Clinical trial NCT01910935: Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
Official title: Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Physical activity
Hypertension
Scheme reference
Primary care
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2013-07-30
Enrollment: 224
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effectiveness of a program to increase the physical activity of hypertensive patients using medical services and sports facilities of the Mexican Social Security Institute. The primary hypothesis to be proven is: The intervention will increase the proportion of hypertensive patients complying the physical activity minimum at week to get benefits on health in 20%, compare to patients in control group.

Detailed description: Secondary Hypothesis:

The intervention achieved a significant change in the group of hypertensive patients in the following variables:

1. Decreased levels of systolic and diastolic blood pressure, biochemical markers such as total cholesterol, triglycerides and fasting blood glucose and increased HDL cholesterol.
2. Increase muscular endurance and cardio-respiratory capacity according to the categories of risk stratification.
3. Decreased body weight, body mass index and waist circumference.

Eligibility criteria: Inclusion Criteria:

* diagnosed with high blood pressure \<5 years of evolution and / or without use of drug therapy to treat that condition;
* with low levels of physical activity (PA) or physically inactive (less than 150 minutes of PA at week, intensity moderate to vigorous);
* with availability to PA practice or considering begin to PA practice within the next six months (contemplation or preparation stages of the Transtheoretical Model).
* Without cardiovascular risk (assessed previously);
* Without physical or mobility problems that impede PA practice;
* Willingness to participate in the study, fulfill with outlined activities to develop the proposal.

Exclusion Criteria:

* high-risk patients according to the risk stratification of the American College of Sports Medicine;
* fulfill the high recommendation of physical activity (more than 300 minutes per week of moderate to vigorous intensity);

Primary outcomes:
measure: Physical activity. Level of physical activity between intervention and control groups.
timeFrame: 24 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 24 weeks
Other outcomes:
measure: Composite measure of biochemical markers: total cholesterol, triglycerides and fasting blood glucose
timeFrame: 24 weeks
Locations:
city: Cuernavaca
country: Mexico
facility: Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23
state: Morelos
Study officials:
affiliation: Instituto Mexicano del Seguro Social/Unidad de Investigación Epidemiologica y en Servicios de Salud.
name: Gallegos-Carrillo Katia, D. Sc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallegos-Carrillo K, Garcia-Pena C, Salmeron J, Salgado-de-Snyder VN, Vazquez-Cabrer G, Lobelo F. Exercise-referral scheme to promote physical activity among hypertensive patients: design of a cluster randomized trial in the Primary Health Care Units of Mexico's Social Security System. BMC Public Health. 2014 Jul 9;14:706. doi: 10.1186/1471-2458-14-706.