Effects of Laugh Therapy Associated to Cardiopulmonary and Metabolic Rehabilitation in Ischemic Heart Disease: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Cardiopulmonary exercise test
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Comedy
patients in this group will watch a comedy film that will not exceed 30 minutes
干预措施: Comedy (Other)
Documentary
patients in this group will watch a documentary film that will not exceed 30 minutes.
干预措施: Documentary (Other)
结局指标
主要结局
Cardiopulmonary exercise test
时间窗: 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).
次要结局
- Quality of life Questionnaire(48 months)