title: Physiotherapy Program Intervention in Exacerbation of Chronic Obstructive Pulmonary Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, physiotherapy, exacerbation
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Strength in upper and lower limbs
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Changes in quality of life
timeFrame: baseline, 12 months
measure: Respiratory parameters
timeFrame: baseline, 12 months
measure: Activity monitoring
timeFrame: baseline
measure: Performance of Physical activity
timeFrame: baseline
measure: Changes in quality of sleep
timeFrame: baseline, 12 months
measure: Changes in anxiety and depression
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Granada.
country: Spain
facility: Faculty of Health Sciences. University of Granada.
state: Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torres-Sanchez I, Valenza MC, Cabrera-Martos I, Lopez-Torres I, Benitez-Feliponi A, 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. 2017 Feb;14(1):37-42. doi: 10.1080/15412555.2016.1209476. Epub 2016 Aug 11.
citation: Valenza MC, Valenza-Pena G, Torres-Sanchez I, Gonzalez-Jimenez E, Conde-Valero A, Valenza-Demet G. Effectiveness of controlled breathing techniques on anxiety and depression in hospitalized patients with COPD: a randomized clinical Trial. Respir Care. 2014 Feb;59(2):209-15. doi: 10.4187/respcare.02565. Epub 2013 Jul 23.