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Clinical Trials/NCT01826682
NCT01826682
Completed
Not Applicable

Physiotherapy Program Intervention in Exacerbation of Chronic Obstructive Pulmonary Disease.

Universidad de Granada1 site in 1 country58 target enrollmentMarch 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Universidad de Granada
Enrollment
58
Locations
1
Primary Endpoint
Strength in upper and lower limbs
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
December 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

Assistant professor

Universidad de Granada

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes in quality of sleep(baseline, 12 months)
  • Changes in anxiety and depression(baseline, 12 months)
  • Respiratory parameters(baseline, 12 months)
  • Activity monitoring(baseline)
  • Changes in quality of life(baseline, 12 months)
  • Performance of Physical activity(baseline)

Study Sites (1)

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