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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03082443
• Other study ID #: 5287/16
• Status: Not yet recruiting
• Phase: N/A
• First received: February 16, 2017
• Last updated: March 12, 2017
• Start date: April 1, 2017
• Est. completion date: January 2018

Study information

• Verified date: March 2017
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: January 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nutritional Status
• Quality of Life
• Stress

Intervention

Other:
• Therapeutic group
The group will take place in six meetings lasting one hour. At the end of the intervention, a new group will be started. Issues related to illness, cardiopulmonary rehabilitation, aroused feelings and aspects of food education will be addressed, with the objective of improving nutritional profile, quality of life and reduction of stress level. During the meeting they will be constantly encouraged to express their feelings, doubts and exchanges of experiences. In the first individual care (both groups) an initial consultation will be performed when the sociodemographic and anthropometric data will be collected and the instruments will be applied: Lipp Adult Stress Inventory, SF-12 Quality of Life Assessment Questionnaire and Questionnaire Of Food Frequency. After three months, all participants will be reassessed by the psychologist and nutritionist and anthropometric data will be collected and the instruments applied again.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for stress	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.	Six weeks
Primary	Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for quality of life	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.	Six weeks
Primary	Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for nutritional profile	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.	Six weeks