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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
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 20, 2011
    Last Updated
    March 10, 2017
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    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

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    Effects of Tai Chi Chuan in Patients After Recent Acute Myocardial Infarction

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