Cardiovascular DiseasesNCT02109055
Application of Exercises Based on the Pilates in Coronary Artery Bypass Grafting
A study testing Pilates and Conventional Physiotherapy in people with Cardiovascular Diseases, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The major cause of mortality worldwide is due to cardiovascular diseases. A way to treat these diseases is coronary artery bypass grafting, one of the most common surgical procedures in the world. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Pilates and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Apr 2015
- 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
- Individuals in postoperative coronary artery bypass grafting, extubated within 24 hours after surgery, hemodynamically stable, with no ischemic changes and/or complex arrhythmias on electrocardiogram e who have performed the first surgery and surgery alone.
Who cannot join
- Patients with decompensated heart failure, presence of any comorbidity, such as unstable angina, associated neurological disease, moderate to severe respiratory illness prior diagnosed by the attending physician, acute respiratory dysfunction in the post - operative, active infectious disease or fever; vascular disease disabling peripheral, unstable ventricular arrhythmia; musculoskeletal disease that limits the practice of Pilates will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Rodrigo Della Méa Plentz
Porto Alegre, Rio Grande do Sul, 90050170
Manoela Heinrichs, +55 (051)91330208, manoelaheinrichs@yahoo.com.br
Manoela Heinrichs
About this study
Official title: Application of Exercises Based on the Pilates Method on the Functional Capacity in Postoperative Surgery Coronery Artery Bypass Grafting: Randomized Clinical Trial
The major cause of mortality worldwide is due to cardiovascular diseases. A way to treat these diseases is coronary artery bypass grafting, one of the most common surgical procedures in the world. The incidence of post-operative complications contributes to functional decline of the patient, reduced quality of life and post-discharge mortality. Also, cardiac surgery leads to changes in lung capacity and respiratory muscle strength, causing a decrease in the function lung. Physical therapy proves to be an effective tool to combat changes resulting from cardiac surgery, demonstrating beneficial results in the pulmonary function, functional capacity, and peripheral and respiratory muscle strength. The Pilates method has been studied as a therapeutic way to healthy subjects and various kinds of diseases, but there are no studies in the literature evaluating the effect method in patients after coronary artery bypass surgery.
The aim of this study is to investigate the effect of Pilates on functional capacity , flows and lung volumes, respiratory and peripheral muscle strength after coronary artery bypass grafting.
Read more
Randomized clinical trial in which patients will be eligible after elective coronary artery bypass surgery, randomly allocated into two groups : conventional physiotherapy group (n = 15) and Pilates method associated with conventional physiotherapy group (n = 15). The outcomes will be assessed by blinded evaluator and data randomization will be performed through by electronic randomization.The interventions will take place during the length of stay in the hospital, totalizing a maximum of six days of intervention.
It is expected that the application of the Pilates method exercise method associated with conventional physiotherapy in patients in postoperative coronary artery bypass grafting improves functional capacity, flows and lung volumes and respiratory and peripheral muscle strength.
Read the detailed description
The exercise program will be held during the period of hospitalization for six days, often two to three sessions per day, totaling 12 sessions. The intervention will start on the first day postoperatively. The program may not exceed 30% of maximum heart rate reserve of the patient that will be calculated by the Karvonen formula (Karvonen, Kentala et al., 1957). The exercises will be conducted at the patient's bedside, using light resistance springs representing the lowest possible burden of springs to be used in the Pilates method. The exercises will be performed on the upper limbs alternating between the left and right upper limb and likewise would run with the lower limbs by means of a protocol consists of four exercises until the limit of resistance of the patient or interrupt pre-established criteria.
One set of each exercise with a range of up to two minutes between exercises will be held. In the first three days of intervention 10 repetitions of each exercise and the remaining three days a total of 15 repetitions of each movement will be performed.
- Conditions
- Cardiovascular Diseases
- Being tested
- Pilates, Conventional Physiotherapy
- Keywords
- Cardiovascular Diseases, Thoracic Surgery, Exercise Therapy
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
The exercise program will be held during the period of hospitalization for six days, often two to three sessions per day, totaling 12 sessions.
Conventional PhysiotherapyOther
The conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy, twice daily, six days.
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Experimental | Regarding upper limb exercises the limit of flexion and abduction less than 90°, with the exercises involving only the movement of flexion and extension of elbow shoulder will be respected. Along with patient data will be an exercise protocol based on the Pilates method that will be performed by a trained team of physiotherapists. Before and after the exercises the data of heart rate, blood pressure, oxygen saturation and subjective feeling of perceived exertion using the Modified Borg scale will be listed. Receives: Other: Pilates |
| Convencional Physiotherapy | Active comparator | The conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of functional capacity
Measured: six days
Secondary outcomes (3)
Evaluation of respiratory muscle strength
Measured: six days
Evaluation of respiratory volumes and flows
Measured: six days
Evaluation of peripheral muscle strength
Measured: six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul
- Responsible party
- Principal investigator, Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre
- Investigators
- Manoela H dos Reis, Graduated, Study chair, Federal University of Health Science of Porto AlegreLeonardo F Neves, Graduated, Study chair, University of the Sinos ValleyCinara Stein, Master, Study chair, Federal University of Health Science of Porto AlegreMirelle Hugo, Undergrad, Study chair, Federal University of Health Science of Porto AlegreAline Miozzo, Graduated, Study chair, Universidade Federal de Santa MariaChristian Coronel, Master, Study chair, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109055
- Sponsor's protocol ID
- PILATESCRM1
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Exercises Based on the Pilates Method on the Functional Capacity in Postoperative Surgery Coronery Artery Bypass Grafting: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02109055
- Acronym / sponsor ID
- PILATESCRM1
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Thoracic Surgery, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 9 Apr 2014 (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 major cause of mortality worldwide is due to cardiovascular diseases. A way to treat these diseases is coronary artery bypass grafting, one of the most common surgical procedures in the world. The incidence of post-operative complications contributes to functional decline of the patient, reduced quality of life and post-discharge mortality. Also, cardiac surgery leads to changes in lung capacity and respiratory muscle strength, causing a decrease in the function lung. Physical therapy proves to be an effective tool to combat changes resulting from cardiac surgery, demonstrating beneficial results in the pulmonary function, functional capacity, and peripheral and respiratory muscle strength. The Pilates method has been studied as a therapeutic way to healthy subjects and various kinds of diseases, but there are no studies in the literature evaluating the effect method in patients after coronary artery bypass surgery.
The aim of this study is to investigate the effect of Pilates on functional capacity , flows and lung volumes, respiratory and peripheral muscle strength after coronary artery bypass grafting.
Randomized clinical trial in which patients will be eligible after elective coronary artery bypass surgery, randomly allocated into two groups : conventional physiotherapy group (n = 15) and Pilates method associated with conventional physiotherapy group (n = 15). The outcomes will be assessed by blinded evaluator and data randomization will be performed through by electronic randomization.The interventions will take place during the length of stay in the hospital, totalizing a maximum of six days of intervention.
It is expected that the application of the Pilates method exercise method associated with conventional physiotherapy in patients in postoperative coronary artery bypass grafting improves functional capacity, flows and lung volumes and respiratory and peripheral muscle strength.
Detailed description
The exercise program will be held during the period of hospitalization for six days, often two to three sessions per day, totaling 12 sessions. The intervention will start on the first day postoperatively. The program may not exceed 30% of maximum heart rate reserve of the patient that will be calculated by the Karvonen formula (Karvonen, Kentala et al., 1957). The exercises will be conducted at the patient's bedside, using light resistance springs representing the lowest possible burden of springs to be used in the Pilates method. The exercises will be performed on the upper limbs alternating between the left and right upper limb and likewise would run with the lower limbs by means of a protocol consists of four exercises until the limit of resistance of the patient or interrupt pre-established criteria.
One set of each exercise with a range of up to two minutes between exercises will be held. In the first three days of intervention 10 repetitions of each exercise and the remaining three days a total of 15 repetitions of each movement will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates | Experimental | Other: PilatesRegarding upper limb exercises the limit of flexion and abduction less than 90°, with the exercises involving only the movement of flexion and extension of elbow shoulder will be respected. Along with patient data will be an exercise protocol based on the Pilates method that will be performed by a trained team of physiotherapists. Before and after the exercises the data of heart rate, blood pressure, oxygen saturation and subjective feeling of perceived exertion using the Modified Borg scale will be listed. |
| Convencional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyThe conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals in postoperative coronary artery bypass grafting, extubated within 24 hours after surgery, hemodynamically stable, with no ischemic changes and/or complex arrhythmias on electrocardiogram e who have performed the first surgery and surgery alone.
Key exclusion criteria (1 listed)
- Patients with decompensated heart failure, presence of any comorbidity, such as unstable angina, associated neurological disease, moderate to severe respiratory illness prior diagnosed by the attending physician, acute respiratory dysfunction in the post - operative, active infectious disease or fever; vascular disease disabling peripheral, unstable ventricular arrhythmia; musculoskeletal disease that limits the practice of Pilates 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 |
|---|---|---|
| PilatesThe exercise program will be held during the period of hospitalization for six days, often two to three sessions per day, totaling 12 sessions. | Other | Pilates |
| Conventional PhysiotherapyThe conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy, twice daily, six days. | Other | Convencional Physiotherapy |
Primary outcome
Evaluation of functional capacity
Time frame: six days
3 secondary outcomes
Evaluation of respiratory muscle strength
Time frame: six days
Evaluation of respiratory volumes and flows
Time frame: six days
Evaluation of peripheral muscle strength
Time frame: six days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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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.
Manoela H dos Reis, Graduated study chair
Federal University of Health Science of Porto Alegre
Leonardo F Neves, Graduated study chair
University of the Sinos Valley
Cinara Stein, Master study chair
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and Conventional Physiotherapy in people with Cardiovascular Diseases, run by Federal University of Health Science of Porto Alegre 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 10 Apr 2014. 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 Rodrigo DM Plentz (+55 (051) 91794399, roplentz@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of functional capacity (time frame: six days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.