Effects of Laugh Therapy Associated to Cardiopulmonary Rehab

Ischemic Heart Disease Clinical Trial

Official title:

Effects of Laugh Therapy Associated to Cardiopulmonary and Metabolic Rehabilitation in Ischemic Heart Disease: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02824120
• Other study ID #: 13-0124
• Status: Recruiting
• Phase: N/A
• Start date: June 2013
• Est. completion date: March 2019

Study information

• Verified date: July 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Rosane M. Nery, PhD
• Phone: 0555133597634
• Email: rosane.nery[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• Comedy
patients will watch comedy film
• Documentary
patients will watch a documentary film

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (22)

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. — View Citation

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Briffa TG, Eckermann SD, Griffiths AD, Harris PJ, Heath MR, Freedman SB, Donaldson LT, Briffa NK, Keech AC. Cost-effectiveness of rehabilitation after an acute coronary event: a randomised controlled trial. Med J Aust. 2005 Nov 7;183(9):450-5. — View Citation

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Hayashi K, Hayashi T, Iwanaga S, Kawai K, Ishii H, Shoji S, Murakami K. Laughter lowered the increase in postprandial blood glucose. Diabetes Care. 2003 May;26(5):1651-2. — View Citation

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Lu WA, Kuo CD. The effect of Tai Chi Chuan on the autonomic nervous modulation in older persons. Med Sci Sports Exerc. 2003 Dec;35(12):1972-6. — View Citation

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Miller M, Mangano C, Park Y, Goel R, Plotnick GD, Vogel RA. Impact of cinematic viewing on endothelial function. Heart. 2006 Feb;92(2):261-2. — View Citation

Nasir UM, Iwanaga S, Nabi AH, Urayama O, Hayashi K, Hayashi T, Kawai K, Sultana A, Murakami K, Suzuki F. Laughter therapy modulates the parameters of renin-angiotensin system in patients with type 2 diabetes. Int J Mol Med. 2005 Dec;16(6):1077-81. — View Citation

O'Connor GT, Buring JE, Yusuf S, Goldhaber SZ, Olmstead EM, Paffenbarger RS Jr, Hennekens CH. An overview of randomized trials of rehabilitation with exercise after myocardial infarction. Circulation. 1989 Aug;80(2):234-44. — View Citation

Piegas LS, Avezum A, Pereira JC, Neto JM, Hoepfner C, Farran JA, Ramos RF, Timerman A, Esteves JP; AFIRMAR Study Investigators. Risk factors for myocardial infarction in Brazil. Am Heart J. 2003 Aug;146(2):331-8. — View Citation

Sakuragi S, Sugiyama Y, Takeuchi K. Effects of laughing and weeping on mood and heart rate variability. J Physiol Anthropol Appl Human Sci. 2002 May;21(3):159-65. — View Citation

Schmaltz HN, Southern D, Ghali WA, Jelinski SE, Parsons GA, King KM, Maxwell CJ. Living alone, patient sex and mortality after acute myocardial infarction. J Gen Intern Med. 2007 May;22(5):572-8. — View Citation

Strean WB. Laughter prescription. Can Fam Physician. 2009 Oct;55(10):965-7. — View Citation

Sugawara J, Tarumi T, Tanaka H. Effect of mirthful laughter on vascular function. Am J Cardiol. 2010 Sep 15;106(6):856-9. doi: 10.1016/j.amjcard.2010.05.011. — View Citation

Vlachopoulos C, Xaplanteris P, Alexopoulos N, Aznaouridis K, Vasiliadou C, Baou K, Stefanadi E, Stefanadis C. Divergent effects of laughter and mental stress on arterial stiffness and central hemodynamics. Psychosom Med. 2009 May;71(4):446-53. doi: 10.1097/PSY.0b013e318198dcd4. Epub 2009 Feb 27. — View Citation

Yeh GY, Wood MJ, Lorell BH, Stevenson LW, Eisenberg DM, Wayne PM, Goldberger AL, Davis RB, Phillips RS. Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial. Am J Med. 2004 Oct 15;117(8):541-8. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary exercise test	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).	48 months
Secondary	Quality of life Questionnaire	SF-36 Questionnaire of life quality	48 months