Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

July 11, 2018 updated by: Marie Carmen Valenza, Universidad de Granada

Effects of a Physiotherapy Program in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

  • Name: Marie Carmen Valenza, PhD
  • Phone Number: 958 248035
  • Email: cvalenza@ugr.es

Study Locations

      • Granada, Spain, 18016
        • Recruiting
        • University of Granada
        • Contact:
          • Marie Carmen Valenza, Ph
        • Contact:
      • Granada, Spain, 18071
        • Recruiting
        • Department of Physical Therapy

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

38 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:

  • Neurological, orthopedic or heart diseases.
  • Prosthetic devices in the lower limbs.

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
Experimental: 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
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.
Other Names:
  • Respiratory exercises
  • Electrostimulation
Active Comparator: 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.

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.

Other Names:
  • Drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Quadriceps strength will be assessed with a portable dynamometer. The test will be performed as previously reported
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Exercise capacity
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Five times sit to stand test (5STS) will be used to assess exercise capacity, 5STS is a simple assessment tool that is feasible in all healthcare settings, and may be a rapid method of assessing changes in exercise capacity in COPD and screening for poor physical functioning individuals.
Participants will be followed for the duration of hospital stay, an expected average of 9 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory function
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Spirometry is regarded as the gold standard measure of respiratory function. Spirometry will be performed according to the American Thoracic Society criteria.
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Dyspnea
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Health status
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
EuroQol-5D (EQ-5D) will be used to assess quality of life. EQ-5D is a generic questionnaire and consists of two parts, the EQ-5D Visual analogue scale (VAS) and the EQ-5D index. The EQ-5D VAS consists on a vertical rating scale from 0 to 100 (0 = death/worst possible health state and 100 = best possible health state). The EQ-5D index is a five-item questionnaire (mobility, self-care, usual activity, pain/discomfort and anxiety/depression). Each item has three levels: no problem, some problem and severe problem.
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Fatigue
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Fatigue will be assessed with the Fatigue Severity Scale (FSS). The FSS is a nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them.
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Impact of COPD
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
The impact of COPD in patient's life will be evaluated with COPD Assessment Test (CAT) that is a simple instrument to quantify chronic obstructive pulmonary disease (COPD) impact in routine practice.
Participants will be followed for the duration of hospital stay, an expected average of 9 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dependency levels
Time Frame: Baseline
Dependency levels will be evaluated with the Functional Independence Measure (FIM). It is an 18-item, 7-level scale developed to uniformly assess severity of patient disability and medical rehabilitation functional outcome.
Baseline
Comorbidities
Time Frame: Baseline
Charlson Comorbidity Index will be used to assess the comorbidities of the patients, it is a simple and valid method of estimating risk of death from comorbid disease. It contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned with a score of 1, 2, 3 or 6 depending on the risk of dying associated with this condition.
Baseline

Collaborators and Investigators

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

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 (Actual)

September 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

August 1, 2015

First Submitted That Met QC Criteria

August 3, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Actual)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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