Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease

November 2, 2016 updated by: Marie Carmen Valenza, Universidad de Granada

Physiotherapy Program Intervention in Exacerbation of Chronic Obstructive Pulmonary Disease.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Granada
      • Granada., Granada, Spain, 18071
        • Faculty of Health Sciences. University of Granada.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 12 months
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)
baseline, 12 months
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.
baseline
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.
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.
baseline, 12 months
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.
baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Investigators

  • Principal Investigator: Marie Carmen Valenza, PT, PhD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF0039UG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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