Personalized Concurrent Exercise for Cardiovascular Risk Control and Fitness in Adults

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

Interventions

BEHAVIORAL

Concurrent training

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.

Sponsors & Collaborators

• Universidad San Sebastián

  lead OTHER

Principal Investigators

• Johnattan Cano Montoya, MSc. · Universidad San Sebastián

• Johnattan Cano Montoya, MSc. · Universidad San Sebastián

• Johnattan Cano Montoya, MSc. · Universidad San Sebastián

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-29

Primary Completion

2024-03-08

Completion

2024-03-08

Countries

• Chile

Study Locations