Acute Myocardial InfarctionNCT01340716
Effects of Tai Chi Chuan in Patients After Recent Acute Myocardial Infarction
A study testing Tai Chi Chuan exercise and stretching exercise in people with Acute Myocardial Infarction, run by Hospital de Clinicas de Porto Alegre.
Trial summary
This is a randomized Clinical Trial to assess the effects of Tai Chi Chuan on blood pressure, respiratory muscle strength and functional capacity in patients after recent acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Tai Chi Chuan exercise and stretching exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recent acute myocardial infarction
- Age 45 and 75 years.
- admission until 20 days after hospital discharge
- With physical conditions for a cardiac rehabilitation program with exercise.
Who cannot join
- Unstable angina
- Severe congestive heart failure
- Severe lung disease
- Altered response of blood pressure to stress
About this study
Official title: Effects of Tai Chi Chuan on Blood Pressure, Respiratory Muscle Strength and Functional Capacity in Patients After Recent Acute Myocardial Infarction: a Randomized Clinical Trial
This is a randomized Clinical Trial to assess the effects of Tai Chi Chuan on blood pressure, respiratory muscle strength and functional capacity in patients after recent acute myocardial infarction.
Read the detailed description
Background:Patients with a recent myocardial infarction (MI) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption (VO2 peak). The impact of a Tai Chi Chuan (TCC) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI.
Methods: A single-blind randomized clinical trial was conducted. The researchers who performed the tests were blinded to group allocation. Between the 14th and 21st days after hospital discharge, all patients performed a cardiopulmonary exercise testing and a laboratory blood workup. Mean age was similar (56 ± 9 years in the TCC group and 60 ± 9 years in the control group). Patients allocated to the intervention group performed 3 weekly sessions of TCC Beijin style for 12 weeks (n = 31). The control group participated in 3 weekly sessions of full-body stretching exercises (n = 30).
- Conditions
- Acute Myocardial Infarction
- Being tested
- Tai Chi Chuan exercise, stretching exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi Chuan exerciseOther
patients in this group held three weekly classes of 60 minutes during 12 weeks of Tai Chi Chuan, Yang style. The exercises will be mild to moderate (HR 60 to 75% of HR Max). Slow movements combined with exercises and maintained using your own body weight.
stretching exerciseOther
patients in this group held weekly classes of two stretching for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| stretching exercise | Active comparator | patients in this group held three weekly classes of 60 minutes during 12 weeks of Tai Chi Chuan, Yang style. Receives: Other: stretching exercise |
| Tai Chi Chuan exercise | Experimental | patients in this group held weekly classes of two stretching for 12 weeks. Receives: Other: Tai Chi Chuan exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional capacity
cardiopulmonary exercise testing (VO2)
Measured: Change from Baseline in functional capacity at 90 days
Secondary outcomes (2)
respiratory muscle strength
PImax e PEmax were obtained using a pressure tansducer
Measured: Change from Baseline in respiratory muscle strength at 90 days
Ambulatory blood pressure in 24 hours
24-hour blood pressure
Measured: Change from Baseline in blood pressure at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosane Nery, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340716
- Sponsor's protocol ID
- GPPG 100531
- Status last verified
- Feb 2016
- First submitted
- 20 Apr 2011
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Nery RM, Zanini M, de Lima JB, Buhler RP, da Silveira AD, Stein R. Tai Chi Chuan improves functional capacity after myocardial infarction: A randomized clinical trial. Am Heart J. 2015 Jun;169(6):854-60. doi: 10.1016/j.ahj.2015.01.017. Epub 2015 Mar 13.
PubMed 26027624
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tai Chi Chuan on Blood Pressure, Respiratory Muscle Strength and Functional Capacity in Patients After Recent Acute Myocardial Infarction: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01340716
- Acronym / sponsor ID
- GPPG 100531
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized Clinical Trial to assess the effects of Tai Chi Chuan on blood pressure, respiratory muscle strength and functional capacity in patients after recent acute myocardial infarction.
Detailed description
Background:Patients with a recent myocardial infarction (MI) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption (VO2 peak). The impact of a Tai Chi Chuan (TCC) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI.
Methods: A single-blind randomized clinical trial was conducted. The researchers who performed the tests were blinded to group allocation. Between the 14th and 21st days after hospital discharge, all patients performed a cardiopulmonary exercise testing and a laboratory blood workup. Mean age was similar (56 ± 9 years in the TCC group and 60 ± 9 years in the control group). Patients allocated to the intervention group performed 3 weekly sessions of TCC Beijin style for 12 weeks (n = 31). The control group participated in 3 weekly sessions of full-body stretching exercises (n = 30).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stretching exercise | Active comparator | Other: stretching exercisepatients in this group held three weekly classes of 60 minutes during 12 weeks of Tai Chi Chuan, Yang style. |
| Tai Chi Chuan exercise | Experimental | Other: Tai Chi Chuan exercisepatients in this group held weekly classes of two stretching for 12 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent acute myocardial infarction
- Age 45 and 75 years.
- admission until 20 days after hospital discharge
- With physical conditions for a cardiac rehabilitation program with exercise.
Key exclusion criteria (4 listed)
- Unstable angina
- Severe congestive heart failure
- Severe lung disease
- Altered response of blood pressure to stress
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 |
|---|---|---|
| Tai Chi Chuan exercisepatients in this group held three weekly classes of 60 minutes during 12 weeks of Tai Chi Chuan, Yang style. The exercises will be mild to moderate (HR 60 to 75% of HR Max). Slow movements combined with exercises and maintained using your own body weight. | Other | Tai Chi Chuan exercise |
| stretching exercisepatients in this group held weekly classes of two stretching for 12 weeks. | Other | stretching exercise |
Primary outcome
functional capacity
Time frame: Change from Baseline in functional capacity at 90 days
cardiopulmonary exercise testing (VO2)
2 secondary outcomes
respiratory muscle strength
Time frame: Change from Baseline in respiratory muscle strength at 90 days
Ambulatory blood pressure in 24 hours
Time frame: Change from Baseline in blood pressure at 90 days
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 14 Mar 2017.
- Derived from this study: PubMed 26027624Nery RM, Zanini M, de Lima JB, Buhler RP, da Silveira AD, Stein R. Tai Chi Chuan improves functional capacity after myocardial infarction: A randomized clinical trial. Am Heart J. 2015 Jun;169(6):854-60. doi: 10.1016/j.ahj.2015.01.017. Epub 2015 Mar 13.
- Individual participant dataSharing planned: Undecided
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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.
Rosane Nery principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Chuan exercise and stretching exercise in people with Acute Myocardial Infarction, run by Hospital de Clinicas de Porto Alegre.
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 4 inclusion and 4 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
functional capacity (time frame: Change from Baseline in functional capacity at 90 days). 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 NCT01340716, which also lists 1 linked publication.
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 14 Mar 2017.