Cardiovascular Syndrome, MetabolicNCT06509282
Personalized Concurrent Exercise for Cardiovascular Risk Control and Fitness in Adults
A study testing Concurrent training in people with Cardiovascular Syndrome, Metabolic, run by Universidad San Sebastián at 1 site in Chile.
Trial summary
Aim: To determine the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity in adults enrolled in a Cardiovascular Health Program. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Syndrome, Metabolic
- What is being tested?
- Concurrent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChile
- Study dates
- 29 Dec 2023to 8 Mar 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being physically inactive (not engaging in 300 or 150 minutes of moderate or vigorous intensity physical activity per week, respectively, as measured by the IPAQ questionnaire);
- Body mass index between 25 and 39.9 kg/m²;
- Enrolled in the Cardiovascular Health Program;
- Diagnosis of hypertension with the use of 1 and/or 2 antihypertensive medications;
- Diagnosis of Type 2 Diabetes Mellitus with the use of 1 oral hypoglycemic agent, non-insulin-dependent;
- Diagnosis of dyslipidemia with the use of 1 lipid-lowering agent;
- Possession of a telephone device.
Who cannot join
- Bone disease;
- Ischemic disease or arrhythmia;
- Chronic respiratory disease;
- Uncontrolled chronic diseases;
- Inability to provide informed consent or comply with the tests and exercise protocol for any reason;
- History of oncological disease or being under investigation for suspected neoplastic disease in any part of the body;
- Female participants who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Personalized Concurrent Exercise Prescription Guide for Controlling Cardiovascular Risk and Enhancing Physical Fitness in Adults From a Cardiovascular Health Program: A Pilot Randomized Controlled Clinical Trial.
Aim: To determine the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity in adults enrolled in a Cardiovascular Health Program.
Research Design: This pilot randomized controlled clinical trial (RCT) evaluates the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment versus pharmacological treatment alone. Outcomes: blood pressure, fasting glucose, total cholesterol, and triglycerides, muscle strength, cardiorespiratory capacity, body composition, adherence to the exercise guide, and patient perception of intervention effects, sociodemographic and medical background, physical activity level, Population: Adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia will be recruited during regular check-up hours. Detailed study information will be provided, and informed consent obtained.
Read more
Sample Size: The sample size is 15 subjects per group, accounting for a 30% dropout rate, resulting in 39 participants. Participants will be randomly assigned to experimental (EG) or control groups (CG) with a 1:1 allocation ratio. Allocation concealment will be ensured with opaque, sealed envelopes.
Evaluations: Pre- and post-intervention evaluations will be conducted in both groups. Sociodemographic and medical background information will be collected through clinical record reviews. Blood pressure, heart rate, glucose, triglycerides, cholesterol, adherence to the exercise guide, and patient perception of intervention effects will be measured using standardized procedures by trained kinesiologists.
Read the detailed description
SCIENTIFIC COMPONENT, METHODOLOGY, ETHICS, AND PLANNING
RESEARCH QUESTION AND HYPOTHESIS Research Question What is the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment, compared to pharmacological treatment alone, in controlling cardiovascular risk factors and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024? Hypothesis H1: The efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment is greater than pharmacological treatment alone in controlling cardiovascular risk factors (CVRF) and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024. (group difference hypothesis) H0: The efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment is equal to pharmacological treatment alone in controlling CVRF and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024. (group difference hypothesis) Statistical Hypothesis
Group difference hypothesis:
- H0: μA = μB
- H1: μA > μB OBJECTIVES General Objective To determine the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment, compared to pharmacological treatment alone, in controlling cardiovascular risk factors and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024.
2.2.2 Specific Objectives
- To describe the effects of applying a personalized concurrent exercise prescription guide on cardiovascular risk factors in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia.
- To describe the effects of applying a personalized concurrent exercise prescription guide on physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia.
- To evaluate adherence to the personalized concurrent exercise guide and pharmacological treatment in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia.
- To describe the clinical significance of the interventions through the calculation of effect size and the clinical relevance perceived by the participants regarding the interventions.
2.3 METHODOLOGY AND PROCEDURES Research Design The research design corresponds to a pilot randomized controlled clinical trial (RCT) with parallel groups and superiority. This design aligns with the general objective and proposed hypothesis, aiming to evaluate the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment, compared to pharmacological treatment alone, in controlling cardiovascular risk factors and physical capacity.
The primary study variables include blood pressure, fasting glucose, total cholesterol, and triglycerides, which are standard measurements for the Cardiovascular Health Program. Secondary variables include sociodemographic and medical background, level of physical activity, muscle strength, cardiorespiratory capacity, body composition, adherence to the exercise guide, and patient perception of changes experienced due to the intervention.
Population The study population will consist of adult users of the Cardiovascular Health Program (PSCV) enrolled in the External CESFAM in Valdivia. The research team will directly invite PSCV users during their regular check-up hours. Research professionals will be properly identified as staff from Universidad San Sebastián and will provide detailed information about the research, the exercise prescription guide application, program duration, benefits, and risks. Interested participants will be asked to sign informed consent. The recruitment period will last up to 1 month, extendable by another month if necessary to obtain the required sample size.
Sample Size Calculation
The sample size calculation is based on recommendations from the literature for pilot studies and includes:
- T-test - Means: difference between two independent means,
- Type I error: 5%,
- Statistical power: 80%,
- Effect size (ES): 0.5 according to Cohen's classification. Using these parameters, the recommended total sample size is fifteen subjects per group. Assuming a 30% dropout rate, the total population will correspond to thirty-nine participants. After the eligibility process, participants will be randomly assigned to an experimental group (EG) and a control group (CG) using a 1:1 allocation ratio through an online randomization system. Allocation concealment will be maintained using opaque, sealed, and consecutively numbered envelopes.
The experimental group will receive the intervention based on the personalized exercise prescription guide plus their usual pharmacological treatment associated with the PSCV, while the control group will maintain their usual pharmacological treatment associated with the PSCV.
Information Production Techniques All evaluations will be performed pre- and post-intervention in both the experimental and control groups.
Clinical Record Review:
The PSCV's responsible physician, with prior authorization from the External CESFAM's management and approval from the Valdivia Health Service Ethics Committee, will review the participants' medical records, collecting information on sociodemographic and medical background: sex, age, education, time in the cardiovascular health program, medical history, medications, dosage, and duration of medication use. These variables will be used to characterize the study sample.
Evaluations and follow-up will be conducted by trained Kinesiologists in evaluation techniques, exercise prescription, and cardiovascular risk factors, at the University of San Sebastián Health Center in Valdivia. A professional Kinesiologist will measure the variables, blinded to the participant's intervention assignment. These evaluations will encompass Cardiovascular Variables Evaluation, Cardiovascular Risk Factor, Metabolic Variables, Health-related Physical Capacity, Adherence to Treatment, and the Global Rating of Change Scale.
2.4 ANALYSIS OF ETHICAL IMPLICATIONS Risk-Benefit Analysis This study adheres to the Declaration of Helsinki, ensuring informed consent is obtained from all participants. The intervention will be conducted in both groups, with evaluations presenting minimal risk. Users may experience post-exercise muscle fatigue, which could last up to 48 hours, mitigated through education about exercise effects. The benefits include updated knowledge about participants' health status and physical capacity, with personalized exercise shown to effectively control cardiovascular risk factors.
Confidentiality Protection The clinical record review will be conducted at the External CESFAM by the PSCV responsible, and physical evaluations will be conducted at the University of San Sebastián Health Center. Participants will be assigned unique codes to preserve anonymity, with informed consent clearly stating data will not be used for purposes other than the study. Collected information will be stored securely by the Principal Investigator for 4 years, after which it will be handed over to the CESFAM. Only the research team will have access to the results.
- Conditions
- Cardiovascular Syndrome, Metabolic
- Being tested
- Concurrent training
- Keywords
- Exercise, Concurrent training, Cardiovascular risk, Physical Fitness, Global rate scale, Adherence
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent trainingBehavioural
Protocol:
Duration: 6 weeks. Frequency: 3 times a week. Type: Concurrent. This consists of a combination of aerobic exercise and muscular resistance exercise.
Details of the type of exercise:
Aerobic exercise:
Participants will perform 5-10 intervals per session of walking or jogging at a moderate to high intensity, with a rating of 5 to 10 points on the modified Borg scale of 1-10 points. Each interval will consist of 1 minute of walking or jogging, followed by 2 minutes of inactive pause.
Muscular resistance exercise:
Participants will perform concentric and eccentric and/or isometric contractions for 1 minute at an intensity of 5-10 according to the OMNI-RES scale. The rest period will last 2 minutes, and each exercise will be repeated 3 times. Three exercises per session will be performed: squats, push-ups, and plank.
Pharmacological treatment:
Participants will be asked to maintain their lifestyle, including taking prescribed medication as usual.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent training | Experimental | Concurrent training group Receives: Behavioral: Concurrent training |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic Blood Pressure
Pressure in the arteries during and between heartbeats. (mmHg)
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Mean Arterial Pressure (MAP)
Measure of the average pressure in a person's arteries during one cardiac cycle. MAP=Diastolic Blood Pressure + 1/3 (Systolic Blood Pressure-Diastolic Blood Pressure). mmHg
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Heart Rate
Number of heartbeats per minute. (bpm)
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Fasting Glucose
Blood glucose level after a fasting period. (mg/dL)
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Cholesterol
Blood cholesterol refers to the total amount of cholesterol present in the bloodstream. (mg/dL)
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Triglycerides
Blood triglycerides are a type of fat (lipid) found in the bloodstream. (mg/dL)
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Body Mass Index
The Body Mass Index (BMI) is a metric used to assess the relationship between an individual's weight and height, thereby estimating their weight category, which can range from underweight to obesity. It is calculated by dividing a person's weight in kilograms by the square of their height in meters.
The formula is: BMI = weight (kg) / [height (m)]^2
The unit of measurement for BMI is kg/m² (kilograms per square meter).
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Lean Mass
Lean mass, also known as lean body mass, refers to the portion of the body that is not composed of fat. It includes muscles, bones, internal organs, skin, body water, and other fat-free tissues. The unit of measurement for lean mass is (%).
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Fat Mass
Fat mass refers to the total amount of fat tissue in the body. The unit of measurement for lean mass is (%).
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Handgrip strength
Handgrip Dynamometry: Measurement of handgrip strength. (kgf)
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Cardiorespiratory fitness
2-Minute Step Test (2MST): is a functional fitness assessment used to evaluate an individual's cardiorespiratory fitness. During this test, the participant is instructed to march in place for two minutes, lifting their knees to a height midway between the patella (kneecap) and the iliac crest (hip bone). The goal is to count the number of times the right knee reaches the target height within the two-minute period. The primary unit of measurement for the 2-Minute Step Test is the number of steps, specifically the number of times the right knee reaches the required height within the two-minute duration.
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
VO2 peak
Peak oxygen consumption (VO2peak) refers to the maximum amount of oxygen the body can utilize during intense exercise. It is measured in milliliters of oxygen consumed per kilogram of body weight per minute (ml/kg/min). Using the number of steps in the 2-minute walk test, VO2peak will be estimated. The equation to estimate peak oxygen consumption is: VO2 (mL⋅kg-1⋅min-1) = 13.341 + 0.138 × total steps - (0.183 × BMI).
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Treatment Adherence
In the context of this study, treatment adherence refers to the extent to which participants follow the prescribed physical exercise regimen. This variable is operationalized as the completion of at least 70% of the scheduled exercise sessions. A participant will be considered "adherent" if they complete at least 70% of the scheduled exercise sessions, according to the data obtained through the described measurement methods. This figure is calculated by dividing the number of completed sessions by the total number of scheduled sessions and multiplying the result by 100.
Measured: Post-Intervention (Week 6): Final evaluation after 6 weeks.
Global Rating Scale
The Global Rating Scale (GRS) will be applied as an instrument for evaluating the patient's perception of changes experienced in their health status, functionality, or symptoms. The methodology for implementing the GRS will involve asking patients to provide a rating of their current health status compared to an established reference point, which, in our case, will be the beginning of the study.
The GRS will be presented in two formats: Numeric: Offering a range that can vary, for example, from -7 (much worse) to +7 (much better), allowing for a gradable assessment of changes. Descriptive: Providing qualitative terms such as "much worse," "no change," or "much better," facilitating patients' expression of their perception of change in a more narrative manner.
The "unit" of measurement for the GRS is the position on the numeric scale or the descriptive term that best represents the patient's perception of change.
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Secondary outcomes (11)
Gender
Gender: Biological classification of the individual. (No unit of measure)
Measured: Pre-Intervention: Initial assessment before starting the training program.
Age
Age: Number of complete years since birth. (Years)
Measured: Pre-Intervention: Initial assessment before starting the training program.
Ancestry
Ancestry: Ethnic or racial origin of the individual. (No unit of measure)
Measured: Pre-Intervention: Initial assessment before starting the training program.
Education Level
Education Level: Highest level of education achieved. (No unit of measure)
Measured: Pre-Intervention: Initial assessment before starting the training program.
Duration in Cardiovascular Health Program
Duration in Cardiovascular Health Program: Length of participation in the program. (Months or Years)
Measured: Pre-Intervention: Initial assessment before starting the training program.
Morbid Background
Morbid Background: History of previous diseases and medical conditions. (No unit of measure)
Measured: Pre-Intervention: Initial assessment before starting the training program.
Medications and Dosage:
Medications and Dosage: Description of used medications and their dosages. (mg/day or as prescribed)
Measured: Pre-Intervention: Initial assessment before starting the training program.
Duration of Medication Use
Duration of Medication Use: Length of time medications have been used. (Months or Years)
Measured: Pre-Intervention: Initial assessment before starting the training program.
Physical Activity Level
The International Physical Activity Questionnaire (IPAQ) is a recognized instrument for assessing physical activity in adults. This survey outlines the frequency (measured in days per week) and duration (hours and minutes per day) of physical activities categorized into four intensity levels: sedentary, walking, moderate physical activity, and vigorous physical activity.
For each intensity level, the units of measurement are expressed in days per week and hours or minutes per day, with specific Metabolic Equivalent Task (METs) values assigned to each activity (Walking: 3.3 METs, Moderate Physical Activity: 4 METs, Vigorous Physical Activity: 8 METs). The responses can be converted into MET-minutes/week, enabling a quantitative and consistent comparison of total physical activity, encompassing various types and intensities.
Measured: Pre-Intervention: Initial assessment before starting the training program.
Height
Individual's height. (cm)
Measured: Pre-Intervention: Initial assessment before starting the training program.
Weight
Total body mass. (kg)
Measured: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start29 Dec 2023
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Syndrome, MetabolicStudies 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
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Sebastián
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnattan Cano Montoya, Universidad San Sebastián
- Investigators
- Johnattan Cano Montoya, MSc., Study chair, Universidad San SebastiánJohnattan Cano Montoya, MSc., Study director, Universidad San SebastiánJohnattan Cano Montoya, MSc., Principal investigator, Universidad San Sebastián
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509282
- Sponsor's protocol ID
- 5352023
- Status last verified
- Jul 2024
- First submitted
- 24 May 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yusuf S, Joseph P, Rangarajan S, Islam S, Mente A, Hystad P, Brauer M, Kutty VR, Gupta R, Wielgosz A, AlHabib KF, Dans A, Lopez-Jaramillo P, Avezum A, Lanas F, Oguz A, Kruger IM, Diaz R, Yusoff K, Mony P, Chifamba J, Yeates K, Kelishadi R, Yusufali A, Khatib R, Rahman O, Zatonska K, Iqbal R, Wei L, Bo H, Rosengren A, Kaur M, Mohan V, Lear SA, Teo KK, Leong D, O'Donnell M, McKee M, Dagenais G. Modifiable risk factors, cardiovascular disease, and mortality in 155 722 individuals from 21 high-income, middle-income, and low-income countries (PURE): a prospective cohort study. Lancet. 2020 Mar 7;395(10226):795-808. doi: 10.1016/S0140-6736(19)32008-2. Epub 2019 Sep 3.
PubMed 31492503Nazzal C, Lefian A, Alonso F. [Incidence of acute myocardial infarction in Chile between 2008 and 2016]. Rev Med Chil. 2021 Mar;149(3):323-329. doi: 10.4067/s0034-98872021000300323. Spanish.
PubMed 34479310Parra-Soto S, Petermann-Rocha F, Martinez-Sanguinetti MA, Leiva-Ordenez AM, Troncoso-Pantoja C, Ulloa N, Diaz-Martinez X, Celis-Morales C. [Cancer in Chile and worldwide: an overview of the current and future epidemiological context]. Rev Med Chil. 2020 Oct;148(10):1489-1495. doi: 10.4067/S0034-98872020001001489. Spanish.
PubMed 33844720Celis-Morales C, Salas C, Martinez MA, Leiva AM, Garrido-Mendez A, Diaz-Martinez X. [The economic burden of physical inactivity in Chile]. Rev Med Chil. 2017 Aug;145(8):1091-1092. doi: 10.4067/s0034-98872017000801091. No abstract available. Spanish.
PubMed 29189871Pratt M, Macera CA, Wang G. Higher direct medical costs associated with physical inactivity. Phys Sportsmed. 2000 Oct;28(10):63-70. doi: 10.3810/psm.2000.10.1237.
PubMed 20086598Teo KK, Rafiq T. Cardiovascular Risk Factors and Prevention: A Perspective From Developing Countries. Can J Cardiol. 2021 May;37(5):733-743. doi: 10.1016/j.cjca.2021.02.009. Epub 2021 Feb 19.
PubMed 33610690Pucci GC, Rech CR, Fermino RC, Reis RS. Association between physical activity and quality of life in adults. Rev Saude Publica. 2012 Feb;46(1):166-79. doi: 10.1590/s0034-89102012000100021. English, Portuguese.
PubMed 22249758Geidl W, Schlesinger S, Mino E, Miranda L, Pfeifer K. Dose-response relationship between physical activity and mortality in adults with noncommunicable diseases: a systematic review and meta-analysis of prospective observational studies. Int J Behav Nutr Phys Act. 2020 Aug 26;17(1):109. doi: 10.1186/s12966-020-01007-5.
PubMed 32843054DeMarco VG, Aroor AR, Sowers JR. The pathophysiology of hypertension in patients with obesity. Nat Rev Endocrinol. 2014 Jun;10(6):364-76. doi: 10.1038/nrendo.2014.44. Epub 2014 Apr 15.
PubMed 24732974Bergouignan A, Rudwill F, Simon C, Blanc S. Physical inactivity as the culprit of metabolic inflexibility: evidence from bed-rest studies. J Appl Physiol (1985). 2011 Oct;111(4):1201-10. doi: 10.1152/japplphysiol.00698.2011. Epub 2011 Aug 11.
PubMed 21836047Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
PubMed 15364185Diaz-Martinez X, Petermann F, Leiva AM, Garrido-Mendez A, Salas-Bravo C, Martinez MA, Labrana AM, Duran E, Valdivia-Moral P, Zagalaz ML, Poblete-Valderrama F, Alvarez C, Celis-Morales C. [Association of physical inactivity with obesity, diabetes, hypertension and metabolic syndrome in the chilean population]. Rev Med Chil. 2018 May;146(5):585-595. doi: 10.4067/s0034-98872018000500585. Spanish.
PubMed 30148922Lear SA, Hu W, Rangarajan S, Gasevic D, Leong D, Iqbal R, Casanova A, Swaminathan S, Anjana RM, Kumar R, Rosengren A, Wei L, Yang W, Chuangshi W, Huaxing L, Nair S, Diaz R, Swidon H, Gupta R, Mohammadifard N, Lopez-Jaramillo P, Oguz A, Zatonska K, Seron P, Avezum A, Poirier P, Teo K, Yusuf S. The effect of physical activity on mortality and cardiovascular disease in 130 000 people from 17 high-income, middle-income, and low-income countries: the PURE study. Lancet. 2017 Dec 16;390(10113):2643-2654. doi: 10.1016/S0140-6736(17)31634-3. Epub 2017 Sep 21.
PubMed 28943267Cristi-Montero C, Ramirez-Campillo R, Alvarez C, Garrido Mendez A, Martinez MA, Diaz Martinez X, Leiva AM, Salas C, Gutierrez M, Sanzana-Inzunza R, Duran E, Labrana AM, Aguilar-Farias N, Celis-Morales C. [Inverse association of cardiorespiratory fitness with cardiovascular risk factors in Chilean adults]. Rev Med Chil. 2016 Aug;144(8):980-989. doi: 10.4067/S0034-98872016000800004. Spanish.
PubMed 27905643Arija V, Villalobos F, Pedret R, Vinuesa A, Timon M, Basora T, Aguas D, Basora J; Pas-a-Pas research group. Effectiveness of a physical activity program on cardiovascular disease risk in adult primary health-care users: the "Pas-a-Pas" community intervention trial. BMC Public Health. 2017 Jun 15;17(1):576. doi: 10.1186/s12889-017-4485-3.
PubMed 28619115
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Personalized Concurrent Exercise Prescription Guide for Controlling Cardiovascular Risk and Enhancing Physical Fitness in Adults From a Cardiovascular Health Program: A Pilot Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06509282
- Acronym / sponsor ID
- 5352023
- Conditions
- Cardiovascular Syndrome, Metabolic
- Keywords
- Exercise, Concurrent training, Cardiovascular risk, Physical Fitness, Global rate scale, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universidad San SebastiánUniversity, hospital or other
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 19 Jul 2024 (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.
Aim: To determine the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity in adults enrolled in a Cardiovascular Health Program.
Research Design: This pilot randomized controlled clinical trial (RCT) evaluates the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment versus pharmacological treatment alone. Outcomes: blood pressure, fasting glucose, total cholesterol, and triglycerides, muscle strength, cardiorespiratory capacity, body composition, adherence to the exercise guide, and patient perception of intervention effects, sociodemographic and medical background, physical activity level, Population: Adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia will be recruited during regular check-up hours. Detailed study information will be provided, and informed consent obtained.
Sample Size: The sample size is 15 subjects per group, accounting for a 30% dropout rate, resulting in 39 participants. Participants will be randomly assigned to experimental (EG) or control groups (CG) with a 1:1 allocation ratio. Allocation concealment will be ensured with opaque, sealed envelopes.
Evaluations: Pre- and post-intervention evaluations will be conducted in both groups. Sociodemographic and medical background information will be collected through clinical record reviews. Blood pressure, heart rate, glucose, triglycerides, cholesterol, adherence to the exercise guide, and patient perception of intervention effects will be measured using standardized procedures by trained kinesiologists.
Detailed description
SCIENTIFIC COMPONENT, METHODOLOGY, ETHICS, AND PLANNING
RESEARCH QUESTION AND HYPOTHESIS Research Question What is the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment, compared to pharmacological treatment alone, in controlling cardiovascular risk factors and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024? Hypothesis H1: The efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment is greater than pharmacological treatment alone in controlling cardiovascular risk factors (CVRF) and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024. (group difference hypothesis) H0: The efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment is equal to pharmacological treatment alone in controlling CVRF and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024. (group difference hypothesis) Statistical Hypothesis
Group difference hypothesis:
- H0: μA = μB
- H1: μA > μB OBJECTIVES General Objective To determine the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment, compared to pharmacological treatment alone, in controlling cardiovascular risk factors and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024.
2.2.2 Specific Objectives
- To describe the effects of applying a personalized concurrent exercise prescription guide on cardiovascular risk factors in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia.
- To describe the effects of applying a personalized concurrent exercise prescription guide on physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia.
- To evaluate adherence to the personalized concurrent exercise guide and pharmacological treatment in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia.
- To describe the clinical significance of the interventions through the calculation of effect size and the clinical relevance perceived by the participants regarding the interventions.
2.3 METHODOLOGY AND PROCEDURES Research Design The research design corresponds to a pilot randomized controlled clinical trial (RCT) with parallel groups and superiority. This design aligns with the general objective and proposed hypothesis, aiming to evaluate the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment, compared to pharmacological treatment alone, in controlling cardiovascular risk factors and physical capacity.
The primary study variables include blood pressure, fasting glucose, total cholesterol, and triglycerides, which are standard measurements for the Cardiovascular Health Program. Secondary variables include sociodemographic and medical background, level of physical activity, muscle strength, cardiorespiratory capacity, body composition, adherence to the exercise guide, and patient perception of changes experienced due to the intervention.
Population The study population will consist of adult users of the Cardiovascular Health Program (PSCV) enrolled in the External CESFAM in Valdivia. The research team will directly invite PSCV users during their regular check-up hours. Research professionals will be properly identified as staff from Universidad San Sebastián and will provide detailed information about the research, the exercise prescription guide application, program duration, benefits, and risks. Interested participants will be asked to sign informed consent. The recruitment period will last up to 1 month, extendable by another month if necessary to obtain the required sample size.
Sample Size Calculation
The sample size calculation is based on recommendations from the literature for pilot studies and includes:
- T-test - Means: difference between two independent means,
- Type I error: 5%,
- Statistical power: 80%,
- Effect size (ES): 0.5 according to Cohen's classification. Using these parameters, the recommended total sample size is fifteen subjects per group. Assuming a 30% dropout rate, the total population will correspond to thirty-nine participants. After the eligibility process, participants will be randomly assigned to an experimental group (EG) and a control group (CG) using a 1:1 allocation ratio through an online randomization system. Allocation concealment will be maintained using opaque, sealed, and consecutively numbered envelopes.
The experimental group will receive the intervention based on the personalized exercise prescription guide plus their usual pharmacological treatment associated with the PSCV, while the control group will maintain their usual pharmacological treatment associated with the PSCV.
Information Production Techniques All evaluations will be performed pre- and post-intervention in both the experimental and control groups.
Clinical Record Review:
The PSCV's responsible physician, with prior authorization from the External CESFAM's management and approval from the Valdivia Health Service Ethics Committee, will review the participants' medical records, collecting information on sociodemographic and medical background: sex, age, education, time in the cardiovascular health program, medical history, medications, dosage, and duration of medication use. These variables will be used to characterize the study sample.
Evaluations and follow-up will be conducted by trained Kinesiologists in evaluation techniques, exercise prescription, and cardiovascular risk factors, at the University of San Sebastián Health Center in Valdivia. A professional Kinesiologist will measure the variables, blinded to the participant's intervention assignment. These evaluations will encompass Cardiovascular Variables Evaluation, Cardiovascular Risk Factor, Metabolic Variables, Health-related Physical Capacity, Adherence to Treatment, and the Global Rating of Change Scale.
2.4 ANALYSIS OF ETHICAL IMPLICATIONS Risk-Benefit Analysis This study adheres to the Declaration of Helsinki, ensuring informed consent is obtained from all participants. The intervention will be conducted in both groups, with evaluations presenting minimal risk. Users may experience post-exercise muscle fatigue, which could last up to 48 hours, mitigated through education about exercise effects. The benefits include updated knowledge about participants' health status and physical capacity, with personalized exercise shown to effectively control cardiovascular risk factors.
Confidentiality Protection The clinical record review will be conducted at the External CESFAM by the PSCV responsible, and physical evaluations will be conducted at the University of San Sebastián Health Center. Participants will be assigned unique codes to preserve anonymity, with informed consent clearly stating data will not be used for purposes other than the study. Collected information will be stored securely by the Principal Investigator for 4 years, after which it will be handed over to the CESFAM. Only the research team will have access to the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent training | Experimental | Behavioral: Concurrent trainingConcurrent training group |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being physically inactive (not engaging in 300 or 150 minutes of moderate or vigorous intensity physical activity per week, respectively, as measured by the IPAQ questionnaire);
- Body mass index between 25 and 39.9 kg/m²;
- Enrolled in the Cardiovascular Health Program;
- Diagnosis of hypertension with the use of 1 and/or 2 antihypertensive medications;
- Diagnosis of Type 2 Diabetes Mellitus with the use of 1 oral hypoglycemic agent, non-insulin-dependent;
Key exclusion criteria (7 listed)
- Bone disease;
- Ischemic disease or arrhythmia;
- Chronic respiratory disease;
- Uncontrolled chronic diseases;
- Inability to provide informed consent or comply with the tests and exercise protocol for any reason;
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 |
|---|---|---|
| Concurrent trainingProtocol: Duration: 6 weeks. Frequency: 3 times a week. Type: Concurrent. This consists of a combination of aerobic exercise and muscular resistance exercise. Details of the type of exercise: Aerobic exercise: Participants will perform 5-10 intervals per session of walking or jogging at a moderate to high intensity, with a rating of 5 to 10 points on the modified Borg scale of 1-10 points. Each interval will consist of 1 minute of walking or jogging, followed by 2 minutes of inactive pause. Muscular resistance exercise: Participants will perform concentric and eccentric and/or isometric contractions for 1 minute at an intensity of 5-10 according to the OMNI-RES scale. The rest period will last 2 minutes, and each exercise will be repeated 3 times. Three exercises per session will be performed: squats, push-ups, and plank. Pharmacological treatment: Participants will be asked to maintain their lifestyle, including taking prescribed medication as usual. | Behavioural | Concurrent training |
Primary outcome
Systolic and Diastolic Blood Pressure
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Pressure in the arteries during and between heartbeats. (mmHg)
Mean Arterial Pressure (MAP)
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Measure of the average pressure in a person's arteries during one cardiac cycle. MAP=Diastolic Blood Pressure + 1/3 (Systolic Blood Pressure-Diastolic Blood Pressure). mmHg
Heart Rate
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Number of heartbeats per minute. (bpm)
Fasting Glucose
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Blood glucose level after a fasting period. (mg/dL)
Cholesterol
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Blood cholesterol refers to the total amount of cholesterol present in the bloodstream. (mg/dL)
Triglycerides
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Blood triglycerides are a type of fat (lipid) found in the bloodstream. (mg/dL)
Body Mass Index
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
The Body Mass Index (BMI) is a metric used to assess the relationship between an individual's weight and height, thereby estimating their weight category, which can range from underweight to obesity. It is calculated by dividing a person's weight in kilograms by the square of their height in meters. The formula is: BMI = weight (kg) / [height (m)]^2 The unit of measurement for BMI is kg/m² (kilograms per square meter).
Lean Mass
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Lean mass, also known as lean body mass, refers to the portion of the body that is not composed of fat. It includes muscles, bones, internal organs, skin, body water, and other fat-free tissues. The unit of measurement for lean mass is (%).
Fat Mass
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Fat mass refers to the total amount of fat tissue in the body. The unit of measurement for lean mass is (%).
Handgrip strength
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Handgrip Dynamometry: Measurement of handgrip strength. (kgf)
Cardiorespiratory fitness
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
2-Minute Step Test (2MST): is a functional fitness assessment used to evaluate an individual's cardiorespiratory fitness. During this test, the participant is instructed to march in place for two minutes, lifting their knees to a height midway between the patella (kneecap) and the iliac crest (hip bone). The goal is to count the number of times the right knee reaches the target height within the two-minute period. The primary unit of measurement for the 2-Minute Step Test is the number of steps, specifically the number of times the right knee reaches the required height within the two-minute duration.
VO2 peak
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Peak oxygen consumption (VO2peak) refers to the maximum amount of oxygen the body can utilize during intense exercise. It is measured in milliliters of oxygen consumed per kilogram of body weight per minute (ml/kg/min). Using the number of steps in the 2-minute walk test, VO2peak will be estimated. The equation to estimate peak oxygen consumption is: VO2 (mL⋅kg-1⋅min-1) = 13.341 + 0.138 × total steps - (0.183 × BMI).
Treatment Adherence
Time frame: Post-Intervention (Week 6): Final evaluation after 6 weeks.
In the context of this study, treatment adherence refers to the extent to which participants follow the prescribed physical exercise regimen. This variable is operationalized as the completion of at least 70% of the scheduled exercise sessions. A participant will be considered "adherent" if they complete at least 70% of the scheduled exercise sessions, according to the data obtained through the described measurement methods. This figure is calculated by dividing the number of completed sessions by the total number of scheduled sessions and multiplying the result by 100.
Global Rating Scale
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
The Global Rating Scale (GRS) will be applied as an instrument for evaluating the patient's perception of changes experienced in their health status, functionality, or symptoms. The methodology for implementing the GRS will involve asking patients to provide a rating of their current health status compared to an established reference point, which, in our case, will be the beginning of the study. The GRS will be presented in two formats: Numeric: Offering a range that can vary, for example, from -7 (much worse) to +7 (much better), allowing for a gradable assessment of changes. Descriptive: Providing qualitative terms such as "much worse," "no change," or "much better," facilitating patients' expression of their perception of change in a more narrative manner. The "unit" of measurement for the GRS is the position on the numeric scale or the descriptive term that best represents the patient's perception of change.
11 secondary outcomes
Gender
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Age
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Ancestry
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Education Level
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Duration in Cardiovascular Health Program
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Morbid Background
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Medications and Dosage:
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Duration of Medication Use
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Physical Activity Level
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Height
Time frame: Pre-Intervention: Initial assessment before starting the training program.
Weight
Time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 31492503Yusuf S, Joseph P, Rangarajan S, Islam S, Mente A, Hystad P, Brauer M, Kutty VR, Gupta R, Wielgosz A, AlHabib KF, Dans A, Lopez-Jaramillo P, Avezum A, Lanas F, Oguz A, Kruger IM, Diaz R, Yusoff K, Mony P, Chifamba J, Yeates K, Kelishadi R, Yusufali A, Khatib R, Rahman O, Zatonska K, Iqbal R, Wei L, Bo H, Rosengren A, Kaur M, Mohan V, Lear SA, Teo KK, Leong D, O'Donnell M, McKee M, Dagenais G. Modifiable risk factors, cardiovascular disease, and mortality in 155 722 individuals from 21 high-income, middle-income, and low-income countries (PURE): a prospective cohort study. Lancet. 2020 Mar 7;395(10226):795-808. doi: 10.1016/S0140-6736(19)32008-2. Epub 2019 Sep 3.
- Background: PubMed 34479310Nazzal C, Lefian A, Alonso F. [Incidence of acute myocardial infarction in Chile between 2008 and 2016]. Rev Med Chil. 2021 Mar;149(3):323-329. doi: 10.4067/s0034-98872021000300323. Spanish.
- Background: PubMed 33844720Parra-Soto S, Petermann-Rocha F, Martinez-Sanguinetti MA, Leiva-Ordenez AM, Troncoso-Pantoja C, Ulloa N, Diaz-Martinez X, Celis-Morales C. [Cancer in Chile and worldwide: an overview of the current and future epidemiological context]. Rev Med Chil. 2020 Oct;148(10):1489-1495. doi: 10.4067/S0034-98872020001001489. Spanish.
- Background: PubMed 29189871Celis-Morales C, Salas C, Martinez MA, Leiva AM, Garrido-Mendez A, Diaz-Martinez X. [The economic burden of physical inactivity in Chile]. Rev Med Chil. 2017 Aug;145(8):1091-1092. doi: 10.4067/s0034-98872017000801091. No abstract available. Spanish.
- Background: PubMed 20086598Pratt M, Macera CA, Wang G. Higher direct medical costs associated with physical inactivity. Phys Sportsmed. 2000 Oct;28(10):63-70. doi: 10.3810/psm.2000.10.1237.
- Background: PubMed 33610690Teo KK, Rafiq T. Cardiovascular Risk Factors and Prevention: A Perspective From Developing Countries. Can J Cardiol. 2021 May;37(5):733-743. doi: 10.1016/j.cjca.2021.02.009. Epub 2021 Feb 19.
- Background: PubMed 22249758Pucci GC, Rech CR, Fermino RC, Reis RS. Association between physical activity and quality of life in adults. Rev Saude Publica. 2012 Feb;46(1):166-79. doi: 10.1590/s0034-89102012000100021. English, Portuguese.
- Background: PubMed 32843054Geidl W, Schlesinger S, Mino E, Miranda L, Pfeifer K. Dose-response relationship between physical activity and mortality in adults with noncommunicable diseases: a systematic review and meta-analysis of prospective observational studies. Int J Behav Nutr Phys Act. 2020 Aug 26;17(1):109. doi: 10.1186/s12966-020-01007-5.
- Background: PubMed 24732974DeMarco VG, Aroor AR, Sowers JR. The pathophysiology of hypertension in patients with obesity. Nat Rev Endocrinol. 2014 Jun;10(6):364-76. doi: 10.1038/nrendo.2014.44. Epub 2014 Apr 15.
- Background: PubMed 21836047Bergouignan A, Rudwill F, Simon C, Blanc S. Physical inactivity as the culprit of metabolic inflexibility: evidence from bed-rest studies. J Appl Physiol (1985). 2011 Oct;111(4):1201-10. doi: 10.1152/japplphysiol.00698.2011. Epub 2011 Aug 11.
- Background: PubMed 15364185Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
- Background: PubMed 30148922Diaz-Martinez X, Petermann F, Leiva AM, Garrido-Mendez A, Salas-Bravo C, Martinez MA, Labrana AM, Duran E, Valdivia-Moral P, Zagalaz ML, Poblete-Valderrama F, Alvarez C, Celis-Morales C. [Association of physical inactivity with obesity, diabetes, hypertension and metabolic syndrome in the chilean population]. Rev Med Chil. 2018 May;146(5):585-595. doi: 10.4067/s0034-98872018000500585. Spanish.
- 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.
Johnattan Cano Montoya, MSc. study chair
Universidad San Sebastián
Johnattan Cano Montoya, MSc. study director
Universidad San Sebastián
Johnattan Cano Montoya, MSc. principal investigator
Universidad San Sebastián
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent training in people with Cardiovascular Syndrome, Metabolic, run by Universidad San Sebastián at 1 site in Chile.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 19 Jul 2024. 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 Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Systolic and Diastolic Blood Pressure (time frame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 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?
On the ClinicalTrials.gov record for NCT06509282, which also lists 50 linked publications.
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 19 Jul 2024.