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Effects of Laugh Therapy Associated to Cardiopulmonary Rehab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02824120
Recruitment Status : Unknown
Verified July 2018 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : July 6, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
Laugh is more than visual and vocal behave, is always followed by a series of physiological changes, including contractions of musculoskeletal system, increase of cardiac frequency by catecholamine release and hyperventilation that promoves the increase of maximum breathing and oxygen saturation. Laugh therapy may be an alternative therapy, simple, and improve the quality of life of individuals can influence physiological and biochemical parameters of the human body.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Other: Comedy Other: Documentary Not Applicable

Detailed Description:
Methods: Randomized clinical trial with patients from outpatient ischemic heart disease of the Hospital de Clínicas de Porto Alegre , patients of both sexes in all regular monitoring. All patients will perform 30 minutes of stretching before film sessions. The exercises will be mild to moderate (modified Borg scale between 3 and 6).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Laugh Therapy Associated to Cardiopulmonary and Metabolic Rehabilitation in Ischemic Heart Disease: Randomized Clinical Trial
Actual Study Start Date : June 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Comedy
patients in this group will watch a comedy film that will not exceed 30 minutes
Other: Comedy
patients will watch comedy film

Experimental: Documentary
patients in this group will watch a documentary film that will not exceed 30 minutes.
Other: Documentary
patients will watch a documentary film




Primary Outcome Measures :
  1. Cardiopulmonary exercise test [ Time Frame: 48 months ]
    The maximum functional capacity is measured by a maximal cardiopulmonary exercise test with expired gas analysis,in the treadmill Inbramed® KT 10200 (Porto Alegre, Brazil).


Secondary Outcome Measures :
  1. Quality of life Questionnaire [ Time Frame: 48 months ]
    SF-36 Questionnaire of life quality



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ischemic heart disease diagnosis established by cardiac catheterization, with 50% lesion in at least one epicardial vessel (if the patient has had an acute coronary syndrome or have been revascularized, the event time is expected to exceed 6 months).
  • Both sexes
  • With availability to come to HCPA twice a week
  • In conditions of entering into a cardiac rehabilitation program with exercise.

Exclusion Criteria:

  • Involvement in another clinical trial.
  • Presence of autoimmune disease
  • Use of oral anticoagulant
  • Valvulopathy with mechanical or biological cardiac prosthesis
  • Presence pacemaker or implantable cardioverter
  • Left bundle branch block in 12-lead ECG
  • severe lung disease
  • Major Depression or Bipolar Disorder
  • Chronic Atrial Fibrillation
  • Left ventricular dysfunction (ejection fraction <45%)
  • Active infection or cancer (other than basal cell carcinoma)
  • Chronic Renal Failure
  • Illiteracy
  • Inability to understand the consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824120


Contacts
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Contact: Rosane M. Nery, PhD 0555133597634 rosane.nery@gmail.com

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Contact: Rosane M. Nery, PhD    0555133597634    rosane.nery@gmail.com   
Principal Investigator: Ricardo Stein, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Ricardo Stein, PhD Hospital de Clínicas de Porto Alegre
Publications:
Avezum Junior Á, Feldman A, Carvalho AC, Sousa AC, Mansur Ade P, Bozza AE, Falcão Bde A, Markman Filho BM, Polanczyk CA, Gun C, Serrano Junior CV, Oliveira CC, Moreira D, Précoma DB, Magnoni D, Albuquerque DC, Romano ER, Stefanini E, Santos ES, God EM, Ribeiro EE, Brito FS, Feitosa-Filho GS, Arruda GD, Oliveira GB, Lima GG, Dohman H, Liguori IM, Costa Junior Jde R, Saraiva JF, Maia LN, Moreira LF, Santos MA, Canesin MF, Coutinho MS, Moretti AM, Ghorayeb N, Vieira NW, Dutra OP, Coelho OR, Leães PE, Rossi PR, Andrade PB, Lemos Neto PA, Pavanello R, Costa RV, Bassan R, Esporcatte R, Miranda R, Giraldez RR, Ramos RF, Martins SK, Esteves VB, Mathias Junior W; Brazilian Society of Cardiology. [V Guideline of the Brazilian Society of Cardiology on Acute Myocardial Infarction Treatment with ST Segment Elevation]. Arq Bras Cardiol. 2015 Aug;105(2 Suppl 1):1-105. doi: 10.5935/abc.20150107. Portuguese.

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02824120    
Other Study ID Numbers: 13-0124
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
ischemic heart disease
laugh therapy
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases