Effects of Tai Chi Chuan in Patients After Recent Acute Myocardial Infarction
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tai Chi Chuan exercise
stretching exercise
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Unstable angina
- Severe congestive heart failure
- Severe lung disease
- Altered response of blood pressure to stress
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
stretching exercise
Tai Chi Chuan exercise
Arm Description
patients in this group held three weekly classes of 60 minutes during 12 weeks of Tai Chi Chuan, Yang style.
patients in this group held weekly classes of two stretching for 12 weeks.
Outcomes
Primary Outcome Measures
functional capacity
cardiopulmonary exercise testing (VO2)
Secondary Outcome Measures
respiratory muscle strength
PImax e PEmax were obtained using a pressure tansducer
Ambulatory blood pressure in 24 hours
24-hour blood pressure
Full Information
NCT ID
NCT01340716
First Posted
April 20, 2011
Last Updated
March 10, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01340716
Brief Title
Effects of Tai Chi Chuan in Patients After Recent Acute Myocardial Infarction
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stretching exercise
Arm Type
Active Comparator
Arm Description
patients in this group held three weekly classes of 60 minutes during 12 weeks of Tai Chi Chuan, Yang style.
Arm Title
Tai Chi Chuan exercise
Arm Type
Experimental
Arm Description
patients in this group held weekly classes of two stretching for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Tai Chi Chuan exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
stretching exercise
Intervention Description
patients in this group held weekly classes of two stretching for 12 weeks.
Primary Outcome Measure Information:
Title
functional capacity
Description
cardiopulmonary exercise testing (VO2)
Time Frame
Change from Baseline in functional capacity at 90 days
Secondary Outcome Measure Information:
Title
respiratory muscle strength
Description
PImax e PEmax were obtained using a pressure tansducer
Time Frame
Change from Baseline in respiratory muscle strength at 90 days
Title
Ambulatory blood pressure in 24 hours
Description
24-hour blood pressure
Time Frame
Change from Baseline in blood pressure at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Unstable angina
Severe congestive heart failure
Severe lung disease
Altered response of blood pressure to stress
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosane Nery
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26027624
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Tai Chi Chuan in Patients After Recent Acute Myocardial Infarction
We'll reach out to this number within 24 hrs