Effects of Laugh Therapy Associated to Cardiopulmonary Rehab

NCT ID: NCT02824120

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Comedy

patients in this group will watch a comedy film that will not exceed 30 minutes

Group Type EXPERIMENTAL

Comedy

Intervention Type OTHER

patients will watch comedy film

Documentary

patients in this group will watch a documentary film that will not exceed 30 minutes.

Group Type EXPERIMENTAL

Documentary

Intervention Type OTHER

patients will watch a documentary film

Interventions

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Comedy

patients will watch comedy film

Intervention Type OTHER

Documentary

patients will watch a documentary film

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Stein, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rosane M. Nery, PhD

Role: CONTACT

0555133597634

Facility Contacts

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Rosane M. Nery, PhD

Role: primary

0555133597634

References

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Reference Type BACKGROUND
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Avezum Junior A, Feldman A, Carvalho AC, Sousa AC, Mansur Ade P, Bozza AE, Falcao Bde A, Markman Filho BM, Polanczyk CA, Gun C, Serrano Junior CV, Oliveira CC, Moreira D, Precoma 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, Leaes 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. No abstract available. Portuguese.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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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.

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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.

Reference Type BACKGROUND
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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. doi: 10.2337/diacare.26.5.1651. No abstract available.

Reference Type BACKGROUND
PMID: 12716853 (View on PubMed)

Berk LS, Tan SA, Fry WF, Napier BJ, Lee JW, Hubbard RW, Lewis JE, Eby WC. Neuroendocrine and stress hormone changes during mirthful laughter. Am J Med Sci. 1989 Dec;298(6):390-6. doi: 10.1097/00000441-198912000-00006.

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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. doi: 10.2114/jpa.21.159.

Reference Type BACKGROUND
PMID: 12148458 (View on PubMed)

Other Identifiers

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13-0124

Identifier Type: -

Identifier Source: org_study_id

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