Effects of Laugh Therapy Associated to Cardiopulmonary Rehab

Not Applicable

• Conditions: Ischemic Heart Disease
• Interventions: Other: Documentary; Other: Comedy

• Registration Number: NCT02824120
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-21
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Documentary	Documentary	patients in this group will watch a documentary film that will not exceed 30 minutes.
Comedy	Comedy	patients in this group will watch a comedy film that will not exceed 30 minutes

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary exercise test	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

Name	Time	Method
Quality of life Questionnaire	48 months	SF-36 Questionnaire of life quality

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil