Personalized Concurrent Exercise for Cardiovascular Risk Control and Fitness in Adults

NCT06509282 | Completed

• 1 other identifier: 5352023
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Syndrome, Metabolic

Keywords

Exercise; Concurrent training; Cardiovascular risk; Physical Fitness; Global rate scale; Adherence

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (11)

• Gender

  Pre-Intervention: Initial assessment before starting the training program.

• Age

  Pre-Intervention: Initial assessment before starting the training program.

• Ancestry

  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.

Study Arms (2)

Concurrent training

EXPERIMENTAL

Concurrent training group

Behavioral: Concurrent training

Control

NO INTERVENTION

Control group

Interventions

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.

Concurrent training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad San Sebastián: lead

Study Sites (1)

Universidad San Sebastián

Valdivia, Los Ríos Region, Chile

Location

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MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: July 19, 2024
• Study Start: December 29, 2023
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

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CL (1)