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Completed

NCT Number: NCT02517411

Physiotherapy 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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy

Granada, 18071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard care

Other

The standard care of stable COPD is based on long-acting bronchodilators (LABD).

Other names: standard treatment

Physiotherapy added to standard care

Other

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

Primary outcomes

  1. Changes in Muscle strength

    Time frame: Baseline, 8 weeks

    Quadriceps strength will be assessed with a portable dynamometer.

  2. Changes in Exercise capacity

    Time frame: 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 outcomes

  1. Changes in Respiratory function

    Time frame: 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.

  2. Changes in Dyspnea perception

    Time frame: Baseline, 8 weeks

    Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.

  3. Changes in Quality of life

    Time frame: 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).

  4. Changes in Fatigue

    Time frame: 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.

  5. Impact of COPD

    Time frame: 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.

Other outcomes

  1. Quality of life related to respiratory symptoms

    Time frame: Baseline

    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.

  2. Peripheral vascular status

    Time frame: Baseline

    Ankle-brachial index will be used to predict the presence or absence of peripheral arterial disease.

  3. Physical activity

    Time frame: Baseline

    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.

  4. Cognitive status

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2015
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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