An interventional study of Standard care and Physiotherapy added to standard care in COPD, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-11-01.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment
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.
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.
2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 40 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.
Other: Physiotherapy added to standard care
COPD patients with stable disease will be recruited and they will receive standard care.
Other: Standard care
The standard care of stable COPD is based on long-acting bronchodilators (LABD).
Also known as: standard treatment
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.
Also known as: Physiotherapy, Home-based program, Domiciliary physiotherapy
Changes in Muscle strength
Quadriceps strength will be assessed with a portable dynamometer.
Time frame: 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.
Time frame: Baseline, 8 weeks
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 8 weeks
Quality of life related to respiratory symptoms
Saint George Respiratory Questionnaire (SGRQ) will be also used to evaluate the quality of life of patients in the previous year. It includes 50 items, divided into three domains: Symptoms, Activity and Impacts. A score is calculated for each domain and a total score including all items is also obtained. Low scores indicate better health related quality of life.
Time frame: Baseline
Peripheral vascular status
Ankle-brachial index will be used to predict the presence or absence of peripheral arterial disease.
Time frame: Baseline
Physical activity
Modified Baecke Questionnaire will be used to assess the physical activity levels. It is a frequently used questionnaire to measure habitual physical activity in the elderly.
Time frame: Baseline
Cognitive status
Cognitive status will be assessed with Montreal Cognitive Assessment test (MoCA) which is a cognitive screening test designed to assist Health Professionals for detection of mild cognitive impairment.
Time frame: Baseline
Plan to share: Undecided
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Universidad de Granada