HypertensionNCT01910935
Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
A study testing Physical activity prescription to develop program in group. in people with Hypertension, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Physical activity prescription to develop program in group.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23
Cuernavaca, Morelos, 62000
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Physical activity prescription to develop program in group.
- Keywords
- Physical activity, Hypertension, Scheme reference, Primary care
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity prescription to develop program in group.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity prescription | Experimental | 24 weeks physical activity program. 1 hour, 3 times a week, moderate to vigorous intensity. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 24 weeks
Secondary outcomes (1)
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gallegos-Carrillo Katia, D. Sc, Principal investigator, Instituto Mexicano del Seguro Social/Unidad de Investigación Epidemiologica y en Servicios de Salud.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910935
- Sponsor's protocol ID
- 2009-785-038
- Other IDs
- FIS/IMSS/PROT/G10/841
- Status last verified
- Feb 2014
- First submitted
- 5 Jul 2013
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25011612
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
- ClinicalTrials.gov ID
- NCT01910935
- Acronym / sponsor ID
- 2009-785-038
- Conditions
- Hypertension
- Keywords
- Physical activity, Hypertension, Scheme reference, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity prescription | Experimental | Behavioral: Physical activity prescription to develop program in group.24 weeks physical activity program. 1 hour, 3 times a week, moderate to vigorous intensity. |
| No physical activity prescription | No intervention | –Provide information to patients about the benefits of physical activity and how to increase it safely. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Physical activity prescription |
Primary outcome
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%.
1 secondary outcome
Blood pressure
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Derived from this study: PubMed 25011612Gallegos-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gallegos-Carrillo Katia, D. Sc principal investigator
Instituto Mexicano del Seguro Social/Unidad de Investigación Epidemiologica y en Servicios de Salud.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity prescription to develop program in group. in people with Hypertension, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity. Level of physical activity between intervention and control groups. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.