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

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ClinicalTrials.gov Identifier: NCT01910935
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Physical activity prescription to develop program in group. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
Study Start Date : July 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical activity prescription
24 weeks physical activity program. 1 hour, 3 times a week, moderate to vigorous intensity.
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.

No Intervention: No physical activity prescription
Provide information to patients about the benefits of physical activity and how to increase it safely.



Primary Outcome Measures :
  1. Physical activity. Level of physical activity between intervention and control groups. [ Time Frame: 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 :
  1. Blood pressure [ Time Frame: 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.


Other Outcome Measures:
  1. Composite measure of biochemical markers: total cholesterol, triglycerides and fasting blood glucose [ Time Frame: 24 weeks ]
    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.



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910935


Locations
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Mexico
Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23
Cuernavaca, Morelos, Mexico, 62000
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: Gallegos-Carrillo Katia, D. Sc Instituto Mexicano del Seguro Social/Unidad de Investigación Epidemiologica y en Servicios de Salud.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01910935    
Other Study ID Numbers: 2009-785-038
FIS/IMSS/PROT/G10/841 ( Other Identifier: FIS/IMSS )
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: February 2014
Keywords provided by Coordinación de Investigación en Salud, Mexico:
Physical activity
Hypertension
Scheme reference
Primary care
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases