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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910935
• Other study ID #: 2009-785-038
• Secondary ID: FIS/IMSS/PROT/G1
• Status: Completed
• Phase: N/A
• First received: July 5, 2013
• Last updated: June 4, 2014
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2014
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Coordinación de Investigación en Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Physical activity prescription to develop program in group.
Overall the intervention involves a medical reference in primary care (PHC) to hypertensive patients (during routine consultation) to assist the sports facilities of the same Institute, to develop a group program of physical activity which will last 24 weeks. Led by the trained staff in physical activity to patients with chronic diseases.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23	Cuernavaca	Morelos

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite measure of biochemical markers: total cholesterol, triglycerides and fasting blood glucose	Biochemical markers (total cholesterol, triglycerides and fasting blood glucose) among intervention and control groups, at the three moments of the study: basal measurement, 24 weeks (end of the intervention) and 36 weeks. The secondary 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.	24 weeks	No
Primary	Physical activity. Level of physical activity between intervention and control groups.	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%.	24 weeks	No
Secondary	Blood pressure	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.	24 weeks	No