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临床试验/NCT03082443
NCT03082443Unknown不适用

The Effectiveness of a Group Intervention in the Nutritional Profile, Stress and Quality of Life in Patients in Cardiopulmonary Rehabilitation: a Randomized Clinical Trial

Instituto de Cardiologia do Rio Grande do Sul0 个研究点目标入组 116 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
116
主要终点
Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for nutritional profile

研究概览

简要总结

To evaluate the effectiveness of a group intervention in the nutritional profile, in the stress and in the quality of life of patients in cardiopulmonary rehabilitation. Method: Randomized clinical trial using a semi-structured interview, sociodemographic and anthropometric data collection, with 164 participants divided into a control group and intervention group, the Food Frequency Questionnaire, the Lipp Adult Stress Symptom Inventory (ISSL) ) And the SF-12 Quality of Life Assessment Questionnaire. To verify the difference in nutritional profile, stress levels and quality of life between the groups, the chi-square test will be used for categorical variables and within each group the comparison between the moments will be through the MC Nemar test. In the quantitative variables the evaluation of the interaction between group and time will be through Variance Analysis using the design in Repeated Measures. Considering a significance level p <0.05. Expected Results: It is believed that psychological and nutritional intervention in patients participating in therapeutic groups helps them to elaborate questions regarding the difficulties of coping with the disease in the daily routine and to understand the importance of lifestyle care and healthy habits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cardiopathy patients over 18 years of age, users of the Center for Cardiopulmonary and Metabolic Rehabilitation of the Cardiology Institute who signed the Term of Free and Informed Consent

排除标准

  • Patients not able to respond to questionnaires at the time of application. Patients who do not want to continue responding to the survey.

结局指标

主要结局

Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for nutritional profile

时间窗: Six weeks

For the evaluation of the patients will be used semi-structured interview, sociodemographic and anthropometric data (weight, height, body mass index and waist circumference), with 164 participants divided into a control group and intervention group, The Food Frequency Questionnaire will be applied.

Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for stress

时间窗: Six weeks

For the evaluation of the patients will be used semi-structured interview, sociodemographic data, with 164 participants divided into a control group and intervention group, the Lipp Adult Stress Symptom Inventory (ISSL) will be applied.

Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for quality of life

时间窗: Six weeks

For the evaluation of the patients will be used semi-structured interview, sociodemographic data, with 164 participants divided into a control group and intervention group,the SF-12 Quality of Life Assessment Questionnaire will be applied.

次要结局

未报告次要终点

研究者

发起方
Instituto de Cardiologia do Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giana Freitas

Nutritionist

Instituto de Cardiologia do Rio Grande do Sul

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