CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Concurrent trainingbehavioral
Likely dose
Not stated in record
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Search/NCT06509282
NCT06509282N/ACompleted

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.

Universidad San Sebastián·interventional·Posted Jul 19, 2024·Updated Jul 19, 2024

In Brief

A clinical study evaluating Concurrent training for Cardiovascular Syndrome, Metabolic. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJul 19, 2024
Enrollment StartDec 29, 2023
Primary CompletionMar 8, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.0 years ago

Interventions

Concurrent trainingbehavioral

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.