Group Intervention in the Nutritional Profile, Stress and Quality of Life in Patients in Cardiopulmonary Rehabilitation

Not Applicable

• Conditions: Stress; Nutritional Status; Quality of Life
• Interventions: Other: Therapeutic group

• Registration Number: NCT03082443
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-16
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-12
• Last Update Submitted: 2017-03-12
• Study First Posted: 2017-03-17
• Last Update Posted: 2017-03-17
• Study Start: 2017-04-01
• Primary Completion: 2017-06
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Therapeutic group	Therapeutic group	-

Primary Outcome Measures

Name	Time	Method
Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for nutritional profile	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	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	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.