HypertensionNCT05680025
Effect of a Physical Exercise Intervention Based on the Transtheoretical Model on Blood Pressure
A study testing Physical exercise intervention and Workshops in people with Hypertension, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Background: Hypertension is a public health problem; the World Health Organization (WHO) estimates that more than 1280 million people suffer it. The treatment of said condition is pharmacological and non-pharmacological. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Physical exercise intervention and Workshops
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteMexico
- Study dates
- 8 Aug 2022to 30 Aug 2024
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypertension.
- Patients from 40 to 70 years old.
- IMSS primary care users at UMF No. 1, in Aguascalientes.
- Patients who agree to participate in the study.
Who cannot join
- Patients with hypertension that have a medical contraindication for performing physical exercise, or whose health status suggests an individualized, supervised exercise plan (angina, arrhythmia, chronic kidney disease, lupus erythematosus).
- Patients who have some mental alteration that impedes answering the questionnaires or adequately following the established strategy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Physical Exercise Intervention Based on the Transtheoretical Model, on Blood Pressure in Patients With Hypertension, Insured by Mexican Institute of Social Security, in the State of Aguascalientes
Background: Hypertension is a public health problem; the World Health Organization (WHO) estimates that more than 1280 million people suffer it. The treatment of said condition is pharmacological and non-pharmacological. Physical activity is part of the treatment, but unfortunately few adults can be classified as physically active. There is evidence that performing physical exercise reduces systolic blood pressure by up to 5 mm Hg, which has associated with reduced heart disease by up to 9%, ictus up to 14% and all-cause mortality by 4%. Lifestyle changing interventions, among them promoting exercise marked by a theory of behavior change, have shown positive results. Objective: To evaluate the effect of an intervention promoting the performance of physical exercise, with specific recommendations, based on the Transtheoretical Model, on systolic blood pressure and on the amount of exercise performed (minutes/week) in patients with hypertension aged 40 to 70 years, users of primary care in the Mexican Institute for Social Security (IMSS) in Aguascalientes. Material and methods: Randomized clinical trial, in which 442 patients with hypertension will participate. The control group will receive conventional care and recommendations for physical exercise and diet. The intervention group, in addition, will attend 6 workshops, one a month, which will promote performing physical exercise, with access given to videos of physical exercise routines, designed to gradually increase the exercise performed. At the start and end of the study, blood pressure, anthropometric measurements will be taken, through a questionnaire asking about sociodemographic data, performance of physical exercise, psychosocial factors regarding physical exercise, diet and adherence to pharmacological treatment. The characteristics of the study population by group will be described, and changes between baseline and final measurements compared, intra and intergroup, in the systolic blood pressure and minutes/week of physical exercise.
- Conditions
- Hypertension
- Being tested
- Physical exercise intervention, Workshops
- Keywords
- Physical exercise, Transtheoretical Model, Lifestyle
- 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 exercise interventionBehavioural
The intervention group will have access to training videos through social networks (WhatsApp and YouTube) and infographics. The mobile phone of each of the participants will allow send dates of workshops, link for videos, messages reminding to perform exercise routines.
The training plan will be designed so the participants will achieve being physically active at the end of 6 months of intervention. Training will be planned to gradually, through 3 levels, increase the duration and intensity of exercises; they will have an important component of aerobic exercises and others for muscular strength. Each level of training will last two months; at each level the participants will be given 4 specific trainings and will be asked to perform two per week at level 1 and 2; and at the 3 level, 3 trainings per week.
The strategy for promoting physical exercise is based on the social cognitive theory, in which the bases of the transtheoretical model are found.
WorkshopsBehavioural
Six workshops to promote the performance of physical activity. The workshops will be held with groups of 15 participants. During them, the work will be to promote motivation to perform physical exercise, sharing information about the health benefits, benefits for control of the disease, together creating planning of measurable, realistic goals; reinforcing behavior when the desired advances are made, monitoring progress (using a monthly self-report of exercise performed). The participants will be motivated and congratulated each time for goals reached, self-sufficiency will be reinforced as well as greater evaluation of the advantages of performing exercise against the barriers or negative aspects perceived by the participants. These activities will be performed according to the level of exercise performed by the individuals (stage of change).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control group will be invited to attend two workshops, where they will be given and have explained a guide to physical activity and one for diet for patients with hypertension. In addition to pharmacological treatment, this is the information given as part of conventional treatment patients with hypertension receive from health care personnel. |
| Physical exercise intervention | Experimental | Promoting physical exercise. The intervention group will have access to training videos through social networks and infographics. Receives: Behavioral: Physical exercise intervention; Behavioral: Workshops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
This will be obtained through the difference in means between final systolic pressure (at 6 months from the start of the study) less the baseline.
Blood pressure will be determined after the participant's repose for 5 minutes, in a sitting position with the back supported against the chair, feet on the floor, the right arm at the height of the heart. The bracelet appropriate to the size of the arm will be used. Before measuring blood pressure by auscultation, the first number will be measured by palpitation. After these procedures and with an interval of 1 to 2 minutes, four measurements will be taken by the auscultator method, inflating the hose to 30 mm Hg above the figure in which pulse disappears and deflating at a rate of 2 mm Hg per second. The first noise of Korotkoff will be taken to define systolic pressure, and the disappearance of the Korotkoff noise marks diastolic pressure. The average of the last two takes will be used.
Measured: At baseline and at the end of the intervention (6 months)
Secondary outcomes (1)
Minutes of physical exercise per week
For the quantification of physical activity in minutes/week, the Physical Activity and Sedentary Behavior Questionnaire (Q-APCS) from the Canadian Society of the Physiology of Exercise and the Global Physical Activity Questionnaire will be used. The questionnaires will be applied at the start and finish of the study.
The Q-APCS is comprised of 7 questions about the number of days/week in a typical week that moderate and vigorous physical activity are performed, and on the duration in minutes of these activities, also asking about the number of days per week performing strength and muscular resistance exercise, and on the hours/day being seated, in work or school and during free time, and on the frequency light activities are performed when seated in sedentary behavior for various hours. Global Physical Activity Questionnaire includes questions about minutes/week during which physical activity is carried out in leisure time.
From this information, the minutes/week are calculated.
Measured: At baseline and at the end of the intervention (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start8 Aug 2022
- Primary completion15 Dec 2023
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ximena Duque López, Coordinación de Investigación en Salud, Mexico
- Investigators
- Ximena Duque, DS, Principal investigator, Instituto Mexicano del Seguro SocialSegundo Moran, DM, Study chair, Instituto Mexicano del Seguro SocialLaura Torres, Study chair, Instituto del Saber Montfort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680025
- Sponsor's protocol ID
- R-2021-101-054
- Status last verified
- May 2024
- First submitted
- 26 Dec 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Physical Exercise Intervention Based on the Transtheoretical Model, on Blood Pressure in Patients With Hypertension, Insured by Mexican Institute of Social Security, in the State of Aguascalientes
- ClinicalTrials.gov ID
- NCT05680025
- Acronym / sponsor ID
- R-2021-101-054
- Conditions
- Hypertension
- Keywords
- Physical exercise, Transtheoretical Model, Lifestyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 11 Jan 2023 (actual)
- 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.
Background: Hypertension is a public health problem; the World Health Organization (WHO) estimates that more than 1280 million people suffer it. The treatment of said condition is pharmacological and non-pharmacological. Physical activity is part of the treatment, but unfortunately few adults can be classified as physically active. There is evidence that performing physical exercise reduces systolic blood pressure by up to 5 mm Hg, which has associated with reduced heart disease by up to 9%, ictus up to 14% and all-cause mortality by 4%. Lifestyle changing interventions, among them promoting exercise marked by a theory of behavior change, have shown positive results. Objective: To evaluate the effect of an intervention promoting the performance of physical exercise, with specific recommendations, based on the Transtheoretical Model, on systolic blood pressure and on the amount of exercise performed (minutes/week) in patients with hypertension aged 40 to 70 years, users of primary care in the Mexican Institute for Social Security (IMSS) in Aguascalientes. Material and methods: Randomized clinical trial, in which 442 patients with hypertension will participate. The control group will receive conventional care and recommendations for physical exercise and diet. The intervention group, in addition, will attend 6 workshops, one a month, which will promote performing physical exercise, with access given to videos of physical exercise routines, designed to gradually increase the exercise performed. At the start and end of the study, blood pressure, anthropometric measurements will be taken, through a questionnaire asking about sociodemographic data, performance of physical exercise, psychosocial factors regarding physical exercise, diet and adherence to pharmacological treatment. The characteristics of the study population by group will be described, and changes between baseline and final measurements compared, intra and intergroup, in the systolic blood pressure and minutes/week of physical exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control group will be invited to attend two workshops, where they will be given and have explained a guide to physical activity and one for diet for patients with hypertension. In addition to pharmacological treatment, this is the information given as part of conventional treatment patients with hypertension receive from health care personnel. |
| Physical exercise intervention | Experimental | Behavioral: Physical exercise intervention, Behavioral: WorkshopsPromoting physical exercise. The intervention group will have access to training videos through social networks and infographics. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with hypertension.
- Patients from 40 to 70 years old.
- IMSS primary care users at UMF No. 1, in Aguascalientes.
- Patients who agree to participate in the study.
Key exclusion criteria (2 listed)
- Patients with hypertension that have a medical contraindication for performing physical exercise, or whose health status suggests an individualized, supervised exercise plan (angina, arrhythmia, chronic kidney disease, lupus erythematosus).
- Patients who have some mental alteration that impedes answering the questionnaires or adequately following the established strategy.
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 exercise interventionThe intervention group will have access to training videos through social networks (WhatsApp and YouTube) and infographics. The mobile phone of each of the participants will allow send dates of workshops, link for videos, messages reminding to perform exercise routines. The training plan will be designed so the participants will achieve being physically active at the end of 6 months of intervention. Training will be planned to gradually, through 3 levels, increase the duration and intensity of exercises; they will have an important component of aerobic exercises and others for muscular strength. Each level of training will last two months; at each level the participants will be given 4 specific trainings and will be asked to perform two per week at level 1 and 2; and at the 3 level, 3 trainings per week. The strategy for promoting physical exercise is based on the social cognitive theory, in which the bases of the transtheoretical model are found. | Behavioural | Physical exercise intervention |
| WorkshopsSix workshops to promote the performance of physical activity. The workshops will be held with groups of 15 participants. During them, the work will be to promote motivation to perform physical exercise, sharing information about the health benefits, benefits for control of the disease, together creating planning of measurable, realistic goals; reinforcing behavior when the desired advances are made, monitoring progress (using a monthly self-report of exercise performed). The participants will be motivated and congratulated each time for goals reached, self-sufficiency will be reinforced as well as greater evaluation of the advantages of performing exercise against the barriers or negative aspects perceived by the participants. These activities will be performed according to the level of exercise performed by the individuals (stage of change). | Behavioural | Physical exercise intervention |
Primary outcome
Change in systolic blood pressure
Time frame: At baseline and at the end of the intervention (6 months)
This will be obtained through the difference in means between final systolic pressure (at 6 months from the start of the study) less the baseline. Blood pressure will be determined after the participant's repose for 5 minutes, in a sitting position with the back supported against the chair, feet on the floor, the right arm at the height of the heart. The bracelet appropriate to the size of the arm will be used. Before measuring blood pressure by auscultation, the first number will be measured by palpitation. After these procedures and with an interval of 1 to 2 minutes, four measurements will be taken by the auscultator method, inflating the hose to 30 mm Hg above the figure in which pulse disappears and deflating at a rate of 2 mm Hg per second. The first noise of Korotkoff will be taken to define systolic pressure, and the disappearance of the Korotkoff noise marks diastolic pressure. The average of the last two takes will be used.
1 secondary outcome
Minutes of physical exercise per week
Time frame: At baseline and at the end of the intervention (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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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.
Ximena Duque, DS principal investigator
Instituto Mexicano del Seguro Social
Segundo Moran, DM study chair
Instituto Mexicano del Seguro Social
Laura Torres study chair
Instituto del Saber Montfort
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 exercise intervention and Workshops 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 4 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: status not confirmed, as of the sponsor's last update on 29 May 2024. 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?
Results are not available in the source record.
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?
Change in systolic blood pressure (time frame: At baseline and at the end of the intervention (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024.