Effect of a Physical Exercise Intervention Based on the Transtheoretical Model on Blood Pressure

Coordinación de Investigación en Salud, Mexico

Status: Invitation-only

Conditions: Hypertension

Treatments: Behavioral: Workshops; Behavioral: Physical exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05680025

R-2021-101-054

Details and patient eligibility

About

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.

Enrollment: 442 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

442 participants in 2 patient groups

Control

No Intervention group

Description:

Participants in the control group will be invited to attend two workshops, where they will be given and have explained a guide to physical activity and one for diet for patients with hypertension. In addition to pharmacological treatment, this is the information given as part of conventional treatment patients with hypertension receive from health care personnel.

Physical exercise intervention

Experimental group

Description:

Promoting physical exercise. The intervention group will have access to training videos through social networks and infographics.

Treatment:

Behavioral: Physical exercise intervention

Behavioral: Workshops