Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy program
Medical standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, Exacerbation, Hospitalisation, Physiotherapy
Eligibility Criteria
Inclusion Criteria:
- COPD diagnosis with exacerbation.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion
Exclusion Criteria:
- Neurological, orthopedic or heart diseases.
- Prosthetic devices in the lower limbs.
Sites / Locations
- University of GranadaRecruiting
- Department of Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physiotherapy program
Control group
Arm Description
Patients with COPD are included in this group. They will receive a physiotherapy program during the hospitalization due to acute exacerbation of COPD, additionally to the standard medical treatment
Patients with COPD are included in this group. They will receive the medical standard treatment during the hospitalization due to acute exacerbation of COPD.
Outcomes
Primary Outcome Measures
Muscle strength
Quadriceps strength will be assessed with a portable dynamometer. The test will be performed as previously reported
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
Respiratory function
Spirometry is regarded as the gold standard measure of respiratory function. Spirometry will be performed according to the American Thoracic Society criteria.
Dyspnea
Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.
Health status
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). Each item has three levels: no problem, some problem and severe problem.
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
1. Study Identification
Unique Protocol Identification Number
NCT02515318
Brief Title
Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official Title
Effects of a Physiotherapy Program in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 2018 (Anticipated)
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 projected to be the fifth leading burden of disease worldwide by the year 2020. An acute exacerbation of COPD (AECOPD) is defined as an acute event characterized by a worsening of the patient's respiratory symptoms that requires a modification in the medication. AECOPD are frequent (mean of 1-4 exacerbations each year). It increases in frequency with the severity of the disease. The objective of this study is to examine whether a physical therapy intervention can reduce impairment in patients with COPD during hospitalization due to an acute exacerbation.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is one of the leading diseases causing mortality and morbidity, despite advanced pharmacotherapy and therapeutic management.
COPD patients suffer frequent exacerbations, defined as 'acute events characterized by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication'. Acute illness and prolonged bed rest are associated with loss of muscle mass and a significant decline in functional ability and mobility. Interventions to counteract these impairments are indicated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, Exacerbation, Hospitalisation, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy program
Arm Type
Experimental
Arm Description
Patients with COPD are included in this group. They will receive a physiotherapy program during the hospitalization due to acute exacerbation of COPD, additionally to the standard medical treatment
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients with COPD are included in this group. They will receive the medical standard treatment during the hospitalization due to acute exacerbation of COPD.
Intervention Type
Other
Intervention Name(s)
Physiotherapy program
Other Intervention Name(s)
Respiratory exercises, Electrostimulation
Intervention Description
The physiotherapy treatment will be performed during the hospitalization, every day during 45-60 minutes, and included: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.
Intervention Type
Drug
Intervention Name(s)
Medical standard treatment
Other Intervention Name(s)
Drugs
Intervention Description
The standard medical treatment consists on:
Inhaled bronchodilators: Short acting inhaled β2 agonists ( salbutamol and terbutaline) and anticholinergic agents (ipratropium and oxitropium bromide).
Glucocorticoids:
Inhaled glucocorticoids including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate and triamcinolone acetonide, depending on the expert criteria.
- Antibiotics: The antibiotics were administered according to the GOLD criteria including the β-lactamase inhibitor and fluoroquinolones.
Primary Outcome Measure Information:
Title
Muscle strength
Description
Quadriceps strength will be assessed with a portable dynamometer. The test will be performed as previously reported
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Title
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
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Secondary Outcome Measure Information:
Title
Respiratory function
Description
Spirometry is regarded as the gold standard measure of respiratory function. Spirometry will be performed according to the American Thoracic Society criteria.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Title
Dyspnea
Description
Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Title
Health status
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). Each item has three levels: no problem, some problem and severe problem.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Title
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
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Other Pre-specified Outcome Measures:
Title
Dependency levels
Description
Dependency levels will be evaluated with the Functional Independence Measure (FIM). It is an 18-item, 7-level scale developed to uniformly assess severity of patient disability and medical rehabilitation functional outcome.
Time Frame
Baseline
Title
Comorbidities
Description
Charlson Comorbidity Index will be used to assess the comorbidities of the patients, it is a simple and valid method of estimating risk of death from comorbid disease. It contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned with a score of 1, 2, 3 or 6 depending on the risk of dying associated with this condition.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD diagnosis with exacerbation.
No contraindication of physiotherapy.
Signed written consent.
Medical approval for inclusion
Exclusion Criteria:
Neurological, orthopedic or heart diseases.
Prosthetic devices in the lower limbs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carmen Valenza, PhD
Phone
958 248035
Email
cvalenza@ugr.es
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
University of Granada
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, Ph
Email
cvalenza@ugr.es
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Phone
958242360
Email
cvalenza@ugr.es
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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