COPD
Conditions
Keywords
COPD, Exacerbation, Hospitalisation, Physiotherapy
Brief 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.
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.
Interventions
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.
DRUGMedical 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.
Sponsors
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | 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. |
| Muscle strength | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | 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. |
| Fatigue | 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. |
| Impact of COPD | 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. |
| Health status | 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. |
| Respiratory function | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dependency levels | 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. |
| Comorbidities | 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. |
Countries
Spain
Contacts
Primary ContactMarie Carmen Valenza, PhD
Outcome results
None listed