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

NCT ID: NCT03082443

Last Updated: 2017-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-01-31

Brief Summary

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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

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Conditions

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Stress Quality of Life Nutritional Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapeutic group

Group Type EXPERIMENTAL

Therapeutic group

Intervention Type OTHER

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Giana Freitas

Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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5287/16

Identifier Type: -

Identifier Source: org_study_id

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