Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01826682
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Physiotherapy program+medical treatment Other: Medical treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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.
Other Names:
  • Physiotherapy
  • Respiratory exercises
  • Strength exercises




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Spain
Faculty of Health Sciences. University of Granada.
Granada., Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Investigators
Layout table for investigator information
Principal Investigator: Marie Carmen Valenza, PT, PhD Universidad de Granada
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marie Carmen Valenza, Assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01826682    
Other Study ID Numbers: DF0039UG
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marie Carmen Valenza, Universidad de Granada:
COPD, physiotherapy, exacerbation
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases