Cardiac RehabilitationNCT06127537
Study on the Efficacy of HE and Therapeutic Group Factors on CR and QoL
A study testing Therapeutic Intervention Group in people with Cardiac Rehabilitation, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
This randomised study evaluates the efficacy of health education and therapeutic group factors on cardiac rehabilitation and quality of life in coronary patients attending cardiac rehabilitation programmes in Extremadura. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Therapeutic Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 16 Jun 2024
- 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
- Diagnosis of coronary heart disease, referred to the "Cardiac Prevention and Rehabilitation Unit".
Who cannot join
- Patients with disabling psychiatric disorders.
- Existence of pacemaker or automatic defibrillator.
- Presence of pregnancy or breastfeeding.
- Presence of medical conditions related to oncological conditions requiring chronic treatment with drugs or other substances.
- Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Servicio Extremeño de Salud
Badajoz, 06006
Francisco J Rodríguez Velasco, PhD, +34 924289839 ext. 89839, fcorodriguezv@unex.es
María Yuste Domínguez, MD, +34 924218100 ext. 49514, maria.yusted@salud-juntaex.es
About this study
Official title: Study on the Efficacy of Health Education and Therapeutic Group Factors on Cardiac Rehabilitation and Quality of Life in Coronary Patients
This randomised study evaluates the efficacy of health education and therapeutic group factors on cardiac rehabilitation and quality of life in coronary patients attending cardiac rehabilitation programmes in Extremadura.
Read the detailed description
Cardiac rehabilitation has been shown to be effective in improving the quality of life of patients who have suffered a cardiovascular event, as well as in preventing future cardiovascular events, demonstrating an increase in survival of between 20% and 30%, with a Class IA recommendation. Due to the prevalence of cardiovascular disease, both nationally and globally, it is important to study the benefits of these cardiac rehabilitation programmes in order to encourage their use. However, several studies have shown that for the programme to be effective, 5% to 10% weight loss must be achieved in patients, adequate nutritional education must be implemented, and behavioural and psychological intervention programmes must be incorporated in order to have an impact on adherence, psychological well-being, and coping with exercise intolerance. This project aims to study the effectiveness of health education and therapeutic group factors in cardiac rehabilitation and on quality of life in coronary patients in Cardiac Rehabilitation Units in Extremadura, including in the analysis anthropometric and body composition, nutritional, cognitive, emotional and lifestyle factors, which could act as mediators of cardiac function, reactivity to neuro-cardiovascular stress, anxiety, depression, anger-hostility, rehospitalisation, adherence, and adherence to treatment.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Therapeutic Intervention Group
- Keywords
- Quality of Life, Cardiovascular Disease, Health Education
- Medical subject headings
- Cardiovascular Diseases, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Intervention GroupBehavioural
The therapeutic group factors that are worked on in the group session with a psychologist are:
- Altruism.
- Cohesion: feeling of belonging and acceptance in a group.
- Universality: identification with the feelings, ideas or problems of the other group members.
- Interpersonal-internalisation learning: the patient understands himself/herself by sharing his/her experience with the group.
- Interpersonal-externalisation learning: the group offers the patient the possibility to express his own experience and to change his attitudes towards others.
- Counselling.
- Identification: assumption of behavioural patterns of other members as one's own.
- Reactualisation of the family experience.
- Understanding of one's own internal motivations.
- Reciprocal stimulation: the improvement of other members encourages them to solve or approach their problems in a more favourable way.
- Existential factors: empowerment of the individual.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Health Education Programme in cardiac rehabilitation without a Therapeutic Intervention Group |
| Experimental Group | Experimental | Health Education Programme in cardiac rehabilitation with a Therapeutic Intervention Group Receives: Behavioral: Therapeutic Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in basal cardiac function and stress reactivity at 8 weeks
Changes in heart rate (bpm) are monitored at rest, during treadmill or stationary bicycle exercise and in recovery (by ergometry - PEG).
Measured: 0 and 8 weeks
Changes in blood pressure over 8 weeks
Changes in blood pressure (mmHg) are monitored at rest, during exercise on a treadmill or stationary bike and in recovery. (by ergometry - PEG).
Measured: 0 and 8 weeks
Change in cardiovascular health indicators over 8 weeks
Change in the Fuster-BEWAT score (FBS): this index is derived from cardiovascular health indicators blood pressure (mmHg), physical activity (METs), body mass index (kg/m2), fruit and vegetable consumption, and smoking status; 0-1 indicates poor cardiovascular health; 2-3, intermediate; and 4-5, ideal.
Measured: 0 and 8 weeks
Changes in physical activity at 8 weeks
Changes in physical activity using the International Physical Activity Questionnaire (IPAQ): Weekly activity is recorded in Mets (Metabolic Task Equivalent or Metabolic Rate Units) per minute per week (Cat 1 - Low: <25 Mets / Cat 2 - Moderate: 25-600 Mets / Cat 3 - High: >1500 Mets).
Measured: 0 and 8 weeks
Changes in maximum prehensile strength over 8 weeks
Changes in maximal upper limb prehensile strength by dynamometry (kg).
Measured: 0 and 8 weeks
Changes in quality of life indicators over 8 weeks
Changes in the Spanish Quality of Life Questionnaire scores in post-infarction patients will be studied. The score per item ranges from 1 (never) to 5 (always). The minimum score is 40 (best health status) and the maximum 200 points (worst health status).
Measured: 0 and 8 weeks
Changes in Physical Function quality score over 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Measured: 0 and 8 weeks
Changes in Physical Role quality score over 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Measured: 0 and 8 weeks
Changes in Bodily Pain quality score over 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Measured: 0 and 8 weeks
Changes in General Health quality score over 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Measured: 0 and 8 weeks
Changes in Vitality quality score over 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Measured: 0 and 8 weeks
Changes in Social Function quality score over 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Measured: 0 and 8 weeks
Changes in Emotional Role and Mental Health quality score over 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Measured: 0 and 8 weeks
Changes in Health perception over 8 weeks
Changes in health perception will be calculated from the score of the Spanish Quality of Life Questionnaire in post-infarction patients. The score per item ranges from 1 (never) to 5 (always). The minimum score is 40 (best health status) and the maximum 200 points (worst health status).
Measured: 0 and 8 weeks
Secondary outcomes (25)
Changes in body weight composition over 8 weeks
Total patient weight are measured as a kilogram (kg).
Measured: 0 and 8 weeks
Changes in body fat mass composition over 8 weeks
Total patient body fat mass are measured as a kilogram (kg).
Measured: 0 and 8 weeks
Changes in body fat-free mass composition over 8 weeks
Total patient body fat-free mass are measured as a kilogram (kg).
Measured: 0 and 8 weeks
Changes in estimated total body water composition over 8 weeks
Total patient estimated total body water are measured as a kilogram (kg).
Measured: 0 and 8 weeks
Changes in protein composition over 8 weeks
Total patient protein are measured as a kilogram (kg).
Measured: 0 and 8 weeks
Changes in bone mineral composition over 8 weeks
Total patient bone mineral are measured as a kilogram (kg).
Measured: 0 and 8 weeks
Changes in Body Mass Index over 8 weeks
Weight (kg) and Height (m) will be combined to report BMI in kg/m^2.
Measured: 0 and 8 weeks
Changes in CUN-BAE index over 8 weeks
CUN-BAE are calculated as -44.988+(0.503×age) +(10.689 ×sex) +(3.172×BMI) -(0.026×BMI2) +(0.181×BMI×sex) -(0.02×BMI×age) -(0.005×BMI2 ×sex) +(0.00021×BMI2×age), where male=0 and female=1 for sex, measuring age in years.
Measured: 0 and 8 weeks
Changes in phase angle bioimpedance over 8 weeks
Phase angle is measured in degrees (º).
Measured: 0 and 8 weeks
Changes in the percentage of carbohydrates ingested over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of carbohydrates (%).
Measured: 0 and 8 weeks
Changes in the percentage of fat ingested over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of fat ingested (%).
Measured: 0 and 8 weeks
Changes in the percentage of protein ingested over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of protein ingested (%).
Measured: 0 and 8 weeks
Changes in the percentage of vitamins ingested over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of vitamins ingested (%).
Measured: 0 and 8 weeks
Changes in kilocalorie intake over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake shall be transformed into "Food composition tables". The value obtained will be the number of kilocalories ingested (kcal).
Measured: 0 and 8 weeks
Changes in adherence to the Mediterranean diet over 8 weeks
Changes in adherence to the Mediterranean diet. This will be studied using the Mediterranean Diet Adherence Questionnaire, which consists of 15 items with values ranging from <9 (low adherence) to >=9 (good adherence).
Measured: 0 and 8 weeks
Changes in erythrocyte parameters over 8 weeks
Erythrocyte parameters are measured as a percentage [%]
Measured: 0 and 8 weeks
Changes in glucose level over 8 weeks
Glucose is measured as a milligrams per decilitre [mg/dl]
Measured: 0 and 8 weeks
Changes in plasma albumin parameters over 8 weeks
Plasma albumin are measured as a [g/dl]
Measured: 0 and 8 weeks
Changes in total lymphocyte over 8 weeks
Total lymphocyte count are measured as a percentage [%]
Measured: 0 and 8 weeks
Changes in total triglycerides levels over 8 weeks
Total lymphocyte count are measured as a milligrams per decilitre [mg/dl]
Measured: 0 and 8 weeks
Changes in total cholesterol level over 8 weeks
Total cholesterol are measured as a milligrams per decilitre [mg/dl]
Measured: 0 and 8 weeks
Changes in high-density lipoproteins levels over 8 weeks
High-density lipoproteins are measured as a milligrams per decilitre [mg/dl]
Measured: 0 and 8 weeks
Changes in low-density lipoproteins levels over 8 weeks
Low-density lipoproteins are measured as a milligrams per decilitre [mg/dl]
Measured: 0 and 8 weeks
Changes in psychological parameters over 8 weeks
Changes in STATE-TRAIT ANXIETY scores measured by the State-Trait Anxiety Questionnaire (STAI). It consists of 40 items divided into 2 subscales: trait and state, with Likert-type responses from 0 to 3. The score can range from 0 to 60. There are no cut-off points, but the direct scores are transformed into centiles according to sex and age.
Measured: 0 and 8 weeks
Changes in adherence over 8 weeks
Change in Morisky Green Test scores. It consists of 4 items. The patient is considered to be compliant if he/she answers correctly to all 4 items. Parameter will be measured as compliant / not compliant-
Measured: 0 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Oct 2021
- Primary completion31 Jan 2024 (estimated)
- Study completion16 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund
- Responsible party
- Principal investigator, Francisco Jose Rodriguez Velasco, Universidad de Extremadura
- Investigators
- Francisco J Rodríguez Velasco, PhD, Principal investigator, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127537
- Sponsor's protocol ID
- 134/2020
- Other IDs
- IB20186, 134/2020, 19/10/2020
- Status last verified
- Nov 2023
- First submitted
- 27 Sep 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Health Education and Therapeutic Group Factors on Cardiac Rehabilitation and Quality of Life in Coronary Patients
- ClinicalTrials.gov ID
- NCT06127537
- Acronym / sponsor ID
- 134/2020
- Conditions
- Cardiac Rehabilitation
- Keywords
- Quality of Life, Cardiovascular Disease, Health Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Collaborators
- European Regional Development Fund
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 16 Jun 2024 (estimated)
- First posted
- 13 Nov 2023 (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.
This randomised study evaluates the efficacy of health education and therapeutic group factors on cardiac rehabilitation and quality of life in coronary patients attending cardiac rehabilitation programmes in Extremadura.
Detailed description
Cardiac rehabilitation has been shown to be effective in improving the quality of life of patients who have suffered a cardiovascular event, as well as in preventing future cardiovascular events, demonstrating an increase in survival of between 20% and 30%, with a Class IA recommendation. Due to the prevalence of cardiovascular disease, both nationally and globally, it is important to study the benefits of these cardiac rehabilitation programmes in order to encourage their use. However, several studies have shown that for the programme to be effective, 5% to 10% weight loss must be achieved in patients, adequate nutritional education must be implemented, and behavioural and psychological intervention programmes must be incorporated in order to have an impact on adherence, psychological well-being, and coping with exercise intolerance. This project aims to study the effectiveness of health education and therapeutic group factors in cardiac rehabilitation and on quality of life in coronary patients in Cardiac Rehabilitation Units in Extremadura, including in the analysis anthropometric and body composition, nutritional, cognitive, emotional and lifestyle factors, which could act as mediators of cardiac function, reactivity to neuro-cardiovascular stress, anxiety, depression, anger-hostility, rehospitalisation, adherence, and adherence to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Health Education Programme in cardiac rehabilitation without a Therapeutic Intervention Group |
| Experimental Group | Experimental | Behavioral: Therapeutic Intervention GroupHealth Education Programme in cardiac rehabilitation with a Therapeutic Intervention Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of coronary heart disease, referred to the "Cardiac Prevention and Rehabilitation Unit".
Key exclusion criteria (5 listed)
- Patients with disabling psychiatric disorders.
- Existence of pacemaker or automatic defibrillator.
- Presence of pregnancy or breastfeeding.
- Presence of medical conditions related to oncological conditions requiring chronic treatment with drugs or other substances.
- Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.
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 Intervention GroupThe therapeutic group factors that are worked on in the group session with a psychologist are: * Altruism. * Cohesion: feeling of belonging and acceptance in a group. * Universality: identification with the feelings, ideas or problems of the other group members. * Interpersonal-internalisation learning: the patient understands himself/herself by sharing his/her experience with the group. * Interpersonal-externalisation learning: the group offers the patient the possibility to express his own experience and to change his attitudes towards others. * Counselling. * Identification: assumption of behavioural patterns of other members as one's own. * Reactualisation of the family experience. * Understanding of one's own internal motivations. * Reciprocal stimulation: the improvement of other members encourages them to solve or approach their problems in a more favourable way. * Existential factors: empowerment of the individual. | Behavioural | Experimental Group |
Primary outcome
Changes in basal cardiac function and stress reactivity at 8 weeks
Time frame: 0 and 8 weeks
Changes in heart rate (bpm) are monitored at rest, during treadmill or stationary bicycle exercise and in recovery (by ergometry - PEG).
Changes in blood pressure over 8 weeks
Time frame: 0 and 8 weeks
Changes in blood pressure (mmHg) are monitored at rest, during exercise on a treadmill or stationary bike and in recovery. (by ergometry - PEG).
Change in cardiovascular health indicators over 8 weeks
Time frame: 0 and 8 weeks
Change in the Fuster-BEWAT score (FBS): this index is derived from cardiovascular health indicators blood pressure (mmHg), physical activity (METs), body mass index (kg/m2), fruit and vegetable consumption, and smoking status; 0-1 indicates poor cardiovascular health; 2-3, intermediate; and 4-5, ideal.
Changes in physical activity at 8 weeks
Time frame: 0 and 8 weeks
Changes in physical activity using the International Physical Activity Questionnaire (IPAQ): Weekly activity is recorded in Mets (Metabolic Task Equivalent or Metabolic Rate Units) per minute per week (Cat 1 - Low: <25 Mets / Cat 2 - Moderate: 25-600 Mets / Cat 3 - High: >1500 Mets).
Changes in maximum prehensile strength over 8 weeks
Time frame: 0 and 8 weeks
Changes in maximal upper limb prehensile strength by dynamometry (kg).
Changes in quality of life indicators over 8 weeks
Time frame: 0 and 8 weeks
Changes in the Spanish Quality of Life Questionnaire scores in post-infarction patients will be studied. The score per item ranges from 1 (never) to 5 (always). The minimum score is 40 (best health status) and the maximum 200 points (worst health status).
Changes in Physical Function quality score over 8 weeks
Time frame: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in Physical Role quality score over 8 weeks
Time frame: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in Bodily Pain quality score over 8 weeks
Time frame: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in General Health quality score over 8 weeks
Time frame: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in Vitality quality score over 8 weeks
Time frame: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in Social Function quality score over 8 weeks
Time frame: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in Emotional Role and Mental Health quality score over 8 weeks
Time frame: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in Health perception over 8 weeks
Time frame: 0 and 8 weeks
Changes in health perception will be calculated from the score of the Spanish Quality of Life Questionnaire in post-infarction patients. The score per item ranges from 1 (never) to 5 (always). The minimum score is 40 (best health status) and the maximum 200 points (worst health status).
25 secondary outcomes
Changes in body weight composition over 8 weeks
Time frame: 0 and 8 weeks
Changes in body fat mass composition over 8 weeks
Time frame: 0 and 8 weeks
Changes in body fat-free mass composition over 8 weeks
Time frame: 0 and 8 weeks
Changes in estimated total body water composition over 8 weeks
Time frame: 0 and 8 weeks
Changes in protein composition over 8 weeks
Time frame: 0 and 8 weeks
Changes in bone mineral composition over 8 weeks
Time frame: 0 and 8 weeks
Changes in Body Mass Index over 8 weeks
Time frame: 0 and 8 weeks
Changes in CUN-BAE index over 8 weeks
Time frame: 0 and 8 weeks
Changes in phase angle bioimpedance over 8 weeks
Time frame: 0 and 8 weeks
Changes in the percentage of carbohydrates ingested over 8 weeks
Time frame: 0 and 8 weeks
Changes in the percentage of fat ingested over 8 weeks
Time frame: 0 and 8 weeks
Changes in the percentage of protein ingested over 8 weeks
Time frame: 0 and 8 weeks
Changes in the percentage of vitamins ingested over 8 weeks
Time frame: 0 and 8 weeks
Changes in kilocalorie intake over 8 weeks
Time frame: 0 and 8 weeks
Changes in adherence to the Mediterranean diet over 8 weeks
Time frame: 0 and 8 weeks
Changes in erythrocyte parameters over 8 weeks
Time frame: 0 and 8 weeks
Changes in glucose level over 8 weeks
Time frame: 0 and 8 weeks
Changes in plasma albumin parameters over 8 weeks
Time frame: 0 and 8 weeks
Changes in total lymphocyte over 8 weeks
Time frame: 0 and 8 weeks
Changes in total triglycerides levels over 8 weeks
Time frame: 0 and 8 weeks
Changes in total cholesterol level over 8 weeks
Time frame: 0 and 8 weeks
Changes in high-density lipoproteins levels over 8 weeks
Time frame: 0 and 8 weeks
Changes in low-density lipoproteins levels over 8 weeks
Time frame: 0 and 8 weeks
Changes in psychological parameters over 8 weeks
Time frame: 0 and 8 weeks
Changes in adherence over 8 weeks
Time frame: 0 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Francisco J Rodríguez Velasco, PhD principal investigator
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Intervention Group in people with Cardiac Rehabilitation, run by Universidad de Extremadura at 1 site in Spain.
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 5 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Francisco J Rodríguez Velasco, PhD (+34 924289839 ext. 89839, fcorodriguezv@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in basal cardiac function and stress reactivity at 8 weeks (time frame: 0 and 8 weeks). The study lists 14 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 13 Nov 2023.