Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02515318
• Other study ID #: DF0056UG
• Status: Recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Universidad de Granada
• Contact: Marie Carmen Valenza, PhD
• Phone: 958 248035
• Email: cvalenza[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.

Drug:
• Medical standard treatment
The standard medical treatment consists on: Inhaled bronchodilators: Short acting inhaled ß2 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 ß-lactamase inhibitor and fluoroquinolones.

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dependency levels	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
Other	Comorbidities	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
Primary	Muscle strength	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.
Primary	Exercise capacity	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	Respiratory function	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.
Secondary	Dyspnea	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.
Secondary	Health status	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.
Secondary	Fatigue	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.
Secondary	Impact of COPD	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.