Back to resultsEffectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Physical activity prescription to develop program in group.
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension focused on measuring Physical activity, Hypertension, Scheme reference, Primary care
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);
Sites / Locations
- Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physical activity prescription
No physical activity prescription
Arm Description
24 weeks physical activity program. 1 hour, 3 times a week, moderate to vigorous intensity.
Provide information to patients about the benefits of physical activity and how to increase it safely.
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01910935
First Posted
July 5, 2013
Last Updated
June 4, 2014
Sponsor
Coordinación de Investigación en Salud, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT01910935
Brief Title
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
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Decreased levels of systolic and diastolic blood pressure, biochemical markers such as total cholesterol, triglycerides and fasting blood glucose and increased HDL cholesterol.
Increase muscular endurance and cardio-respiratory capacity according to the categories of risk stratification.
Decreased body weight, body mass index and waist circumference.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Physical activity, Hypertension, Scheme reference, Primary care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical activity prescription
Arm Type
Experimental
Arm Description
24 weeks physical activity program. 1 hour, 3 times a week, moderate to vigorous intensity.
Arm Title
No physical activity prescription
Arm Type
No Intervention
Arm Description
Provide information to patients about the benefits of physical activity and how to increase it safely.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity prescription to develop program in group.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity. Level of physical activity between intervention and control groups.
Description
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%.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Description
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.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Composite measure of biochemical markers: total cholesterol, triglycerides and fasting blood glucose
Description
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gallegos-Carrillo Katia, D. Sc
Organizational Affiliation
Instituto Mexicano del Seguro Social/Unidad de Investigación Epidemiologica y en Servicios de Salud.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62000
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
25011612
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.
Results Reference
derived
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Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
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