Clinical trial NCT02824120: Effects of Laugh Therapy Associated to Cardiopulmonary Rehab
Official title: Effects of Laugh Therapy Associated to Cardiopulmonary and Metabolic Rehabilitation in Ischemic Heart Disease: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: ischemic heart disease
laugh therapy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Cardiopulmonary exercise test
timeFrame: 48 months
Secondary outcomes:
measure: Quality of life Questionnaire
timeFrame: 48 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Ricardo Stein, PhD
role: PRINCIPAL_INVESTIGATOR
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