Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Physical activity prescription to develop program in group.

• Registration Number: NCT01910935
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-30
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-04
• Last Update Submitted: 2014-06-04
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physical activity prescription	Physical activity prescription to develop program in group.	24 weeks physical activity program. 1 hour, 3 times a week, moderate to vigorous intensity.

Primary Outcome Measures

Name	Time	Method
Physical activity. Level of physical activity between intervention and control groups.	24 weeks	The length of the intervention is 24 weeks, the control group will be followed for 24 weeks also. The outcome measure is a composite at three moments of the study. Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.; The intervention will be effective if the difference in the percent of population (complying the minimum recommended of physical activity) among control and intervention groups is at least of 20%.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	24 weeks	Blood pressure among intervention and control groups, at the three moments of the study: basal measurement, 24 weeks (end of the intervention) and 36 weeks. The outcome measure is a composite at three moments of the study. Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.

Trial Locations

Locations (1)

Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23; 🇲🇽 Cuernavaca, Morelos, Mexico