- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02515318
Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Effects of a Physiotherapy Program in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie Carmen Valenza, PhD
- Phone Number: 958 248035
- Email: cvalenza@ugr.es
Study Locations
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-
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Granada, Spain, 18016
- Recruiting
- University of Granada
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Contact:
- Marie Carmen Valenza, Ph
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Contact:
- Email: cvalenza@ugr.es
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Granada, Spain, 18071
- Recruiting
- Department of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physiotherapy program
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
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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.
Other Names:
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Active Comparator: Control group
Patients with COPD are included in this group.
They will receive the medical standard treatment during the hospitalization due to acute exacerbation of COPD.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Quadriceps strength will be assessed with a portable dynamometer.
The test will be performed as previously reported
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Exercise capacity
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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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.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory function
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Spirometry is regarded as the gold standard measure of respiratory function.
Spirometry will be performed according to the American Thoracic Society criteria.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Dyspnea
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Dyspnea perception will be assessed with Borg modified scale.
Patients will classify their breathlessness between 0 and 10.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Health status
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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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.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Fatigue
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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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.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Impact of COPD
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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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.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dependency levels
Time Frame: Baseline
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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.
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Baseline
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Comorbidities
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0056UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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