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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.
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:
2.2.2 Specific Objectives
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent training | Experimental | Concurrent training group |
|
| Control | No Intervention | Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and Diastolic Blood Pressure | Pressure in the arteries during and between heartbeats. (mmHg) | 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 | 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) | 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) | 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) | 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) | Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Gender | Gender: Biological classification of the individual. (No unit of measure) | Pre-Intervention: Initial assessment before starting the training program. |
| Age | Age: Number of complete years since birth. (Years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnattan Cano Montoya, MSc. | Universidad San Sebastián | Study Chair |
| Johnattan Cano Montoya, MSc. | Universidad San Sebastián | Study Director |
| Johnattan Cano Montoya, MSc. | Universidad San Sebastián | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad San Sebastián | Valdivia | Los RÃos Region | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31492503 | Background | 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. | |
| 34479310 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 23, 2024 | May 24, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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The concealment of allocation will be conducted by a researcher not involved in the clinical procedures of the intervention using the method of opaque, sealed, and consecutively numbered envelopes. The random sequence and allocation concealment allow for the control of selection bias.
For enhanced bias control, the data analysis will be performed by a researcher blinded to the intervention groups.
|
| 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). | 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 (%). | 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 (%). | 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) | 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. | 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). | 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. | 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. | Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks. |
| Pre-Intervention: Initial assessment before starting the training program. |
| Ancestry | Ancestry: Ethnic or racial origin of the individual. (No unit of measure) | Pre-Intervention: Initial assessment before starting the training program. |
| Education Level | Education Level: Highest level of education achieved. (No unit of measure) | 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) | Pre-Intervention: Initial assessment before starting the training program. |
| Morbid Background | Morbid Background: History of previous diseases and medical conditions. (No unit of measure) | 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) | 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) | 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. | Pre-Intervention: Initial assessment before starting the training program. |
| Height | Individual's height. (cm) | Pre-Intervention: Initial assessment before starting the training program. |
| Weight | Total body mass. (kg) | Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks. |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001519 | Behavior |