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Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Standard care
Physiotherapy added to standard care
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, physiotherapy, Stable disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.

COPD patients with stable disease will be recruited and they will receive standard care.

Outcomes

Primary Outcome Measures

Changes in Muscle strength
Quadriceps strength will be assessed with a portable dynamometer.
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2015
Last Updated
October 30, 2016
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT02517411
Brief Title
Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease
Official Title
Effects of a Physiotherapy Program in Patients With Stable Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, physiotherapy, Stable disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.
Arm Title
Control group
Arm Type
Other
Arm Description
COPD patients with stable disease will be recruited and they will receive standard care.
Intervention Type
Other
Intervention Name(s)
Standard care
Other Intervention Name(s)
standard treatment
Intervention Description
The standard care of stable COPD is based on long-acting bronchodilators (LABD).
Intervention Type
Other
Intervention Name(s)
Physiotherapy added to standard care
Other Intervention Name(s)
Physiotherapy, Home-based program, Domiciliary physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Muscle strength
Description
Quadriceps strength will be assessed with a portable dynamometer.
Time Frame
Baseline, 8 weeks
Title
Changes in Exercise capacity
Description
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
Secondary Outcome Measure Information:
Title
Changes in Respiratory function
Description
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
Title
Changes in Dyspnea perception
Description
Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.
Time Frame
Baseline, 8 weeks
Title
Changes in Quality of life
Description
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
Title
Changes in Fatigue
Description
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
Title
Impact of COPD
Description
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
Other Pre-specified Outcome Measures:
Title
Quality of life related to respiratory symptoms
Description
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
Title
Peripheral vascular status
Description
Ankle-brachial index will be used to predict the presence or absence of peripheral arterial disease.
Time Frame
Baseline
Title
Physical activity
Description
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
Title
Cognitive status
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease

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