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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03082443
Enrollment
116
Registered
2017-03-17
Start date
2017-04-01
Completion date
2018-01-31
Last updated
2017-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Status, Quality of Life, Stress

Keywords

Cardiac rehabilitation, psychology, nutrition, stress, quality of life

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.

Interventions

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.

Sponsors

Instituto de Cardiologia do Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for stressSix weeksFor 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 lifeSix weeksFor 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.
Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for nutritional profileSix weeksFor 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026