StressNCT03082443
Group Intervention in the Nutritional Profile, Stress and Quality of Life in Patients in Cardiopulmonary Rehabilitation
A study testing Therapeutic group in people with Stress and Quality of Life, run by Instituto de Cardiologia do Rio Grande do Sul.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Quality of Life, Nutritional Status
- What is being tested?
- Therapeutic group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2017to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients not able to respond to questionnaires at the time of application. Patients who do not want to continue responding to the survey.
About this study
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
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.
- Conditions
- Stress, Quality of Life, Nutritional Status
- Being tested
- Therapeutic group
- Keywords
- Cardiac rehabilitation, psychology, nutrition, stress, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic group | Experimental | Not described Receives: Other: Therapeutic group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six weeks
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.
Measured: Six weeks
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.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Apr 2017 (estimated)
- Primary completionJun 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giana Freitas, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082443
- Sponsor's protocol ID
- 5287/16
- Status last verified
- Mar 2017
- First submitted
- 16 Feb 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03082443
- Acronym / sponsor ID
- 5287/16
- Conditions
- Stress, Quality of Life, Nutritional Status
- Keywords
- Cardiac rehabilitation, psychology, nutrition, stress, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic group | Experimental | Other: Therapeutic group |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients not able to respond to questionnaires at the time of application. Patients who do not want to continue responding to the survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic groupThe 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. | Other | Therapeutic group |
Primary outcome
Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for stress
Time frame: 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
Time frame: 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.
Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for nutritional profile
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic group in people with Stress and Quality of Life, run by Instituto de Cardiologia do Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants in a therapeutic group of patients in cardiac rehabilitation evaluated for stress (time frame: Six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.