NCT05680025

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

ENROLLING BY INVITATION NA Last updated 29 May 2024

What this trial tests

NA trial testing Physical exercise intervention in Hypertension in 442 participants. Enrolling by invitation.

Timeline

8 August 2022

Primary endpoint
15 December 2023

30 August 2024

Quick facts

Lead sponsor	Coordinación de Investigación en Salud, Mexico
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	442
Start date	8 August 2022
Primary completion	15 December 2023
Estimated completion	30 August 2024
Sites	1 location across Mexico

Drugs / interventions tested

• Physical exercise intervention
• Workshops

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Coordinación de Investigación en Salud, Mexico — full company profile →

Who can join

Adults 40 to 70, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of a physical activity promotion intervention based on the transtheoretical model on blood pressure in patients with hypertension attending primary care: a randomized controlled trial.
   Padilla-López J, Torres-Duque L, Muñoz S, Prado-Aguilar CA, et al · · 2026 · PMID 41634617 · DOI 10.1186/s12875-026-03199-4