Clinical Trials in Degenerative Diseases

RESEARCH ARTICLE
Year
: 2019  |  Volume : 4  |  Issue : 2  |  Page : 43--48

Hemodynamic responses of patients with stable coronary artery disease to a comedy film: study protocol for a randomized controlled trial


Rosane Maria Nery1, Raquel Petry Buhler1, Débora Santos Macedo2, Juliana Maia Delfino2, Filipe Ferrari2, Anderson Donelli Silveira3, Marco Aurélio Lumertz Saffi1, Ricardo Stein3 
1 Exercise Cardiology Research Group (CardioEX), Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rehabilitation Division; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
2 Exercise Cardiology Research Group (CardioEX), Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rehabilitation Division; Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
3 Exercise Cardiology Research Group (CardioEX), Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rehabilitation Division; Hospital de Clínicas de Porto Alegre; Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil

Correspondence Address:
Ricardo Stein
Exercise Cardiology Research Group (CardioEX), Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rehabilitation Division; Hospital de Clínicas de Porto Alegre; Universidade Federal do Rio Grande do Sul, Porto Alegre
Brazil

Background and objective: Alternative and complementary interventions have been developed in an attempt to improve treatment and increase the survival of patients with coronary artery disease (CAD); one such intervention is laughter therapy. However, there is very little information on the effect of this therapeutic modality in patients with CAD. The present randomized controlled trial will compare the effect of 24 sessions of a comedy film and neutral documentary in patients with CAD. Subjects and methods: This is a randomized, parallel-design, examiner-blinded and controlled clinical trial. Patients with stable CAD of both sexes, aged ≥ 18 years, receiving regular follow-up at a public university hospital in Southern Brazil will be included in the trial. Subjects will be randomly allocated to an intervention group (will watch a 30-minute comedy film) or a control group (will watch a 30-minute neutral documentary). Patient recruitment will end in December 2019. Analysis of the primary outcome measure will be completed in December 2019. The current protocol version is 1.0. The study protocol was approved by the Institutional Review Board of Hospital de Clínicas de Porto Alegre (protocol No. 13-0124) on July 9, 2013. Outcome measures: The primary outcomes are the difference from baseline to the 2-month time point (corresponding to 24 sessions) in endothelial function, as assessed by brachial artery flow-mediated dilation measurement and peak oxygen consumption (peak VO2) on cardiopulmonary exercise testing. Secondary outcome measures include concentrations of inflammatory markers in blood, biochemical parameters, and quality of life. Discussion: This study will provide new evidence on the effect of an easy-to-use, inexpensive, readily deployable non pharmacological therapeutic intervention for patients with stable CAD. Trial registration: ClinicalTrials.gov identifier: NCT02824120. Date of registration: July 6, 2016.


How to cite this article:
Nery RM, Buhler RP, Macedo DS, Delfino JM, Ferrari F, Silveira AD, Lumertz Saffi MA, Stein R. Hemodynamic responses of patients with stable coronary artery disease to a comedy film: study protocol for a randomized controlled trial.Clin Trials Degener Dis 2019;4:43-48


How to cite this URL:
Nery RM, Buhler RP, Macedo DS, Delfino JM, Ferrari F, Silveira AD, Lumertz Saffi MA, Stein R. Hemodynamic responses of patients with stable coronary artery disease to a comedy film: study protocol for a randomized controlled trial. Clin Trials Degener Dis [serial online] 2019 [cited 2019 Aug 24 ];4:43-48
Available from: http://www.clinicaltdd.com/article.asp?issn=2542-3975;year=2019;volume=4;issue=2;spage=43;epage=48;aulast=Nery;type=0