Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Physiotherapy added to standard care; Other: Standard care

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18071
    • Department of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.	Other: Physiotherapy added to standard care; 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.; Other Names: Physiotherapy; Home-based program; Domiciliary physiotherapy
Other: Control group; 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).; Other Names: standard treatment

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
Peripheral vascular status	Ankle-brachial index will be used to predict the presence or absence of peripheral arterial disease.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 2, 2015
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 30, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: COPD; physiotherapy; Stable disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: DF0058UG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED