Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT ID: NCT02515318

Last Updated: 2018-07-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-07-31

Brief Summary

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Chronic Obstructive Pulmonary Disease (COPD) is projected to be the fifth leading burden of disease worldwide by the year 2020. An acute exacerbation of COPD (AECOPD) is defined as an acute event characterized by a worsening of the patient's respiratory symptoms that requires a modification in the medication. AECOPD are frequent (mean of 1-4 exacerbations each year). It increases in frequency with the severity of the disease. The objective of this study is to examine whether a physical therapy intervention can reduce impairment in patients with COPD during hospitalization due to an acute exacerbation.

Detailed Description

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Chronic obstructive pulmonary disease (COPD) is one of the leading diseases causing mortality and morbidity, despite advanced pharmacotherapy and therapeutic management.

COPD patients suffer frequent exacerbations, defined as 'acute events characterized by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication'. Acute illness and prolonged bed rest are associated with loss of muscle mass and a significant decline in functional ability and mobility. Interventions to counteract these impairments are indicated.

Conditions

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COPD

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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Physiotherapy program

Patients with COPD are included in this group. They will receive a physiotherapy program during the hospitalization due to acute exacerbation of COPD, additionally to the standard medical treatment

Group Type EXPERIMENTAL

Physiotherapy program

Intervention Type OTHER

The physiotherapy treatment will be performed during the hospitalization, every day during 45-60 minutes, and included: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.

Control group

Patients with COPD are included in this group. They will receive the medical standard treatment during the hospitalization due to acute exacerbation of COPD.

Group Type ACTIVE_COMPARATOR

Medical standard treatment

Intervention Type DRUG

The standard medical treatment consists on:

Inhaled bronchodilators: Short acting inhaled β2 agonists ( salbutamol and terbutaline) and anticholinergic agents (ipratropium and oxitropium bromide).

Glucocorticoids:

Inhaled glucocorticoids including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate and triamcinolone acetonide, depending on the expert criteria.

\- Antibiotics: The antibiotics were administered according to the GOLD criteria including the β-lactamase inhibitor and fluoroquinolones.

Interventions

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Physiotherapy program

The physiotherapy treatment will be performed during the hospitalization, every day during 45-60 minutes, and included: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.

Intervention Type OTHER

Medical standard treatment

The standard medical treatment consists on:

Inhaled bronchodilators: Short acting inhaled β2 agonists ( salbutamol and terbutaline) and anticholinergic agents (ipratropium and oxitropium bromide).

Glucocorticoids:

Inhaled glucocorticoids including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate and triamcinolone acetonide, depending on the expert criteria.

\- Antibiotics: The antibiotics were administered according to the GOLD criteria including the β-lactamase inhibitor and fluoroquinolones.

Intervention Type DRUG

Other Intervention Names

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Respiratory exercises Electrostimulation 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

* Neurological, orthopedic or heart diseases.
* Prosthetic devices in the lower limbs.
Minimum Eligible Age

40 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

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Carmen Valenza, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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University of Granada

Granada, , Spain

Site Status RECRUITING

Department of Physical Therapy

Granada, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Marie Carmen Valenza, PhD

Role: CONTACT

958 248035

Facility Contacts

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Marie Carmen Valenza, Ph

Role: primary

Role: backup

Marie Carmen Valenza, PhD

Role: primary

958242360

Other Identifiers

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DF0056UG

Identifier Type: -

Identifier Source: org_study_id

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