Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Physiotherapy added to standard care; Other: Standard care

• Registration Number: NCT02517411
• Lead Sponsor: Universidad de Granada

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-08-02
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-07
• Study Start: 2015-09
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-30
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Physiotherapy added to standard care	COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.
Control group	Standard care	COPD patients with stable disease will be recruited and they will receive standard care.

Primary Outcome Measures

Name	Time	Method
Changes in Muscle strength	Baseline, 8 weeks	Quadriceps strength will be assessed with a portable dynamometer.
Changes in Exercise capacity	Baseline, 8 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Physical Therapy; 🇪🇸 Granada, Spain