Chronic Obstructive Pulmonary DiseaseNCT01295359
Impact of a Hospital Physical Therapy Program on Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Ground Walking Program in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and mortality, so it's important to find actions that could improve quality of life and decrease the mortality. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Ground Walking Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Aug 2012
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD Patients (FEV1/FVC < 0,70; FEV1 > 30% and < 80%)
- Hospitalized for exacerbation of COPD
Who cannot join
- Conditions that could restrict walking
- Skeletal-muscle and joint disturbs
- Extreme Obesity (BMI > 35kg/m²)
- Heart Failure (New York Heart Association class III and IV)
- Uncontrolled infection (fever > 38ºC and leukocytosis > 10000 cels/dl)
- Need of Invasive Mechanical Ventilation after the beginning of the program
Show all 16Show fewer
- Previous Diagnosis of:
- Stroke
- Epilepsy
- Coagulation disorders (INR > 1,5 or platelets < 50.000/m³)
- Psychiatric Disorders or severe agitation
- Cardiac or respiratory instability
- Oxygen therapy > 3L/min at rest
- Respiratory Rate > 30 breaths/min at rest
- Tachycardia and Bradycardia
- Vasoactive Drugs need
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Escola Municipal "Dr Horácio Carlos Panepucci
São Carlos, São Paulo, 13566-488
Mariza Borges Brito de Souza, PhD, 33625555, souzamar@ufscar.br
Juliano Ferreira Arcuri, Especialist
About this study
Official title: Impact of a Hospital Physical Therapy Program on Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial
The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and mortality, so it's important to find actions that could improve quality of life and decrease the mortality. The objective of this study is to verify if a ground walking program applied to hospitalized exacerbated COPD patients has effects in quality of life, exercise capacity, airways obstruction, body composition, heart rate variability, quadriceps isometric force and in the "Body-mass index, Airway Obstruction, Dyspnea, Exercise Capacity index" (BODE index). An evaluators-blinded randomized controlled study will be conducted in "Hospital Escola Municipal de São Carlos" where forty patients will be recruited to participate. The volunteers will be randomized in two groups with twenty patients, the usual care group, that will receive only the usual care of the hospital; and the trained group that will receive the same care, but will also participate in a ground walking program associated with respiratory exercises. It will be evaluated, in the start and at the end of the program, the health related and general quality of life and the Barthel index. Daily, the patient will be submitted to the Six Minute Walk Test, to a body composition analysis, to a hand grip test and to a dyspnea assessment, and will be calculated its BODE index. All patients will be invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would receive the same evaluation of the last day in the hospital. All the collected data will be expressed in means and standard deviations or medians and range when appropriated. It will be chosen appropriated tests to compare and correlate them.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Ground Walking Program
- Keywords
- Chronic Obstructive Pulmonary Disease, Walking, Hospital, Exercise Tolerance, Physical Therapy
- 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.
Ground Walking ProgramOther
Also called Physical Therapy, Respiratory Rehabilitation
The patients will walk on a corridor, for 40min, once a day. The speed will be controlled through a metronome, that will be programed to a frequency of steps/min determinated as 80% of the mean frequency of steps performed in six minutes walk test of that day. The 40min will be divided in 3min of walk and 2min of rest, totalizing 24min of exercise and 16min of rest. Furthermore, these patients, in sitting position, will receive orientation to do calm and slow inspirations and expirations, associated with pursed lips expiration. They will try to maintain its Respiratory Rate in 6bpm, during four minutes.
| Study group | Role | What they receive |
|---|---|---|
| Trained Group | Experimental | This group will receive the usual care of the hospital and a ground walking training program associated with respiratory exercises. Receives: Other: Ground Walking Program |
| Usual Care Group | No intervention | This group will only receive the usual care of the hospital, including physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Capacity
It will be evaluated through the six minutes walking distance, performed according to ATS rules.
Measured: Daily, as soon as medically appropriated, during the hospitalization
Change in BODE index
The Body-Mass Index, Airways Obstruction, Dyspnea, Exercise Capacity (BODE) index. This is a multidimensional evaluation that includes Forced Expiratory Volume in the first second, Body-Mass Index, 6 Minutes Walking Distance and mMRC score. It is an index to predict mortality.
Measured: Daily, as soon as medically appropriated, during the hospitalization
Secondary outcomes (12)
Change in Perceived Dyspnea
Dyspnea during the six minutes walk test through the BORG CR10 scale
Measured: Daily, as soon as medically appropriated, during the hospitalization
Change in Perceived discomfort in lower limbs
Evaluated during the six minutes walk test through the BORG CR10 scale
Measured: Daily, as soon as medically appropriated, during the hospitalization
Change in Variation in Heart Rate
It will be evaluated the variation in the Heart Rate during the six minutes walk test (Exercise Peak - rest)
Measured: Daily, as soon as medically appropriated, during the hospitalization
Change in the need of oxygen therapy
Will be evaluated the need of oxygen therapy during the six minutes walk test
Measured: Daily, as soon as medically appropriated, during the hospitalization
Change in Handgrip Isometric Force
It will be evaluated through a hand grip dynamometer.
Measured: Daily, as soon as medically appropriated, during the hospitalization
Change in General Quality of Life
It will be evaluated through the SF-36 questionnaire
Measured: first day of the protocol and at the day of discharge
Change in Body Composition
It will be performed through a body composition monitor, evaluating weight, body Fat percentage, Muscle Mass, Basal Metabolic Rate, Bone Mass and Total Body Water Percentage.
Measured: Daily, as soon as medically appropriated, during the hospitalization
Change in Forced Expiratory Volume in the First Second
It will be evaluated through espirometry
Measured: Daily, as soon as medically appropriated, during the hospitalization
Days in hospital
Measured: At the discharge
Change in Reported Dyspnea
It will be evaluated through the Modified Medical Research Concil Questionnaire
Measured: Daily, as soon as medically appropriated, during the hospitalization
Change in Heart Rate Variability
It will be recorded through a cardiac monitor, and analized in the time and frequency domain, and non-linear analysis.
Measured: first day of the protocol and at the day of discharge
Quadriceps Isometric Force
It will be evaluated through a hand held dynamometer.
Measured: first day of the protocol and at the day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Valéria Amorim Pires Di Lorenzo, PhD, Study director, Universidade Federal de Sao CarlosAdriana Sanches Garcia de Araujo, Masters, Principal investigator, Universidade Federal de Sao CarlosJuliano Ferreira Arcuri, Especialist, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295359
- Sponsor's protocol ID
- DPOCexacaminhada
- Status last verified
- Feb 2011
- First submitted
- 11 Feb 2011
- Last updated
- 21 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson D, Macnee W. Targeted treatment in COPD: a multi-system approach for a multi-system disease. Int J Chron Obstruct Pulmon Dis. 2009;4:321-35. doi: 10.2147/copd.s2999. Epub 2009 Sep 1.
PubMed 19750192ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Behnke M, Taube C, Kirsten D, Lehnigk B, Jorres RA, Magnussen H. Home-based exercise is capable of preserving hospital-based improvements in severe chronic obstructive pulmonary disease. Respir Med. 2000 Dec;94(12):1184-91. doi: 10.1053/rmed.2000.0949.
PubMed 11192954Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
PubMed 19623052Burge S, Wedzicha JA. COPD exacerbations: definitions and classifications. Eur Respir J Suppl. 2003 Jun;41:46s-53s. doi: 10.1183/09031936.03.00078002.
PubMed 12795331Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
PubMed 14999112Eaton T, Young P, Fergusson W, Moodie L, Zeng I, O'Kane F, Good N, Rhodes L, Poole P, Kolbe J. Does early pulmonary rehabilitation reduce acute health-care utilization in COPD patients admitted with an exacerbation? A randomized controlled study. Respirology. 2009 Mar;14(2):230-8. doi: 10.1111/j.1440-1843.2008.01418.x.
PubMed 19272084Faganello MM, Tanni SE, Sanchez FF, Pelegrino NR, Lucheta PA, Godoy I. BODE index and GOLD staging as predictors of 1-year exacerbation risk in chronic obstructive pulmonary disease. Am J Med Sci. 2010 Jan;339(1):10-4. doi: 10.1097/MAJ.0b013e3181bb8111.
PubMed 19926966Gerardi DA, Lovett L, Benoit-Connors ML, Reardon JZ, ZuWallack RL. Variables related to increased mortality following out-patient pulmonary rehabilitation. Eur Respir J. 1996 Mar;9(3):431-5. doi: 10.1183/09031936.96.09030431.
PubMed 8730000Kovelis D, Segretti NO, Probst VS, Lareau SC, Brunetto AF, Pitta F. Validation of the Modified Pulmonary Functional Status and Dyspnea Questionnaire and the Medical Research Council scale for use in Brazilian patients with chronic obstructive pulmonary disease. J Bras Pneumol. 2008 Dec;34(12):1008-18. doi: 10.1590/s1806-37132008001200005. English, Portuguese.
PubMed 19180335Iucif N Jr, Rocha JS. [Study of inequalities in hospital mortality using the Charlson comorbidity index]. Rev Saude Publica. 2004 Dec;38(6):780-6. doi: 10.1590/s0034-89102004000600005. Epub 2004 Dec 10. Portuguese.
PubMed 15608895MacNee W, Tuder RM. New paradigms in the pathogenesis of chronic obstructive pulmonary disease I. Proc Am Thorac Soc. 2009 Sep 15;6(6):527-31. doi: 10.1513/pats.200905-027DS.
PubMed 19741262Mathers CD, Boerma T, Ma Fat D. Global and regional causes of death. Br Med Bull. 2009;92:7-32. doi: 10.1093/bmb/ldp028.
PubMed 19776034Nasis IG, Vogiatzis I, Stratakos G, Athanasopoulos D, Koutsoukou A, Daskalakis A, Spetsioti S, Evangelodimou A, Roussos C, Zakynthinos S. Effects of interval-load versus constant-load training on the BODE index in COPD patients. Respir Med. 2009 Sep;103(9):1392-8. doi: 10.1016/j.rmed.2009.03.003. Epub 2009 Apr 5.
PubMed 19349153Murphy N, Bell C, Costello RW. Extending a home from hospital care programme for COPD exacerbations to include pulmonary rehabilitation. Respir Med. 2005 Oct;99(10):1297-302. doi: 10.1016/j.rmed.2005.02.033. Epub 2005 Mar 31.
PubMed 16140230
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Hospital Physical Therapy Program on Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01295359
- Acronym / sponsor ID
- DPOCexacaminhada
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Walking, Hospital, Exercise Tolerance, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 14 Feb 2011 (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.
The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and mortality, so it's important to find actions that could improve quality of life and decrease the mortality. The objective of this study is to verify if a ground walking program applied to hospitalized exacerbated COPD patients has effects in quality of life, exercise capacity, airways obstruction, body composition, heart rate variability, quadriceps isometric force and in the "Body-mass index, Airway Obstruction, Dyspnea, Exercise Capacity index" (BODE index). An evaluators-blinded randomized controlled study will be conducted in "Hospital Escola Municipal de São Carlos" where forty patients will be recruited to participate. The volunteers will be randomized in two groups with twenty patients, the usual care group, that will receive only the usual care of the hospital; and the trained group that will receive the same care, but will also participate in a ground walking program associated with respiratory exercises. It will be evaluated, in the start and at the end of the program, the health related and general quality of life and the Barthel index. Daily, the patient will be submitted to the Six Minute Walk Test, to a body composition analysis, to a hand grip test and to a dyspnea assessment, and will be calculated its BODE index. All patients will be invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would receive the same evaluation of the last day in the hospital. All the collected data will be expressed in means and standard deviations or medians and range when appropriated. It will be chosen appropriated tests to compare and correlate them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trained Group | Experimental | Other: Ground Walking ProgramThis group will receive the usual care of the hospital and a ground walking training program associated with respiratory exercises. |
| Usual Care Group | No intervention | –This group will only receive the usual care of the hospital, including physical therapy |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD Patients (FEV1/FVC < 0,70; FEV1 > 30% and < 80%)
- Hospitalized for exacerbation of COPD
Key exclusion criteria (16 listed)
- Conditions that could restrict walking
- Heart Failure (New York Heart Association class III and IV)
- Uncontrolled infection (fever > 38ºC and leukocytosis > 10000 cels/dl)
- Need of Invasive Mechanical Ventilation after the beginning of the program
- Previous Diagnosis of:
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 |
|---|---|---|
| Ground Walking ProgramAlso: Physical Therapy, Respiratory RehabilitationThe patients will walk on a corridor, for 40min, once a day. The speed will be controlled through a metronome, that will be programed to a frequency of steps/min determinated as 80% of the mean frequency of steps performed in six minutes walk test of that day. The 40min will be divided in 3min of walk and 2min of rest, totalizing 24min of exercise and 16min of rest. Furthermore, these patients, in sitting position, will receive orientation to do calm and slow inspirations and expirations, associated with pursed lips expiration. They will try to maintain its Respiratory Rate in 6bpm, during four minutes. | Other | Trained Group |
Primary outcome
Change in Exercise Capacity
Time frame: Daily, as soon as medically appropriated, during the hospitalization
It will be evaluated through the six minutes walking distance, performed according to ATS rules.
Change in BODE index
Time frame: Daily, as soon as medically appropriated, during the hospitalization
The Body-Mass Index, Airways Obstruction, Dyspnea, Exercise Capacity (BODE) index. This is a multidimensional evaluation that includes Forced Expiratory Volume in the first second, Body-Mass Index, 6 Minutes Walking Distance and mMRC score. It is an index to predict mortality.
12 secondary outcomes
Change in Perceived Dyspnea
Time frame: Daily, as soon as medically appropriated, during the hospitalization
Change in Perceived discomfort in lower limbs
Time frame: Daily, as soon as medically appropriated, during the hospitalization
Change in Variation in Heart Rate
Time frame: Daily, as soon as medically appropriated, during the hospitalization
Change in the need of oxygen therapy
Time frame: Daily, as soon as medically appropriated, during the hospitalization
Change in Handgrip Isometric Force
Time frame: Daily, as soon as medically appropriated, during the hospitalization
Change in General Quality of Life
Time frame: first day of the protocol and at the day of discharge
Change in Body Composition
Time frame: Daily, as soon as medically appropriated, during the hospitalization
Change in Forced Expiratory Volume in the First Second
Time frame: Daily, as soon as medically appropriated, during the hospitalization
Days in hospital
Time frame: At the discharge
Change in Reported Dyspnea
Time frame: Daily, as soon as medically appropriated, during the hospitalization
Change in Heart Rate Variability
Time frame: first day of the protocol and at the day of discharge
Quadriceps Isometric Force
Time frame: first day of the protocol and at the day of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2011.
- Background: PubMed 19750192Anderson D, Macnee W. Targeted treatment in COPD: a multi-system approach for a multi-system disease. Int J Chron Obstruct Pulmon Dis. 2009;4:321-35. doi: 10.2147/copd.s2999. Epub 2009 Sep 1.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 11192954Behnke M, Taube C, Kirsten D, Lehnigk B, Jorres RA, Magnussen H. Home-based exercise is capable of preserving hospital-based improvements in severe chronic obstructive pulmonary disease. Respir Med. 2000 Dec;94(12):1184-91. doi: 10.1053/rmed.2000.0949.
- Background: PubMed 19623052Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
- Background: PubMed 12795331Burge S, Wedzicha JA. COPD exacerbations: definitions and classifications. Eur Respir J Suppl. 2003 Jun;41:46s-53s. doi: 10.1183/09031936.03.00078002.
- Background: PubMed 14999112Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
- Background: PubMed 19272084Eaton T, Young P, Fergusson W, Moodie L, Zeng I, O'Kane F, Good N, Rhodes L, Poole P, Kolbe J. Does early pulmonary rehabilitation reduce acute health-care utilization in COPD patients admitted with an exacerbation? A randomized controlled study. Respirology. 2009 Mar;14(2):230-8. doi: 10.1111/j.1440-1843.2008.01418.x.
- Background: PubMed 19926966Faganello MM, Tanni SE, Sanchez FF, Pelegrino NR, Lucheta PA, Godoy I. BODE index and GOLD staging as predictors of 1-year exacerbation risk in chronic obstructive pulmonary disease. Am J Med Sci. 2010 Jan;339(1):10-4. doi: 10.1097/MAJ.0b013e3181bb8111.
- Background: PubMed 8730000Gerardi DA, Lovett L, Benoit-Connors ML, Reardon JZ, ZuWallack RL. Variables related to increased mortality following out-patient pulmonary rehabilitation. Eur Respir J. 1996 Mar;9(3):431-5. doi: 10.1183/09031936.96.09030431.
- Background: PubMed 19180335Kovelis D, Segretti NO, Probst VS, Lareau SC, Brunetto AF, Pitta F. Validation of the Modified Pulmonary Functional Status and Dyspnea Questionnaire and the Medical Research Council scale for use in Brazilian patients with chronic obstructive pulmonary disease. J Bras Pneumol. 2008 Dec;34(12):1008-18. doi: 10.1590/s1806-37132008001200005. English, Portuguese.
- Background: PubMed 15608895Iucif N Jr, Rocha JS. [Study of inequalities in hospital mortality using the Charlson comorbidity index]. Rev Saude Publica. 2004 Dec;38(6):780-6. doi: 10.1590/s0034-89102004000600005. Epub 2004 Dec 10. Portuguese.
- Background: PubMed 19741262MacNee W, Tuder RM. New paradigms in the pathogenesis of chronic obstructive pulmonary disease I. Proc Am Thorac Soc. 2009 Sep 15;6(6):527-31. doi: 10.1513/pats.200905-027DS.
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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.
Valéria Amorim Pires Di Lorenzo, PhD study director
Universidade Federal de Sao Carlos
Adriana Sanches Garcia de Araujo, Masters principal investigator
Universidade Federal de Sao Carlos
Juliano Ferreira Arcuri, Especialist principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ground Walking Program in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 2 inclusion and 16 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 21 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 Juliano Ferreira Arcuri, Especialist (+55 (16) 97838283, julianoarcuri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Capacity (time frame: Daily, as soon as medically appropriated, during the hospitalization). 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?
On the ClinicalTrials.gov record for NCT01295359, which also lists 23 linked publications.
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 21 Mar 2011.