COPDNCT02515318
Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing Physiotherapy program and Medical standard treatment in people with COPD, run by Universidad de Granada at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Physiotherapy program and Medical standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis with exacerbation.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion
Who cannot join
- Neurological, orthopedic or heart diseases.
- Prosthetic devices in the lower limbs.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
University of Granada
Granada, 18016
Marie Carmen Valenza, Ph
cvalenza@ugr.es
- Recruiting
Department of Physical Therapy
Granada, 18071
Marie Carmen Valenza, PhD, 958242360, cvalenza@ugr.es
Marie Carmen Valenza, PhD
About this study
Official title: Effects of a Physiotherapy Program in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Physiotherapy program, Medical standard treatment
- Keywords
- COPD, Exacerbation, Hospitalisation, Physiotherapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy programOther
Also called Respiratory exercises, Electrostimulation
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.
Medical standard treatmentDrug
Also called Drugs
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy program | Experimental | 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 Receives: Other: Physiotherapy program |
| Control group | Active comparator | Patients with COPD are included in this group. They will receive the medical standard treatment during the hospitalization due to acute exacerbation of COPD. Receives: Drug: Medical standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Quadriceps strength will be assessed with a portable dynamometer. The test will be performed as previously reported
Measured: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Secondary outcomes (5)
Respiratory function
Spirometry is regarded as the gold standard measure of respiratory function. Spirometry will be performed according to the American Thoracic Society criteria.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Dyspnea
Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515318
- Sponsor's protocol ID
- DF0056UG
- Status last verified
- Jul 2018
- First submitted
- 1 Aug 2015
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physiotherapy Program in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02515318
- Acronym / sponsor ID
- DF0056UG
- Conditions
- COPD
- Keywords
- COPD, Exacerbation, Hospitalisation, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2018 (estimated)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy program | Experimental | Other: Physiotherapy programPatients 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 |
| Control group | Active comparator | Drug: Medical standard treatmentPatients with COPD are included in this group. They will receive the medical standard treatment during the hospitalization due to acute exacerbation of COPD. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD diagnosis with exacerbation.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion
Key exclusion criteria (2 listed)
- Neurological, orthopedic or heart diseases.
- Prosthetic devices in the lower limbs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy programAlso: Respiratory exercises, ElectrostimulationThe 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 | Physiotherapy program |
| Medical standard treatmentAlso: DrugsThe 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. | Drug | Control group |
Primary outcome
Muscle strength
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Quadriceps strength will be assessed with a portable dynamometer. The test will be performed as previously reported
Exercise capacity
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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.
5 secondary outcomes
Respiratory function
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Dyspnea
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Health status
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Fatigue
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Impact of COPD
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy program and Medical standard treatment in people with COPD, run by Universidad de Granada at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza, PhD (958 248035, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.