Chronic Disease Obstructive PulmonaryNCT02783326
Rehabilitation Cardiorrespiratory Improvement in Patients With Chronic Disease Obstructive Pulmonary
A study testing Rehabilitation in people with Chronic Disease Obstructive Pulmonary, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a condition in which the lung is in chronic state due to an inflammatory response that leads to limitation in lung function of the individual, providing symptoms such as dyspnea, nutritional changes, decreased strength respiratory muscle, low capacity to exercise… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease Obstructive Pulmonary
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Jun 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals who have been diagnosed with COPD , stage II and III disease
- are undergoing treatment at the hospital João de Barros Barreto in the period January and February 2016
- both sexes
- 50 to 70 years of age
- hemodynamically stable
Who cannot join
- were not diagnosed with COPD
- present associated diseases that may interfere with cardiac autonomic control,
- had less than 50 years or over 70 years old
- are in stage I of the COPD
- in intensive care unit
- present muscle skeletal deformities
Show all 10Show fewer
- hemodynamic instability
- make use of pacemakers
- in need of supplemental O2
- who do not tolerate the practice of exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Protocol Of Rehabilitation in Patients With Chronic Disease Obstructive Pulmonary (COPD) Improvement Modulation Autonomic Heart Rate, Oxidative Stress, Quality of Life and Function
Chronic obstructive pulmonary disease (COPD) is a condition in which the lung is in chronic state due to an inflammatory response that leads to limitation in lung function of the individual, providing symptoms such as dyspnea, nutritional changes, decreased strength respiratory muscle, low capacity to exercise, dynamic insufflation and altered autonomic function with decreased heart rate variability. Have objective to evaluate and compare the effects of a rehabilitation protocol on autonomic modulation of heart rate. Participate in the study, 10 volunteers with COPD and 10 apparently healthy individuals, of both sexes, between 50 and 70 years old. Data collection and application of the Protocol will take place at the Clinical School of Physiotherapy and Occupational Therapy at the University of the Amazon (UNAMA). Between January and February 2015.
Read the detailed description
The study is being conducted in the physiotherapy clinic of HUJBB. The sample is composed of 26 volunteers with moderate to severe COPD, of both genders, recruited from the population that will start the treatment in pulmonology HUJBB physiotherapy clinic.
All participants will undergo the assessment base used in HUJBB, blood analysis, heart rate variability, AQ20 questionary, 6-minute walk test and Pulmonary Rehabilitation Program.
The evaluation will be carried out by pre-existing general assessment form and used in hospital outpatient. The sheet contains: identification data; medical history; diagnosed diseases; Drug use; Use of oxygen; nutrition and exercise habits; Physical exam; Investigations; functional kinetic evaluation; Goals; treatment/management. Since these will only be used: identification data; diagnosed diseases; Use of Oxygen; nutrition and exercise habits and goals.
Morphological assessment of EOX in blood plasma is performed according to the test known as Optical Microscopy for cell analysis in vitro or HLB test, also known under the name Dry layer oxidative test, which the investigators refer to as microscopic morphology EOX in plasma (EEW). The EEW provides indirect information concerning EOX, among others, using the following grading system percentage of discontinuous area of the clot, present in the microscope slide: grade I (normal EOX rate, with total area of discontinuity of the extracellular matrix (ME) less than 10%), grade II (light EOX with ME discontinuity area between 10 to 20%), grade III (moderate EOX with ME discontinuity area between 20 to 30%), grade IV ( serious EOX with ME discontinuity area between 30 to 40%) and the grade V (very serious EOX with ME discontinuity area above 40%) 18. By lancing on the medial side of the digital pulp of the fourth finger of the left hand previously sanitized with alcohol, collecting the blood drop will be next to a microscope slide by five light touches this blade with the drop. After this procedure, the blade will be kept in place protected from contact with the blood and at room temperature (23 ° C) for the nine-minute period for the realization of the collected blood clotting process. At the end of this period, the morphological patterns of these clots are seen in an increase of 40 times as set out in protocolo18 and their assigned qualitative graduation will be logged into a spreadsheet for further statistical analysis.
The coagulated blood will be studied by Videomicroscopy (microscope NIPOM brand), which will be selected the best histological field, then a picture which will be analyzed by Image Pro Plus you see the fields where there is no blood coagulation will be made, and from this discontinuity the program will provide the percentage of oxidative stress. This analysis test allows you to have an indirect notion of oxidative stress level in the studied patient and to evaluate its therapeutic development.
The uptake of HRV is performed via a heart rate monitor Polar ® brand of, RS800CX model where the FC signal is received by a strap to the signal receiver which is placed in the voluntary thorax at the level of the xiphoid the sternum. This funding is recorded in the Polar RS800CX monitor and transferred to the Software Polar ProTrainer program through a broadcast interface infrared signals, which are stored and subsequently exported to txt format so that later can be analyzed by a mathematical routine in Kubios HRV program. In the program will be selected 5 minutes from the passage that has better signal stability.
HRV will be analyzed at rest in the supine position. This test is to evaluate the variability of the heart rate response to check the modulation of autonomic control over it at rest in the supine position.
Volunteers will be asked to remain at rest for a period of 10 minutes, avoiding talking to the researcher so that the heart rate does not undergo changes. Then will begin the collection of heart rate with duration of 10 minutes in the supine position while maintaining spontaneous breathing.
The AQ20 is applied twice to the same patient, once in the first day and a second time after the end of the program. Only two researchers participated in the questionnaire.
The hall used to perform the 6MWT should have a comfortable temperature, and can be a closed or outdoor environment, since it is flat, and little traveled so there are no interruptions while walking by people who move there. Usually you use a corridor 30 meters long, with no obstacles where the time to make a turn must be marked with a cone. The test objective is to walk in itself alone pace as far as possible during the six minutes and guiding possible cardiorespiratory changes that may arise, being allowed to walk slowly, stop, relax when needed returning to walk when you feel able to resume the walk. You must walk without talking to the people who are around you to the cone and will back quickly around it so continuing to walk without hesitation. The path must be shown to the patient by the examiner and can start walking.
The training will run 2 times a week (Monday and Wednesday or Tuesday and Thursday ), lasting approximately 50 minutes of specific training ( aerobic and strengthening), for 10 weeks, making a total of 20 days of exercise.
During this period volunteers will be told not to perform complementary physical activities and/or addition to another rehabilitation program.
strengthening exercises involve large muscle groups of the regions of the shoulder, knee and hip in closed and open chain using the Neuromuscular Facilitation ( PNF) with upper extremity exercises within the movements of the diagonals of Kabat method (flexion -adduction -rotation external / foreign flexion - abduction -rotation / internal extension - abduction - rotation / internal extension - adduction - rotation ). The exercises follow the protocol 3 sets of 10 repetitions at intervals of 30 seconds of rest.
- Conditions
- Chronic Disease Obstructive Pulmonary
- Being tested
- Rehabilitation
- Keywords
- Chronic Disease Obstructive Pulmonary, Rehabilitation, 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.
RehabilitationOther
Pulmonary rehabilitation, exercise in COPD individuals and health individuals
| Study group | Role | What they receive |
|---|---|---|
| COPD Group | Experimental | Evaluation of oxidative stress, heart rate variability, quality of life with AQ20 questionary, function with TC6 before the application of rehabilitation protocol, after 10 weeks during protocol application and 2 months after protocol application Receives: Other: Rehabilitation |
| Control Group | Active comparator | Evaluation of oxidative stress, heart rate variability, quality of life with AQ20 questionary, function with TC6 before the application of rehabilitation protocol, after 10 weeks during protocol application and 2 months after protocol application Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability modulation
Heart rate variability evaluation
Measured: Change from baseline autonomic modulation at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Disease Obstructive PulmonaryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba
- Investigators
- Rodrigo S Rocha, Master, Principal investigator, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783326
- Sponsor's protocol ID
- 1322578
- Status last verified
- Nov 2018
- First submitted
- 11 Mar 2016
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Borghi-Silva A, Arena R, Castello V, Simoes RP, Martins LE, Catai AM, Costa D. Aerobic exercise training improves autonomic nervous control in patients with COPD. Respir Med. 2009 Oct;103(10):1503-10. doi: 10.1016/j.rmed.2009.04.015. Epub 2009 May 22.
PubMed 19464865Fischer BM, Pavlisko E, Voynow JA. Pathogenic triad in COPD: oxidative stress, protease-antiprotease imbalance, and inflammation. Int J Chron Obstruct Pulmon Dis. 2011;6:413-21. doi: 10.2147/COPD.S10770. Epub 2011 Aug 5.
PubMed 21857781Decramer M. Response of the respiratory muscles to rehabilitation in COPD. J Appl Physiol (1985). 2009 Sep;107(3):971-6. doi: 10.1152/japplphysiol.91459.2008. Epub 2009 Apr 2.
PubMed 19342436Pelegrino NR, Lucheta PA, Sanchez FF, Faganello MM, Ferrari R, Godoy Id. Influence of lean body mass on cardiopulmonary repercussions during the six-minute walk test in patients with COPD. J Bras Pneumol. 2009 Jan;35(1):20-6. doi: 10.1590/s1806-37132009000100004. English, Portuguese.
PubMed 19219327Eisner MD, Blanc PD, Sidney S, Yelin EH, Lathon PV, Katz PP, Tolstykh I, Ackerson L, Iribarren C. Body composition and functional limitation in COPD. Respir Res. 2007 Jan 29;8(1):7. doi: 10.1186/1465-9921-8-7.
PubMed 17261190
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Protocol Of Rehabilitation in Patients With Chronic Disease Obstructive Pulmonary (COPD) Improvement Modulation Autonomic Heart Rate, Oxidative Stress, Quality of Life and Function
- ClinicalTrials.gov ID
- NCT02783326
- Acronym / sponsor ID
- 1322578
- Conditions
- Chronic Disease Obstructive Pulmonary
- Keywords
- Chronic Disease Obstructive Pulmonary, Rehabilitation, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 May 2016 (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 a condition in which the lung is in chronic state due to an inflammatory response that leads to limitation in lung function of the individual, providing symptoms such as dyspnea, nutritional changes, decreased strength respiratory muscle, low capacity to exercise, dynamic insufflation and altered autonomic function with decreased heart rate variability. Have objective to evaluate and compare the effects of a rehabilitation protocol on autonomic modulation of heart rate. Participate in the study, 10 volunteers with COPD and 10 apparently healthy individuals, of both sexes, between 50 and 70 years old. Data collection and application of the Protocol will take place at the Clinical School of Physiotherapy and Occupational Therapy at the University of the Amazon (UNAMA). Between January and February 2015.
Detailed description
The study is being conducted in the physiotherapy clinic of HUJBB. The sample is composed of 26 volunteers with moderate to severe COPD, of both genders, recruited from the population that will start the treatment in pulmonology HUJBB physiotherapy clinic.
All participants will undergo the assessment base used in HUJBB, blood analysis, heart rate variability, AQ20 questionary, 6-minute walk test and Pulmonary Rehabilitation Program.
The evaluation will be carried out by pre-existing general assessment form and used in hospital outpatient. The sheet contains: identification data; medical history; diagnosed diseases; Drug use; Use of oxygen; nutrition and exercise habits; Physical exam; Investigations; functional kinetic evaluation; Goals; treatment/management. Since these will only be used: identification data; diagnosed diseases; Use of Oxygen; nutrition and exercise habits and goals.
Morphological assessment of EOX in blood plasma is performed according to the test known as Optical Microscopy for cell analysis in vitro or HLB test, also known under the name Dry layer oxidative test, which the investigators refer to as microscopic morphology EOX in plasma (EEW). The EEW provides indirect information concerning EOX, among others, using the following grading system percentage of discontinuous area of the clot, present in the microscope slide: grade I (normal EOX rate, with total area of discontinuity of the extracellular matrix (ME) less than 10%), grade II (light EOX with ME discontinuity area between 10 to 20%), grade III (moderate EOX with ME discontinuity area between 20 to 30%), grade IV ( serious EOX with ME discontinuity area between 30 to 40%) and the grade V (very serious EOX with ME discontinuity area above 40%) 18. By lancing on the medial side of the digital pulp of the fourth finger of the left hand previously sanitized with alcohol, collecting the blood drop will be next to a microscope slide by five light touches this blade with the drop. After this procedure, the blade will be kept in place protected from contact with the blood and at room temperature (23 ° C) for the nine-minute period for the realization of the collected blood clotting process. At the end of this period, the morphological patterns of these clots are seen in an increase of 40 times as set out in protocolo18 and their assigned qualitative graduation will be logged into a spreadsheet for further statistical analysis.
The coagulated blood will be studied by Videomicroscopy (microscope NIPOM brand), which will be selected the best histological field, then a picture which will be analyzed by Image Pro Plus you see the fields where there is no blood coagulation will be made, and from this discontinuity the program will provide the percentage of oxidative stress. This analysis test allows you to have an indirect notion of oxidative stress level in the studied patient and to evaluate its therapeutic development.
The uptake of HRV is performed via a heart rate monitor Polar ® brand of, RS800CX model where the FC signal is received by a strap to the signal receiver which is placed in the voluntary thorax at the level of the xiphoid the sternum. This funding is recorded in the Polar RS800CX monitor and transferred to the Software Polar ProTrainer program through a broadcast interface infrared signals, which are stored and subsequently exported to txt format so that later can be analyzed by a mathematical routine in Kubios HRV program. In the program will be selected 5 minutes from the passage that has better signal stability.
HRV will be analyzed at rest in the supine position. This test is to evaluate the variability of the heart rate response to check the modulation of autonomic control over it at rest in the supine position.
Volunteers will be asked to remain at rest for a period of 10 minutes, avoiding talking to the researcher so that the heart rate does not undergo changes. Then will begin the collection of heart rate with duration of 10 minutes in the supine position while maintaining spontaneous breathing.
The AQ20 is applied twice to the same patient, once in the first day and a second time after the end of the program. Only two researchers participated in the questionnaire.
The hall used to perform the 6MWT should have a comfortable temperature, and can be a closed or outdoor environment, since it is flat, and little traveled so there are no interruptions while walking by people who move there. Usually you use a corridor 30 meters long, with no obstacles where the time to make a turn must be marked with a cone. The test objective is to walk in itself alone pace as far as possible during the six minutes and guiding possible cardiorespiratory changes that may arise, being allowed to walk slowly, stop, relax when needed returning to walk when you feel able to resume the walk. You must walk without talking to the people who are around you to the cone and will back quickly around it so continuing to walk without hesitation. The path must be shown to the patient by the examiner and can start walking.
The training will run 2 times a week (Monday and Wednesday or Tuesday and Thursday ), lasting approximately 50 minutes of specific training ( aerobic and strengthening), for 10 weeks, making a total of 20 days of exercise.
During this period volunteers will be told not to perform complementary physical activities and/or addition to another rehabilitation program.
strengthening exercises involve large muscle groups of the regions of the shoulder, knee and hip in closed and open chain using the Neuromuscular Facilitation ( PNF) with upper extremity exercises within the movements of the diagonals of Kabat method (flexion -adduction -rotation external / foreign flexion - abduction -rotation / internal extension - abduction - rotation / internal extension - adduction - rotation ). The exercises follow the protocol 3 sets of 10 repetitions at intervals of 30 seconds of rest.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Group | Experimental | Other: RehabilitationEvaluation of oxidative stress, heart rate variability, quality of life with AQ20 questionary, function with TC6 before the application of rehabilitation protocol, after 10 weeks during protocol application and 2 months after protocol application |
| Control Group | Active comparator | Other: RehabilitationEvaluation of oxidative stress, heart rate variability, quality of life with AQ20 questionary, function with TC6 before the application of rehabilitation protocol, after 10 weeks during protocol application and 2 months after protocol application |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- individuals who have been diagnosed with COPD , stage II and III disease
- are undergoing treatment at the hospital João de Barros Barreto in the period January and February 2016
- both sexes
- 50 to 70 years of age
- hemodynamically stable
Key exclusion criteria (10 listed)
- were not diagnosed with COPD
- present associated diseases that may interfere with cardiac autonomic control,
- had less than 50 years or over 70 years old
- are in stage I of the COPD
- in intensive care unit
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 |
|---|---|---|
| RehabilitationPulmonary rehabilitation, exercise in COPD individuals and health individuals | Other | COPD Group, Control Group |
Primary outcome
Heart rate variability modulation
Time frame: Change from baseline autonomic modulation at 2 months
Heart rate variability evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Results publication: PubMed 19464865Borghi-Silva A, Arena R, Castello V, Simoes RP, Martins LE, Catai AM, Costa D. Aerobic exercise training improves autonomic nervous control in patients with COPD. Respir Med. 2009 Oct;103(10):1503-10. doi: 10.1016/j.rmed.2009.04.015. Epub 2009 May 22.
- Results publication: PubMed 21857781Fischer BM, Pavlisko E, Voynow JA. Pathogenic triad in COPD: oxidative stress, protease-antiprotease imbalance, and inflammation. Int J Chron Obstruct Pulmon Dis. 2011;6:413-21. doi: 10.2147/COPD.S10770. Epub 2011 Aug 5.
- Results publication: PubMed 19342436Decramer M. Response of the respiratory muscles to rehabilitation in COPD. J Appl Physiol (1985). 2009 Sep;107(3):971-6. doi: 10.1152/japplphysiol.91459.2008. Epub 2009 Apr 2.
- Results publication: PubMed 19219327Pelegrino NR, Lucheta PA, Sanchez FF, Faganello MM, Ferrari R, Godoy Id. Influence of lean body mass on cardiopulmonary repercussions during the six-minute walk test in patients with COPD. J Bras Pneumol. 2009 Jan;35(1):20-6. doi: 10.1590/s1806-37132009000100004. English, Portuguese.
- Results publication: PubMed 17261190Eisner MD, Blanc PD, Sidney S, Yelin EH, Lathon PV, Katz PP, Tolstykh I, Ackerson L, Iribarren C. Body composition and functional limitation in COPD. Respir Res. 2007 Jan 29;8(1):7. doi: 10.1186/1465-9921-8-7.
- 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.
Rodrigo S Rocha, Master principal investigator
Universidade Metodista de Piracicaba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Chronic Disease Obstructive Pulmonary, run by Universidade Metodista de Piracicaba 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 21 Nov 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability modulation (time frame: Change from baseline autonomic modulation at 2 months). 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 NCT02783326, which also lists 5 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 Nov 2018.