NCT01910935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 6, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

July 5, 2013

Last Update Submit

June 4, 2014

Conditions

Hypertension

Keywords

Physical activityHypertensionScheme referencePrimary care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Blood pressure

    24 weeks

Other Outcomes (1)

  • Composite measure of biochemical markers: total cholesterol, triglycerides and fasting blood glucose

    24 weeks

Study Arms (2)

Physical activity prescription

EXPERIMENTAL

24 weeks physical activity program. 1 hour, 3 times a week, moderate to vigorous intensity.

Behavioral: Physical activity prescription to develop program in group.

No physical activity prescription

NO INTERVENTION

Provide information to patients about the benefits of physical activity and how to increase it safely.

Interventions

Physical activity prescription to develop program in group.BEHAVIORAL

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.

Physical activity prescription

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23

Cuernavaca, Morelos, 62000, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 25011612DERIVED

MeSH Terms

Conditions

HypertensionMotor Activity

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Gallegos-Carrillo Katia, D. Sc

    Instituto Mexicano del Seguro Social/Unidad de Investigación Epidemiologica y en Servicios de Salud.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2013

First Posted

July 30, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

April 1, 2014

Last Updated

June 6, 2014

Record last verified: 2014-02

Locations

ME(1)