Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease

NCT ID: NCT01826682

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD, physiotherapy, exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Medical treatment

29 people are being recruited in order to the inclusion criteria for the study. Placebo controlled.

Group Type PLACEBO_COMPARATOR

Medical treatment

Intervention Type OTHER

Standard medical treatment without physiotherapy.

Physiotherapy program+medical treatment

29 people are recruited in order to the inclusion criteria for the study. Experimental group

Group Type ACTIVE_COMPARATOR

Physiotherapy program+medical treatment

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Medical treatment

Standard medical treatment without physiotherapy.

Intervention Type OTHER

Other Intervention Names

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Physiotherapy Respiratory exercises Strength exercises Drugs

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Marie Carmen Valenza

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Carmen Valenza, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Faculty of Health Sciences. University of Granada.

Granada, Granada, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 27715322 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23882107 (View on PubMed)

Other Identifiers

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DF0039UG

Identifier Type: -

Identifier Source: org_study_id