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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Treatment Adherence
Study Overview
Brief 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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Concurrent training
Concurrent training group
Intervention: Concurrent training (Behavioral)
Control
Control group
Outcomes
Primary Outcomes
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.
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)
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).
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).
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)
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)
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.
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)
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 (%).
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.
Secondary Outcomes
- Gender(Pre-Intervention: Initial assessment before starting the training program.)
- Ancestry(Pre-Intervention: Initial assessment before starting the training program.)
- Age(Pre-Intervention: Initial assessment before starting the training program.)
- Height(Pre-Intervention: Initial assessment before starting the training program.)
- Education Level(Pre-Intervention: Initial assessment before starting the training program.)
- Duration in Cardiovascular Health Program(Pre-Intervention: Initial assessment before starting the training program.)
- Morbid Background(Pre-Intervention: Initial assessment before starting the training program.)
- Duration of Medication Use(Pre-Intervention: Initial assessment before starting the training program.)
- Physical Activity Level(Pre-Intervention: Initial assessment before starting the training program.)
- Medications and Dosage:(Pre-Intervention: Initial assessment before starting the training program.)
- Weight(Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.)
Investigators
Johnattan Cano Montoya
Principal Investigator
Universidad San Sebastián