Back to resultsEffects of Laugh Therapy Associated to Cardiopulmonary Rehab
Primary Purpose
Ischemic Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Comedy
Documentary
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring ischemic heart disease, laugh therapy
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
Sites / Locations
- Hospital de Clínicas de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Comedy
Documentary
Arm Description
patients in this group will watch a comedy film that will not exceed 30 minutes
patients in this group will watch a documentary film that will not exceed 30 minutes.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Quality of life Questionnaire
SF-36 Questionnaire of life quality
Full Information
NCT ID
NCT02824120
First Posted
February 22, 2016
Last Updated
August 17, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02824120
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
ischemic heart disease, laugh therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comedy
Arm Type
Experimental
Arm Description
patients in this group will watch a comedy film that will not exceed 30 minutes
Arm Title
Documentary
Arm Type
Experimental
Arm Description
patients in this group will watch a documentary film that will not exceed 30 minutes.
Intervention Type
Other
Intervention Name(s)
Comedy
Intervention Description
patients will watch comedy film
Intervention Type
Other
Intervention Name(s)
Documentary
Intervention Description
patients will watch a documentary film
Primary Outcome Measure Information:
Title
Cardiopulmonary exercise test
Description
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).
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Quality of life Questionnaire
Description
SF-36 Questionnaire of life quality
Time Frame
48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosane M. Nery, PhD
Phone
0555133597634
Email
rosane.nery@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Stein, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosane M. Nery, PhD
Phone
0555133597634
Email
rosane.nery@gmail.com
First Name & Middle Initial & Last Name & Degree
Ricardo Stein, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Laugh Therapy Associated to Cardiopulmonary Rehab
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