Clinical trial NCT06509282: Personalized Concurrent Exercise for Cardiovascular Risk Control and Fitness in Adults
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Syndrome, Metabolic
Keywords: Exercise
Concurrent training
Cardiovascular risk
Physical Fitness
Global rate scale
Adherence
Lead sponsor: Universidad San Sebastián
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

* 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.

Eligibility criteria: Inclusion Criteria:

1. 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);
2. Body mass index between 25 and 39.9 kg/m²;
3. Enrolled in the Cardiovascular Health Program;
4. Diagnosis of hypertension with the use of 1 and/or 2 antihypertensive medications;
5. Diagnosis of Type 2 Diabetes Mellitus with the use of 1 oral hypoglycemic agent, non-insulin-dependent;
6. Diagnosis of dyslipidemia with the use of 1 lipid-lowering agent;
7. Possession of a telephone device.

Exclusion Criteria:

1. Bone disease;
2. Ischemic disease or arrhythmia;
3. Chronic respiratory disease;
4. Uncontrolled chronic diseases;
5. Inability to provide informed consent or comply with the tests and exercise protocol for any reason;
6. History of oncological disease or being under investigation for suspected neoplastic disease in any part of the body;
7. Female participants who are pregnant.

Primary outcomes:
measure: Systolic and Diastolic Blood Pressure
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Mean Arterial Pressure (MAP)
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Heart Rate
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Fasting Glucose
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Cholesterol
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Triglycerides
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Body Mass Index
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Lean Mass
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Fat Mass
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Handgrip strength
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Cardiorespiratory fitness
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: VO2 peak
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Treatment Adherence
timeFrame: Post-Intervention (Week 6): Final evaluation after 6 weeks.
measure: Global Rating Scale
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Secondary outcomes:
measure: Gender
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Age
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Ancestry
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Education Level
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Duration in Cardiovascular Health Program
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Morbid Background
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Medications and Dosage:
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Duration of Medication Use
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Physical Activity Level
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Height
timeFrame: Pre-Intervention: Initial assessment before starting the training program.
measure: Weight
timeFrame: Pre-Intervention: Initial assessment before starting the training program. Post-Intervention (Week 6): Final evaluation after 6 weeks.
Other outcomes:
Locations:
city: Valdivia
country: Chile
facility: Universidad San Sebastián
state: Región De Los Ríos
Study officials:
affiliation: Universidad San Sebastián
name: Johnattan Cano Montoya, MSc.
role: STUDY_CHAIR
affiliation: Universidad San Sebastián
name: Johnattan Cano Montoya, MSc.
role: STUDY_DIRECTOR
affiliation: Universidad San Sebastián
name: Johnattan Cano Montoya, MSc.
role: PRINCIPAL_INVESTIGATOR
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