Personalized Concurrent Exercise for Cardiovascular Risk Control and Fitness in Adults
NCT Number: NCT06509282
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Syndrome, Metabolic
Interventions: BEHAVIORAL: Concurrent training
Sponsor: Universidad San Sebastián
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-29
Completion Date: 2024-03-08
Locations: Universidad San Sebastián, Valdivia, Región De Los Ríos, Chile

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.

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.

Primary Outcome Measures: 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.|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.
Secondary Outcome Measures: 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), 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.