Effects of Laugh Therapy Associated to Cardiopulmonary Rehab

August 17, 2018 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
        • Principal Investigator:
          • Ricardo Stein, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life Questionnaire
Time Frame: 48 months
SF-36 Questionnaire of life quality
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Ricardo Stein, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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