Cardiac Valve DiseaseNCT02657109
Influence of a Rehabilitation in Valve Replacement on Heart Rate Variability and Oxidative Stress
A study testing physical therapy procedure in people with Cardiac Valve Disease, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
4 consecutive days with volunteers between the first and fourth postoperative period of cardiac valve replacement. The volunteers are randomized into 2 groups: the Control Group submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the study, which consists of respiratory and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiac Valve Disease
- What is being tested?
- physical therapy procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Jul 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteers underwent cardiac valve replacement surgery
- Using median sternotomy
- Aged 30 60 years
- Pulse saturation greater than 90%
- BMI ranging between 18.5 and 25 kg / m2
Who cannot join
- Less than 30 years or over 60 years of age
- Other type of heart surgery than valve replacement, as well valve re-replacement
- Unconscious and level of the Glasgow Coma below scale 15
- Cardiac arrhythmias
- With electrolyte disturbances
- With pleural diseases such as pneumothorax, empyema or pleural effusion
Show all 10Show fewer
- Circulatory failure acute
- Infections in either system
- Patients with coagulation disorders
- Pulse oxygen saturation lower than 90% even with supplementary oxygen therapy - Hemodynamically unstable supply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Early Mobilization Protocol in Heart Valve Replacement on Heart Rate Variability and Oxidative Stress
4 consecutive days with volunteers between the first and fourth postoperative period of cardiac valve replacement. The volunteers are randomized into 2 groups: the Control Group submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the study, which consists of respiratory and metabolic exercises. The second group, called Early Mobilization Group in addition to the aforementioned exercises will be added exercise in cycle ergometer. For the implementation of rehabilitation protocol in the early mobilization group volunteers will be placed in a sitting position in the bed with the backrest raised to 45 °. The exercise in cycle ergometer will be held for 20 minutes on four consecutive days of active mode, the training load shall be such that the voluntary maintained throughout training a level of fatigue, maintaining level of heart rate predicted for age increased by 70% and 1 w / cm2 every minute to keep the parameter within the standards. The evaluation of heart rate variability with the Polar monitor RS800CX brand model before surgery was performed first postoperative day and fifth postoperative day in the control groups and early mobilization.
Read the detailed description
The valve disorders are a special group of heart diseases with long period without clinical manifestations, when there is the appearance of symptoms, the patient is a likely candidate for surgery. In many surgical complications can occur, including the respiratory cause and immobility in bed culminating in the need for intensive care. Early mobilization exercises conducted by physical therapy in critically ill patients is to minimize complications related to immobility in bed from surgery that is performed in exchanges of heart valves. To investigate the influence of a cardiac rehabilitation program on cardiac function (Heart Rate Varibility) and free radicals (oxidative stress) in patients undergoing surgical heart valve replacement. The study is being conducted at the Clinical Hospital Gaspar Viana of Belém, in March 2014 period to March 2016, with the proposing institution the Methodist University of Piracicaba. The study included 60 volunteers aged 18 to 60 year old male with surgery scheduling of heart valve replacement. The volunteers were divided into 2 groups the control group who underwent rehabilitation proposed by the hospital with simple exercises like deep breathing exercises to improve cough, move your arms and rhythmically legs to maintain joint mobility, the second group It was called Early Mobilization Group, where volunteers beyond rehabilitation protocol proposed by the hospital, held exercises in a cycle ergometer, The volunteers were instructed to pedal lying comfortably with moderate intensity for 30 minutes. All groups performed this protocol lasting 4 days. Oxidative stress was analyzed and cardiac function before surgery, after surgery in the first and fifth postoperative. The Oxidative Stress is analyzed by puncturing a drop of blood and to analyze the photographed area coagulum formed. Cardiac function (Heart Rate Variability) will be analyzed using a heart rate monitor brand Polar® RS800CX model being evaluated lying down, then the data is transferred to the computer and analyzed in a program called Kubios HRV. After collecting the data will be analyzed in Biostat 5.2 program. The possible risks to the research subject is the inconvenience of collecting the blood sample, the onset of pain resulting from the mobilization of the rehabilitation protocol. However, the emergence of at least one of the risks mentioned above, the procedure and / or service must be stopped and perform passive stretching or temporary home until everything returns to normal. In addition, there may be a risk of contamination to volunteer for collecting blood, however this risk is minimized when using materials such as sterile needles and blades. The research brings benefit as increased range of motion and muscle strength, decreased pain, functional improvement, providing improvement in quality of life and functional independence and reduced hospital stay.
- Conditions
- Cardiac Valve Disease
- Being tested
- physical therapy procedure
- Keywords
- valve replacement, physical therapy, early mobilization
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy procedureOther
Also called early mobilization
physiotherapy exercises conducted in early way for the rehabilitation of patients in the postoperative period of cardiac valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants are submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the study, which consists in respiratory exercises of 3 series Inspirations Maximum Sustained for 10 reps, 3 sets of 20 repetitions metabolic exercises with dorsiflexion and plantar flexion and ankle and wrist extension and fingers of the upper limbs. Assessment of heart rate varibility and oxidative stress carried out before the heart valve replacement surgery , the first day of postoperative and on the fifth postoperative day Receives: Other: physical therapy procedure |
| Early mobilization | Active comparator | Participants performed exercise in cycle ergometer of lower Limbs, pedaling for 20 consecutive minutes at a moderate level with Heart Rate Assessment and the Borg scale to evaluate the Voluntary Comfort. Assessment of heart rate varibility and oxidative stress carried out before the heart valve replacement surgery , the first day of oepratório post and on the fifth postoperative day Receives: Other: physical therapy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
It will be analyzed the uptake of heart rate variability by means of the heart rate monitor Polar ® brand, model RS800CX where FC signal is received by a strap to the signal receiver, to be placed on the thorax at the level of voluntary xiphoid process. This capture is stored in the Polar monitor and transferred to the software Polar ProTrainer program by means of an emission of infrared signals interface, where they are stored and subsequently exported to TXT format, which subsequently can be analyzed by a math routine in Kubios HRV® program. Volunteers will be asked to remain at rest for a period of 10 min, avoiding talking to the researcher so that the heart rate does not undergo changes.
Measured: one hour
Oxidative stress
Morphological evaluation of oxidative stress in the blood plasma is performed by the so called Optical Microscopy Test for In Vitro Analysis Cell or HLB Test. The fingertip of the fourth finger of the previously sanitized hand with alcohol, will collect a drop of blood next to a microscope slide through five light touch of this blade next to the drop .
At the end of this period, the morphology of this clot is microscopically observed under a 40-fold increase in optical microscope brand Nikon® model Binocular E200 Standard and its qualitative graduation will be recorded by the camera attached Nikon® mark on a spreadsheet to later analysis. The observation of morphological patterns of the different obtained clots will be held in the first image taken on each of the blades and the evaluation will be conducted through the program called OxyScanner® developed and marketed by Aldea Global Soluciones (AGS).
Measured: one hour
Secondary outcomes (1)
Hospitalization time evaluation
investigate the volunteers of stay in both intervention groups using evaluation of the patients medical records
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cardiac Valve 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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 Batagello, PHD, Study director, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657109
- Sponsor's protocol ID
- 37/2014
- Status last verified
- Dec 2018
- First submitted
- 11 Jan 2016
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data of the volunteers will be kept confidential , being only used the amount of data for publication in journals with the period until 2017
Publications
Laitio TT, Huikuri HV, Koskenvuo J, Jalonen J, Makikallio TH, Helenius H, Kentala ES, Hartiala J, Scheinin H. Long-term alterations of heart rate dynamics after coronary artery bypass graft surgery. Anesth Analg. 2006 Apr;102(4):1026-31. doi: 10.1213/01.ane.0000198674.90500.59.
PubMed 16551892Brasher PA, McClelland KH, Denehy L, Story I. Does removal of deep breathing exercises from a physiotherapy program including pre-operative education and early mobilisation after cardiac surgery alter patient outcomes? Aust J Physiother. 2003;49(3):165-73. doi: 10.1016/s0004-9514(14)60236-1.
PubMed 12952516Burtin 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 19623052Aubert AE, Seps B, Beckers F. Heart rate variability in athletes. Sports Med. 2003;33(12):889-919. doi: 10.2165/00007256-200333120-00003.
PubMed 12974657Karemaker JM, Lie KI. Heart rate variability: a telltale of health or disease. Eur Heart J. 2000 Mar;21(6):435-7. doi: 10.1053/euhj.1999.1969. No abstract available.
PubMed 10681483Sachdev S, Davies KJ. Production, detection, and adaptive responses to free radicals in exercise. Free Radic Biol Med. 2008 Jan 15;44(2):215-23. doi: 10.1016/j.freeradbiomed.2007.07.019. Epub 2007 Jul 31.
PubMed 18191757Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
PubMed 8598068Truong AD, Fan E, Brower RG, Needham DM. Bench-to-bedside review: mobilizing patients in the intensive care unit--from pathophysiology to clinical trials. Crit Care. 2009;13(4):216. doi: 10.1186/cc7885. Epub 2009 Jul 13.
PubMed 19664166Silva AP, Maynard K, Cruz MR. Effects of motor physical therapy in critically ill patients: literature review. Rev Bras Ter Intensiva. 2010 Mar;22(1):85-91. English, Portuguese.
PubMed 25303704Vaishnav S, Stevenson R, Marchant B, Lagi K, Ranjadayalan K, Timmis AD. Relation between heart rate variability early after acute myocardial infarction and long-term mortality. Am J Cardiol. 1994 Apr 1;73(9):653-7. doi: 10.1016/0002-9149(94)90928-8.
PubMed 8166060Wright DJ, Williams SG, Riley R, Marshall P, Tan LB. Is early, low level, short term exercise cardiac rehabilitation following coronary bypass surgery beneficial? A randomised controlled trial. Heart. 2002 Jul;88(1):83-4. doi: 10.1136/heart.88.1.83. No abstract available.
PubMed 12067954Zafiropoulos B, Alison JA, McCarren B. Physiological responses to the early mobilisation of the intubated, ventilated abdominal surgery patient. Aust J Physiother. 2004;50(2):95-100. doi: 10.1016/s0004-9514(14)60101-x.
PubMed 15151493
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Early Mobilization Protocol in Heart Valve Replacement on Heart Rate Variability and Oxidative Stress
- ClinicalTrials.gov ID
- NCT02657109
- Acronym / sponsor ID
- 37/2014
- Conditions
- Cardiac Valve Disease
- Keywords
- valve replacement, physical therapy, early mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 15 Jan 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.
4 consecutive days with volunteers between the first and fourth postoperative period of cardiac valve replacement. The volunteers are randomized into 2 groups: the Control Group submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the study, which consists of respiratory and metabolic exercises. The second group, called Early Mobilization Group in addition to the aforementioned exercises will be added exercise in cycle ergometer. For the implementation of rehabilitation protocol in the early mobilization group volunteers will be placed in a sitting position in the bed with the backrest raised to 45 °. The exercise in cycle ergometer will be held for 20 minutes on four consecutive days of active mode, the training load shall be such that the voluntary maintained throughout training a level of fatigue, maintaining level of heart rate predicted for age increased by 70% and 1 w / cm2 every minute to keep the parameter within the standards. The evaluation of heart rate variability with the Polar monitor RS800CX brand model before surgery was performed first postoperative day and fifth postoperative day in the control groups and early mobilization.
Detailed description
The valve disorders are a special group of heart diseases with long period without clinical manifestations, when there is the appearance of symptoms, the patient is a likely candidate for surgery. In many surgical complications can occur, including the respiratory cause and immobility in bed culminating in the need for intensive care. Early mobilization exercises conducted by physical therapy in critically ill patients is to minimize complications related to immobility in bed from surgery that is performed in exchanges of heart valves. To investigate the influence of a cardiac rehabilitation program on cardiac function (Heart Rate Varibility) and free radicals (oxidative stress) in patients undergoing surgical heart valve replacement. The study is being conducted at the Clinical Hospital Gaspar Viana of Belém, in March 2014 period to March 2016, with the proposing institution the Methodist University of Piracicaba. The study included 60 volunteers aged 18 to 60 year old male with surgery scheduling of heart valve replacement. The volunteers were divided into 2 groups the control group who underwent rehabilitation proposed by the hospital with simple exercises like deep breathing exercises to improve cough, move your arms and rhythmically legs to maintain joint mobility, the second group It was called Early Mobilization Group, where volunteers beyond rehabilitation protocol proposed by the hospital, held exercises in a cycle ergometer, The volunteers were instructed to pedal lying comfortably with moderate intensity for 30 minutes. All groups performed this protocol lasting 4 days. Oxidative stress was analyzed and cardiac function before surgery, after surgery in the first and fifth postoperative. The Oxidative Stress is analyzed by puncturing a drop of blood and to analyze the photographed area coagulum formed. Cardiac function (Heart Rate Variability) will be analyzed using a heart rate monitor brand Polar® RS800CX model being evaluated lying down, then the data is transferred to the computer and analyzed in a program called Kubios HRV. After collecting the data will be analyzed in Biostat 5.2 program. The possible risks to the research subject is the inconvenience of collecting the blood sample, the onset of pain resulting from the mobilization of the rehabilitation protocol. However, the emergence of at least one of the risks mentioned above, the procedure and / or service must be stopped and perform passive stretching or temporary home until everything returns to normal. In addition, there may be a risk of contamination to volunteer for collecting blood, however this risk is minimized when using materials such as sterile needles and blades. The research brings benefit as increased range of motion and muscle strength, decreased pain, functional improvement, providing improvement in quality of life and functional independence and reduced hospital stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: physical therapy procedureParticipants are submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the study, which consists in respiratory exercises of 3 series Inspirations Maximum Sustained for 10 reps, 3 sets of 20 repetitions metabolic exercises with dorsiflexion and plantar flexion and ankle and wrist extension and fingers of the upper limbs. Assessment of heart rate varibility and oxidative stress carried out before the heart valve replacement surgery , the first day of postoperative and on the fifth postoperative day |
| Early mobilization | Active comparator | Other: physical therapy procedureParticipants performed exercise in cycle ergometer of lower Limbs, pedaling for 20 consecutive minutes at a moderate level with Heart Rate Assessment and the Borg scale to evaluate the Voluntary Comfort. Assessment of heart rate varibility and oxidative stress carried out before the heart valve replacement surgery , the first day of oepratório post and on the fifth postoperative day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteers underwent cardiac valve replacement surgery
- Using median sternotomy
- Aged 30 60 years
- Pulse saturation greater than 90%
- BMI ranging between 18.5 and 25 kg / m2
Key exclusion criteria (10 listed)
- Less than 30 years or over 60 years of age
- Other type of heart surgery than valve replacement, as well valve re-replacement
- Unconscious and level of the Glasgow Coma below scale 15
- Cardiac arrhythmias
- With electrolyte disturbances
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 |
|---|---|---|
| physical therapy procedureAlso: early mobilizationphysiotherapy exercises conducted in early way for the rehabilitation of patients in the postoperative period of cardiac valve replacement. | Other | Control, Early mobilization |
Primary outcome
Heart Rate Variability
Time frame: one hour
It will be analyzed the uptake of heart rate variability by means of the heart rate monitor Polar ® brand, model RS800CX where FC signal is received by a strap to the signal receiver, to be placed on the thorax at the level of voluntary xiphoid process. This capture is stored in the Polar monitor and transferred to the software Polar ProTrainer program by means of an emission of infrared signals interface, where they are stored and subsequently exported to TXT format, which subsequently can be analyzed by a math routine in Kubios HRV® program. Volunteers will be asked to remain at rest for a period of 10 min, avoiding talking to the researcher so that the heart rate does not undergo changes.
Oxidative stress
Time frame: one hour
Morphological evaluation of oxidative stress in the blood plasma is performed by the so called Optical Microscopy Test for In Vitro Analysis Cell or HLB Test. The fingertip of the fourth finger of the previously sanitized hand with alcohol, will collect a drop of blood next to a microscope slide through five light touch of this blade next to the drop . At the end of this period, the morphology of this clot is microscopically observed under a 40-fold increase in optical microscope brand Nikon® model Binocular E200 Standard and its qualitative graduation will be recorded by the camera attached Nikon® mark on a spreadsheet to later analysis. The observation of morphological patterns of the different obtained clots will be held in the first image taken on each of the blades and the evaluation will be conducted through the program called OxyScanner® developed and marketed by Aldea Global Soluciones (AGS).
1 secondary outcome
Hospitalization time evaluation
Time frame: 1 month
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 5 Dec 2018.
- Background: PubMed 16551892Laitio TT, Huikuri HV, Koskenvuo J, Jalonen J, Makikallio TH, Helenius H, Kentala ES, Hartiala J, Scheinin H. Long-term alterations of heart rate dynamics after coronary artery bypass graft surgery. Anesth Analg. 2006 Apr;102(4):1026-31. doi: 10.1213/01.ane.0000198674.90500.59.
- Results publication: PubMed 12952516Brasher PA, McClelland KH, Denehy L, Story I. Does removal of deep breathing exercises from a physiotherapy program including pre-operative education and early mobilisation after cardiac surgery alter patient outcomes? Aust J Physiother. 2003;49(3):165-73. doi: 10.1016/s0004-9514(14)60236-1.
- Results publication: 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.
- Results publication: PubMed 12974657Aubert AE, Seps B, Beckers F. Heart rate variability in athletes. Sports Med. 2003;33(12):889-919. doi: 10.2165/00007256-200333120-00003.
- Results publication: PubMed 10681483Karemaker JM, Lie KI. Heart rate variability: a telltale of health or disease. Eur Heart J. 2000 Mar;21(6):435-7. doi: 10.1053/euhj.1999.1969. No abstract available.
- Results publication: PubMed 18191757Sachdev S, Davies KJ. Production, detection, and adaptive responses to free radicals in exercise. Free Radic Biol Med. 2008 Jan 15;44(2):215-23. doi: 10.1016/j.freeradbiomed.2007.07.019. Epub 2007 Jul 31.
- Results publication: PubMed 8598068Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Results publication: PubMed 19664166Truong AD, Fan E, Brower RG, Needham DM. Bench-to-bedside review: mobilizing patients in the intensive care unit--from pathophysiology to clinical trials. Crit Care. 2009;13(4):216. doi: 10.1186/cc7885. Epub 2009 Jul 13.
- Results publication: PubMed 25303704Silva AP, Maynard K, Cruz MR. Effects of motor physical therapy in critically ill patients: literature review. Rev Bras Ter Intensiva. 2010 Mar;22(1):85-91. English, Portuguese.
- Results publication: PubMed 8166060Vaishnav S, Stevenson R, Marchant B, Lagi K, Ranjadayalan K, Timmis AD. Relation between heart rate variability early after acute myocardial infarction and long-term mortality. Am J Cardiol. 1994 Apr 1;73(9):653-7. doi: 10.1016/0002-9149(94)90928-8.
- Results publication: PubMed 12067954Wright DJ, Williams SG, Riley R, Marshall P, Tan LB. Is early, low level, short term exercise cardiac rehabilitation following coronary bypass surgery beneficial? A randomised controlled trial. Heart. 2002 Jul;88(1):83-4. doi: 10.1136/heart.88.1.83. No abstract available.
- Results publication: PubMed 15151493Zafiropoulos B, Alison JA, McCarren B. Physiological responses to the early mobilisation of the intubated, ventilated abdominal surgery patient. Aust J Physiother. 2004;50(2):95-100. doi: 10.1016/s0004-9514(14)60101-x.
- Individual participant dataSharing planned: Yes. The data of the volunteers will be kept confidential , being only used the amount of data for publication in journals with the period until 2017
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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 Batagello, PHD study director
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 physical therapy procedure in people with Cardiac Valve Disease, 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 5 Dec 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 (time frame: one hour). 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 NCT02657109, which also lists 12 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 5 Dec 2018.