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ENROLLING BY INVITATION
NCT05680025
NA

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

Sponsor: Coordinación de Investigación en Salud, Mexico

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

442

Start Date

2022-08-08

Completion Date

2024-08-30

Last Updated

2024-05-29

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Physical exercise intervention

The intervention group will have access to training videos through social networks (WhatsApp and YouTube) and infographics. The mobile phone of each of the participants will allow send dates of workshops, link for videos, messages reminding to perform exercise routines. The training plan will be designed so the participants will achieve being physically active at the end of 6 months of intervention. Training will be planned to gradually, through 3 levels, increase the duration and intensity of exercises; they will have an important component of aerobic exercises and others for muscular strength. Each level of training will last two months; at each level the participants will be given 4 specific trainings and will be asked to perform two per week at level 1 and 2; and at the 3 level, 3 trainings per week. The strategy for promoting physical exercise is based on the social cognitive theory, in which the bases of the transtheoretical model are found.

BEHAVIORAL

Workshops

Six workshops to promote the performance of physical activity. The workshops will be held with groups of 15 participants. During them, the work will be to promote motivation to perform physical exercise, sharing information about the health benefits, benefits for control of the disease, together creating planning of measurable, realistic goals; reinforcing behavior when the desired advances are made, monitoring progress (using a monthly self-report of exercise performed). The participants will be motivated and congratulated each time for goals reached, self-sufficiency will be reinforced as well as greater evaluation of the advantages of performing exercise against the barriers or negative aspects perceived by the participants. These activities will be performed according to the level of exercise performed by the individuals (stage of change).

Locations (1)

Unidad de Medicina Familiar No. 1

Aguascalientes, Mexico