Clinical trial NCT05680025: Effect of a Physical Exercise Intervention Based on the Transtheoretical Model on Blood Pressure
Official title: Effect of a Physical Exercise Intervention Based on the Transtheoretical Model, on Blood Pressure in Patients With Hypertension, Insured by Mexican Institute of Social Security, in the State of Aguascalientes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertension
Keywords: Physical exercise
Transtheoretical Model
Lifestyle
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2023-01-11
Enrollment: 442
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Change in systolic blood pressure
timeFrame: At baseline and at the end of the intervention (6 months)
Secondary outcomes:
measure: Minutes of physical exercise per week
timeFrame: At baseline and at the end of the intervention (6 months)
Other outcomes:
Locations:
city: Aguascalientes
country: Mexico
facility: Unidad de Medicina Familiar No. 1
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Ximena Duque, DS
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Mexicano del Seguro Social
name: Segundo Moran, DM
role: STUDY_CHAIR
affiliation: Instituto del Saber Montfort
name: Laura Torres
role: STUDY_CHAIR
References: