Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that is characterized by incompletely reversible airflow obstruction. It is projected to be the fifth leading burden of disease worldwide by the year 2020. Pulmonary dysfunction reduces exercise capacity in COPD patients, and it has been previously shown that COPD patients suffer deterioration in their quality of life. The objective of this study is to examine the effects of a physical therapy intervention in stable patients with COPD.

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. Although COPD primarily affects the lungs, it also implies extrapulmonary manifestations, such as nutritional depletion, skeletal muscle dysfunction, and abnormal respiratory muscles. Pulmonary rehabilitation is widely used to treat COPD patients and it has been shown that pulmonary rehabilitation should be implemented at all COPD stages, bringing them benefits in terms of improved exercise capacity, symptoms, and quality of life.

Official Title
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Effects of a Physiotherapy Program in Patients With Stable Chronic Obstructive Pulmonary Disease

Conditions
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COPD

Intervention / Treatment
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* Other: Standard care
* Other: Physiotherapy added to standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD diagnosis No contraindication of physiotherapy. Signed written consent. Medical approval for inclusion. Exclusion Criteria: Acute exacerbation in the previous month Contraindications of physiotherapy. Neurological, orthopedic or heart disease.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care. | Other: Physiotherapy added to standard care<br>* The treatment will be based on domiciliary physiotherapy program during 8 weeks, twice a week added to standard care. The duration of the sessions will be 45-60 minutes. The physiotherapy treatment includes: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband. This will be a home-based program supervised by a physiotherapist.<br>* Other names: Domiciliary physiotherapy;|
| Other: Control group<br>COPD patients with stable disease will be recruited and they will receive standard care. | Other: Standard care<br>* The standard care of stable COPD is based on long-acting bronchodilators (LABD).<br>* Other names: standard treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Muscle strength | Quadriceps strength will be assessed with a portable dynamometer. | Baseline, 8 weeks | 
| Changes in 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. | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Respiratory function | Spirometry is regarded as the gold standard measure of respiratory function. Spirometry will be performed according to the American Thoracic Society (ATS) criteria. | Baseline, 8 weeks | 
| Changes in Dyspnea perception | Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10. | Baseline, 8 weeks | 
| Changes in Quality of life | 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). | Baseline, 8 weeks | 
| Changes in 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. | Baseline, 8 weeks | 
| 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. | Baseline, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, physiotherapy, Stable disease