← Back to all trials
Enrolling By Invitation
NCT05680025
Effect of a Physical Exercise Intervention Based on the Transtheoretical Model on Blood Pressure
Conditions: Hypertension
Sex: All
Ages: 40 Years – 70 Years
Phase: NA
Enrollment: 442
Sponsor: Coordinación de Investigación en Salud, Mexico
Location: Mexico
Summary
Background: Hypertension is a public health problem; the World Health Organization (WHO) estimates that more than 1280 million people suffer it.
The treatment of said condition is pharmacological and non-pharmacological.
Physical activity is part of the treatment, but unfortunately few adults can be classified as physically active.
There is evidence that performing physical exercise reduces systolic blood pressure by up to 5 mm Hg, which has associated with reduced heart disease by up to 9%, ictus up to 14% and all-cause mortality by 4%.
Lifestyle changing interventions, among them promoting exercise marked by a theory of behavior change, have shown positive results.
Objective: To evaluate the effect of an intervention promoting the performance of physical exercise, with specific recommendations, based on the Transtheoretical Model, on systolic blood pressure and on the amount of exercise performed (minutes/week) in patients with hypertension aged 40 to 70 years, users of primary care in the Mexican Institute for Social Security (IMSS) in Aguascalientes.
Material and methods: Randomized clinical trial, in which 442 patients with hypertension will participate.
The control group will receive conventional care and recommendations for physical exercise and diet.
The intervention group, in addition, will attend 6 workshops, one a month, which will promote performing physical exercise, with access given to videos of physical exercise routines, designed to gradually increase the exercise performed.
At the start and end of the study, blood pressure, anthropometric measurements will be taken, through a questionnaire asking about sociodemographic data, performance of physical exercise, psychosocial factors regarding physical exercise, diet and adherence to pharmacological treatment.
The characteristics of the study population by group will be described, and changes between baseline and final measurements compared, intra and intergroup, in the systolic blood pressure and minutes/week of physical exercise.
Eligibility Criteria
Inclusion Criteria:Patients with hypertension.Patients from 40 to 70 years old.IMSS primary care users at UMF No. 1, in Aguascalientes.Patients who agree to participate in the study.Exclusion Criteria:Patients with hypertension that have a medical contraindication for performing physical exercise, or whose health status suggests an individualized, supervised exercise plan (angina, arrhythmia, chronic kidney disease, lupus erythematosus).Patients who have some mental alteration that impedes answering the questionnaires or adequately following the established strategy.
Source: ClinicalTrials.gov (NCT05680025). StuddyBuddy aggregates publicly available trial information.