Chronic Obstructive Pulmonary DiseaseNCT03131752
Early Pulmonary Rehabilitation in Exacerbated COPD Patients
A study testing Elastic Resistance Intervention in Exacerbated Patients in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic and progressive airflow limitations and subjects with COPD also experience exacerbations characterized by the worsening of respiratory symptoms. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Elastic Resistance Intervention in Exacerbated Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jun 2017to 7 Mar 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40 years or more, of both genders, who are in a an exacerbation of the disease according to Global Initiative for Chronic Obstructive Lung Disease (GOLD,2015) refered by the doctors, hospitalized or not in exacerbation treatment .All patients should be in spontaneous breathing at the time of assessment, in oxygen use or not and in conditions to understand the proposed evaluations; Patients who use non-invasive ventilation will also be included as long as it does not interfere with the protocols; All should agree to participate in the research in a free and informed manner. Patients who are referred to the Intensive Care Unit (ICU) may be included 24 hours after discharge from the ICU.
Who cannot join
- Patients who present with orthopedic limitations, other pulmonary diseases, rheumatological, cardiovascular or neurological disorders that not allow the assessment. Patients whit drug os alcohol dependence, patients undergoing invasive mechanical ventilation, hemodynamic instability, the presence of unstable angina, will be excluded. In addition, patients with cognitive deficits that impair comprehension of the assessments will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Special Respiratory Physiotherapy Unit of the Federal University of São Carlos
São Carlos, São Paulo, 13561-206
Valeria Di Lorenzo, PhD, +55 (16) 33518343, vallorenzo@ufscar.br
Anna Claudia Sentanin, Ms
About this study
Official title: Early Pulmonary Rehabilitation With Elastic Resistance in Exacerbated COPD Patients
Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic and progressive airflow limitations and subjects with COPD also experience exacerbations characterized by the worsening of respiratory symptoms. It's necessary medical intervention, changes in regular medication, and the use of antibiotics and/or corticosteroids followed or not by hospitalization. The exacerbations contribute to worsening of the disease with systemic impairment and muscle weakness is a very relevant event. The physical inactivity, especially related to bed rest, comprises one of the factors contributing to muscle atrophy and loss of muscle strength. Thus, the intervention performed during hospitalization is necessary to minimize the consequences which causes impairment in health status subjects. The aim of the study is assess the effect of the intervention with elastic bands, in muscle strength,level of the physical activity, functional capacity, dyspnea on activities of daily living (ADL) and quality of life in COPD exacerbation subjects. Moreover,verify the intervention benefits over 01 and 03 months post exacerbation episode. It will be a prospective, randomized, longitudinal and interventional study. The investigators will be asses both gender patients with exacerbation of COPD in 4 situations: First time (at least 24 and at most 48 hours after the beginning of medical therapy); seven days post the first assessment; one and three months post exacerbation episode. It will be assess the muscle strength, physical activity level, functional capacity, dyspnea on ADL and quality of life. The patients will be randomized in 2 groups: intervention and control group. The intervention will be performed with elastic bands once a day during seven days. The investigators expected that patients of the intervention group will present better muscle strength, physical activity level and functional capacity than the control group. Furthermore, an improvement in dyspnea and quality of life is expected in intervention group when compared as with control group patients. It is hypothesized that the benefits of intervention will be maintained over one month.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Elastic Resistance Intervention in Exacerbated Patients
- Keywords
- chronic obstructive pulmonary disease, muscle strength, physical activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Resistance Intervention in Exacerbated PatientsBehavioural
Also called GI
The intervention protocol will performed during 7 days for all patients and this will begin 24 -48 hours after the start of medication for exacerbation. Those who are hospitalized and discharged before this period will continue their treatment at the Laboratory of Spirometry and Respiratory Physiotherapy (LEFIR) of the Federal University of São Carlos. The intervention will also perform for at least 5 continuous days. The ideal elastic band for the training will be chosen through the test of 10 maximum repetitions. The test and the training will be performed in an ergonomic chair allowing the lower limbs to remain pending. After 24 hours of the test, patients will perform knee extension exercise with the appropriate elastic band. Three sets of 10 repetitions will be done in each exercise, with a minimum rest interval of 1 minute between sets or until heart rate values return to baseline. Patients will be re-evaluated 1 and 3 months after the first contact.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The patients will be evaluated on 4 phases: at the first contact (at least 24 hours after drug therapy and at most 48 hours), 7 days, 30 days and 3 months after the first contact. They will be submitted to an anamnesis, assessment of muscular strength, physical activity level, functional capacity, dyspnea on activity daily living and quality of life.
The intervention will last 7 days for all the patients. Three phases will be performed: warm up, knee muscle strengthening with elastic bands and stretch/relax. Receives: Behavioral: Elastic Resistance Intervention in Exacerbated Patients |
| Control Group | No intervention | The patients will be evaluated on 4 phases: at the first contact (at least 24 hours after drug therapy and at most 48 hours), 7 days, 30 days and 3 months after the first contact. They will be submitted to an anamnesis, assessment of muscular strength, physical activity level, functional capacity, dyspnea on activity daily living and quality of life. Patients will be not receive intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength pre and post first contact
The effect of intervention or no intervention on muscle strength will be evaluated by the portable dynamometer (Microfet 2®, Hoggan - Health Industries, West Jordan, UT, USA). It will be positioned in front of the leg to assess quadriceps strength.
Measured: 24-48 hours after the start of exacerbation medication and 7 days after the first contact
Muscle Strength Follow-up
The benefits of intervention or no intervention on muscle strength will be evaluated by the portable dynamometer (Microfet 2®, Hoggan - Health Industries, West Jordan, UT, USA).It will be positioned in front of the leg to assess quadriceps strength 1 month after the first contact.
Measured: 1 month after the first contact
Muscle Strength Follow-up 2
The muscle strength 3 months after exacerbation will be evaluated by the portable dynamometer (Microfet 2®, Hoggan - Health Industries, West Jordan, UT, USA). It will be positioned in front of the leg to assess quadriceps strength 3 months after the first contact.
Measured: 3 months after the first contact
Secondary outcomes (3)
Physical activity level pre and post first contact
The effect of intervention or no intervention on physical activity level will be evaluated by the actigraph (activPAL3TM - PAL Technologies Ltd., Glasgow, United Kingdom) through the number of steps, time spent in different positions during 7 days.
Measured: 24-48 hours after the start of exacerbation medication and 7 days after the first contact
Physical activity level Follow-up
The benefits of intervention or no intervention on physical activity level will be evaluated by the actigraph (activPAL3TM - PAL Technologies Ltd., Glasgow, United Kingdom) through the number of steps, time spent in different positions during 7 days, 1 month after the first contact.
Measured: 1 month after the first contact
Physical activity level Follow-up 2
The physical activity level 3 months after exacerbation will be evaluated by the actigraph (activPAL3TM - PAL Technologies Ltd., Glasgow, United Kingdom) through the number of steps, time spent in different positions during 7 days, 3 months after the first contact.
Measured: 3 months after the first contact
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start7 Jun 2017 (estimated)
- Primary completion7 Aug 2017 (estimated)
- Study completion7 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Amorim Pires Di Lorenzo, Universidade Federal de Sao Carlos
- Investigators
- Valeria Di Lorenzo, PhD, Study director, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131752
- Sponsor's protocol ID
- ElastRes COPD 2016
- Status last verified
- Apr 2017
- First submitted
- 30 Mar 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.
PubMed 22807649Alison JA, McKeough ZJ. Pulmonary rehabilitation for COPD: are programs with minimal exercise equipment effective? J Thorac Dis. 2014 Nov;6(11):1606-14. doi: 10.3978/j.issn.2072-1439.2014.07.45.
PubMed 25478201Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.
PubMed 8602410Bailey PH. The dyspnea-anxiety-dyspnea cycle--COPD patients' stories of breathlessness: "It's scary /when you can't breathe". Qual Health Res. 2004 Jul;14(6):760-78. doi: 10.1177/1049732304265973.
PubMed 15200799Banzett RB, Lansing RW, Brown R, Topulos GP, Yager D, Steele SM, Londono B, Loring SH, Reid MB, Adams L, et al. 'Air hunger' from increased PCO2 persists after complete neuromuscular block in humans. Respir Physiol. 1990 Jul;81(1):1-17. doi: 10.1016/0034-5687(90)90065-7.
PubMed 2120757Bergner M. Quality of life, health status, and clinical research. Med Care. 1989 Mar;27(3 Suppl):S148-56. doi: 10.1097/00005650-198903001-00012.
PubMed 2646487Borges RC, Carvalho CR. Physical activity in daily life in Brazilian COPD patients during and after exacerbation. COPD. 2012 Dec;9(6):596-602. doi: 10.3109/15412555.2012.705364.
PubMed 23244169Eaton 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 19272084Fromer L, Cooper CB. A review of the GOLD guidelines for the diagnosis and treatment of patients with COPD. Int J Clin Pract. 2008 Aug;62(8):1219-36. doi: 10.1111/j.1742-1241.2008.01807.x. Epub 2008 Jun 28.
PubMed 18547365He M, Yu S, Wang L, Lv H, Qiu Z. Efficiency and safety of pulmonary rehabilitation in acute exacerbation of chronic obstructive pulmonary disease. Med Sci Monit. 2015 Mar 18;21:806-12. doi: 10.12659/MSM.892769.
PubMed 25783889Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
PubMed 22818936Moy ML, Wayne PM, Litrownik D, Beach D, Klings ES, Davis RB, Yeh GY. Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi. Contemp Clin Trials. 2015 Nov;45(Pt B):458-467. doi: 10.1016/j.cct.2015.09.004. Epub 2015 Sep 8.
PubMed 26362690Nguyen HQ, Chu L, Amy Liu IL, Lee JS, Suh D, Korotzer B, Yuen G, Desai S, Coleman KJ, Xiang AH, Gould MK. Associations between physical activity and 30-day readmission risk in chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Jun;11(5):695-705. doi: 10.1513/AnnalsATS.201401-017OC.
PubMed 24713094Puhan MA, Spaar A, Frey M, Turk A, Brandli O, Ritscher D, Achermann E, Kaelin R, Karrer W. Early versus late pulmonary rehabilitation in chronic obstructive pulmonary disease patients with acute exacerbations: a randomized trial. Respiration. 2012;83(6):499-506. doi: 10.1159/000329884. Epub 2011 Aug 16.
PubMed 21846962Ramos EM, de Toledo-Arruda AC, Fosco LC, Bonfim R, Bertolini GN, Guarnier FA, Cecchini R, Pastre CM, Langer D, Gosselink R, Ramos D. The effects of elastic tubing-based resistance training compared with conventional resistance training in patients with moderate chronic obstructive pulmonary disease: a randomized clinical trial. Clin Rehabil. 2014 Nov;28(11):1096-106. doi: 10.1177/0269215514527842. Epub 2014 Mar 19.
PubMed 24647863
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Pulmonary Rehabilitation With Elastic Resistance in Exacerbated COPD Patients
- ClinicalTrials.gov ID
- NCT03131752
- Acronym / sponsor ID
- ElastRes COPD 2016
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, muscle strength, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- 7 Jun 2017 (estimated)
- Primary completion
- 7 Aug 2017 (estimated)
- Study completion
- 7 Mar 2019 (estimated)
- First posted
- 27 Apr 2017 (actual)
- 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 characterized by chronic and progressive airflow limitations and subjects with COPD also experience exacerbations characterized by the worsening of respiratory symptoms. It's necessary medical intervention, changes in regular medication, and the use of antibiotics and/or corticosteroids followed or not by hospitalization. The exacerbations contribute to worsening of the disease with systemic impairment and muscle weakness is a very relevant event. The physical inactivity, especially related to bed rest, comprises one of the factors contributing to muscle atrophy and loss of muscle strength. Thus, the intervention performed during hospitalization is necessary to minimize the consequences which causes impairment in health status subjects. The aim of the study is assess the effect of the intervention with elastic bands, in muscle strength,level of the physical activity, functional capacity, dyspnea on activities of daily living (ADL) and quality of life in COPD exacerbation subjects. Moreover,verify the intervention benefits over 01 and 03 months post exacerbation episode. It will be a prospective, randomized, longitudinal and interventional study. The investigators will be asses both gender patients with exacerbation of COPD in 4 situations: First time (at least 24 and at most 48 hours after the beginning of medical therapy); seven days post the first assessment; one and three months post exacerbation episode. It will be assess the muscle strength, physical activity level, functional capacity, dyspnea on ADL and quality of life. The patients will be randomized in 2 groups: intervention and control group. The intervention will be performed with elastic bands once a day during seven days. The investigators expected that patients of the intervention group will present better muscle strength, physical activity level and functional capacity than the control group. Furthermore, an improvement in dyspnea and quality of life is expected in intervention group when compared as with control group patients. It is hypothesized that the benefits of intervention will be maintained over one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Elastic Resistance Intervention in Exacerbated PatientsThe patients will be evaluated on 4 phases: at the first contact (at least 24 hours after drug therapy and at most 48 hours), 7 days, 30 days and 3 months after the first contact. They will be submitted to an anamnesis, assessment of muscular strength, physical activity level, functional capacity, dyspnea on activity daily living and quality of life. The intervention will last 7 days for all the patients. Three phases will be performed: warm up, knee muscle strengthening with elastic bands and stretch/relax. |
| Control Group | No intervention | –The patients will be evaluated on 4 phases: at the first contact (at least 24 hours after drug therapy and at most 48 hours), 7 days, 30 days and 3 months after the first contact. They will be submitted to an anamnesis, assessment of muscular strength, physical activity level, functional capacity, dyspnea on activity daily living and quality of life. Patients will be not receive intervention. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 40 years or more, of both genders, who are in a an exacerbation of the disease according to Global Initiative for Chronic Obstructive Lung Disease (GOLD,2015) refered by the doctors, hospitalized or not in exacerbation treatment .All patients should be in spontaneous breathing at the time of assessment, in oxygen use or not and in conditions to understand the proposed evaluations; Patients who use non-invasive ventilation will also be included as long as it does not interfere with the protocols; All should agree to participate in the research in a free and informed manner. Patients who are referred to the Intensive Care Unit (ICU) may be included 24 hours after discharge from the ICU.
Key exclusion criteria (1 listed)
- Patients who present with orthopedic limitations, other pulmonary diseases, rheumatological, cardiovascular or neurological disorders that not allow the assessment. Patients whit drug os alcohol dependence, patients undergoing invasive mechanical ventilation, hemodynamic instability, the presence of unstable angina, will be excluded. In addition, patients with cognitive deficits that impair comprehension of the assessments will be excluded.
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 |
|---|---|---|
| Elastic Resistance Intervention in Exacerbated PatientsAlso: GIThe intervention protocol will performed during 7 days for all patients and this will begin 24 -48 hours after the start of medication for exacerbation. Those who are hospitalized and discharged before this period will continue their treatment at the Laboratory of Spirometry and Respiratory Physiotherapy (LEFIR) of the Federal University of São Carlos. The intervention will also perform for at least 5 continuous days. The ideal elastic band for the training will be chosen through the test of 10 maximum repetitions. The test and the training will be performed in an ergonomic chair allowing the lower limbs to remain pending. After 24 hours of the test, patients will perform knee extension exercise with the appropriate elastic band. Three sets of 10 repetitions will be done in each exercise, with a minimum rest interval of 1 minute between sets or until heart rate values return to baseline. Patients will be re-evaluated 1 and 3 months after the first contact. | Behavioural | Intervention Group |
Primary outcome
Muscle Strength pre and post first contact
Time frame: 24-48 hours after the start of exacerbation medication and 7 days after the first contact
The effect of intervention or no intervention on muscle strength will be evaluated by the portable dynamometer (Microfet 2®, Hoggan - Health Industries, West Jordan, UT, USA). It will be positioned in front of the leg to assess quadriceps strength.
Muscle Strength Follow-up
Time frame: 1 month after the first contact
The benefits of intervention or no intervention on muscle strength will be evaluated by the portable dynamometer (Microfet 2®, Hoggan - Health Industries, West Jordan, UT, USA).It will be positioned in front of the leg to assess quadriceps strength 1 month after the first contact.
Muscle Strength Follow-up 2
Time frame: 3 months after the first contact
The muscle strength 3 months after exacerbation will be evaluated by the portable dynamometer (Microfet 2®, Hoggan - Health Industries, West Jordan, UT, USA). It will be positioned in front of the leg to assess quadriceps strength 3 months after the first contact.
3 secondary outcomes
Physical activity level pre and post first contact
Time frame: 24-48 hours after the start of exacerbation medication and 7 days after the first contact
Physical activity level Follow-up
Time frame: 1 month after the first contact
Physical activity level Follow-up 2
Time frame: 3 months after the first contact
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Background: PubMed 22807649Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.
- Background: PubMed 25478201Alison JA, McKeough ZJ. Pulmonary rehabilitation for COPD: are programs with minimal exercise equipment effective? J Thorac Dis. 2014 Nov;6(11):1606-14. doi: 10.3978/j.issn.2072-1439.2014.07.45.
- Background: PubMed 8602410Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.
- Background: PubMed 15200799Bailey PH. The dyspnea-anxiety-dyspnea cycle--COPD patients' stories of breathlessness: "It's scary /when you can't breathe". Qual Health Res. 2004 Jul;14(6):760-78. doi: 10.1177/1049732304265973.
- Background: PubMed 2120757Banzett RB, Lansing RW, Brown R, Topulos GP, Yager D, Steele SM, Londono B, Loring SH, Reid MB, Adams L, et al. 'Air hunger' from increased PCO2 persists after complete neuromuscular block in humans. Respir Physiol. 1990 Jul;81(1):1-17. doi: 10.1016/0034-5687(90)90065-7.
- Background: PubMed 2646487Bergner M. Quality of life, health status, and clinical research. Med Care. 1989 Mar;27(3 Suppl):S148-56. doi: 10.1097/00005650-198903001-00012.
- Background: PubMed 23244169Borges RC, Carvalho CR. Physical activity in daily life in Brazilian COPD patients during and after exacerbation. COPD. 2012 Dec;9(6):596-602. doi: 10.3109/15412555.2012.705364.
- 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 18547365Fromer L, Cooper CB. A review of the GOLD guidelines for the diagnosis and treatment of patients with COPD. Int J Clin Pract. 2008 Aug;62(8):1219-36. doi: 10.1111/j.1742-1241.2008.01807.x. Epub 2008 Jun 28.
- Background: PubMed 25783889He M, Yu S, Wang L, Lv H, Qiu Z. Efficiency and safety of pulmonary rehabilitation in acute exacerbation of chronic obstructive pulmonary disease. Med Sci Monit. 2015 Mar 18;21:806-12. doi: 10.12659/MSM.892769.
- Background: PubMed 22818936Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
- Background: PubMed 26362690Moy ML, Wayne PM, Litrownik D, Beach D, Klings ES, Davis RB, Yeh GY. Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi. Contemp Clin Trials. 2015 Nov;45(Pt B):458-467. doi: 10.1016/j.cct.2015.09.004. Epub 2015 Sep 8.
- Individual participant dataSharing planned: No
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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.
Valeria Di Lorenzo, PhD study director
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 Elastic Resistance Intervention in Exacerbated Patients 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 1 inclusion and 1 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 27 Apr 2017. 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 Anna Claudia Sentanin, Masters (+55 (16)997328284, annasentanin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength pre and post first contact (time frame: 24-48 hours after the start of exacerbation medication and 7 days after the first contact). The study lists 3 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 NCT03131752, which also lists 17 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 27 Apr 2017.