Physical InactivityNCT05461989
Physical Activity Barriers in Adolescent Hypertension Patients
An observational study of Physical Inactivity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
One of the most prevalent chronic disorders in children, especially teenagers, is hypertension . The prevalence of hypertension has significantly increased in recent years, particularly with the rise in obesity. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Anthropometric measurement, Level of Physical Activity and Physical Activity Barriers Scale
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2022to 1 Sep 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: adolescent primary and secondary hypertension patients
Who may be able to join
- Being 10-19 years old,
- Being diagnosed with primary hypertension,
- Being clinically stable and no drug/drug dose changes for the last four weeks,
- Determined to be voluntary to participate in the study
- Being 10-19 years old,
- Being diagnosed with secondary hypertension,
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- Being clinically stable and no drug/drug dose changes for the last four weeks,
- Not being under high-dose glucocorticoid therapy (2 mg/kg/day),
- Not taking intravenous biologic or conventional immunosuppressive therapy (including pulsed steroids) in the past month
- Determined to be voluntary to participate in the study
Who cannot join
- Having a neurological, cognitive or orthopedic disease that will affect the measurements,
- Severe respiratory system disease (FEV1 <35%; FVC <50%),
- Having acute infection,
- Having malignancy,
- Receiving hormone replacement therapy,
- Body mass index >40 kg/m²,
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- Ejection fraction less than 50%,
- Having uncontrolled hypertension,
- Individuals with diabetes will not be included in the study.
- For Secondary Hypertension
- Having a neurological, cognitive or orthopedic disease that will affect the measurements,
- Severe respiratory system disease (FEV1 <35%; FVC <50%),
- Having acute infection,
- Having malignancy,
- Receiving hormone replacement therapy,
- Body mass index >40 kg/m²,
- Ejection fraction less than 50%,
- Having uncontrolled hypertension,
- Individuals with diabetes will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
One of the most prevalent chronic disorders in children, especially teenagers, is hypertension . The prevalence of hypertension has significantly increased in recent years, particularly with the rise in obesity. It has been demonstrated that hypertension is a significant, controllable risk factor for cardiovascular disease and that it is linked to atherosclerosis in children. Additionally, in patients with hypertension who were monitored from infancy to adulthood, it was discovered that the unfavorable cardiac alterations and vascular damage linked to hypertension were linked to early cardiovascular disease in adults. Therefore, the key to preventing cardiovascular disease in children and adolescents-especially when risk factors like obesity, diabetes, or chronic renal disease are present-is early diagnosis and effective treatment of hypertension. Insufficient exercise and sedentary lifestyles are additional risk factors for pediatric hypertension.Investigating physical activity barrier in teenage hypertension patients is vital in light of all these factors as well as studies on adolescents' inadequate physical activity. The literature is lacking studies examining the obstacles to physical exercise faced by people with adolescent hypertension, hence this topic is open for investigation.
Read the detailed description
One of the most prevalent chronic disorders in children, especially teenagers, is hypertension . The prevalence of hypertension has significantly increased in recent years, particularly with the rise in obesity . Primary hypertension, also known as essential hypertension, which was once thought to be an adult condition, is becoming more prevalent in the pediatric population, partly because of the obesity pandemic . Children who are obese have a three times higher risk of developing hypertension than children who are not obese . Based on the etiology, hypertension can be divided into two types: primary or essential hypertension, which has no known cause, and secondary hypertension, which has a known cause. Stage I (mild) hypertension is the most common symptom of primary hypertension, which is also linked to a favorable family history . Very young children, those with stage II hypertension, and those with clinical signs suggesting systemic disorders linked to hypertension should all be evaluated for secondary hypertension. An underlying vascular, neurological, endocrine, or renal parenchymal illness may cause secondary hypertension .
It has been demonstrated that hypertension is a significant, controllable risk factor for cardiovascular disease and that it is linked to atherosclerosis in children. Additionally, in patients with hypertension who were monitored from infancy to adulthood, it was discovered that the unfavorable cardiac alterations and vascular damage linked to hypertension were linked to early cardiovascular disease in adults.Therefore, the key to preventing cardiovascular disease in children and adolescents-especially when risk factors like obesity, diabetes, or chronic renal disease are present-is early diagnosis and effective treatment of hypertension.
Insufficient exercise and sedentary lifestyles are additional risk factors for pediatric hypertension. Low levels of physical activity and hypertension have a continuous, temporal, and independent association, according to epidemiological research . According to data, 80% of kids and teenagers in 105 countries do not engage in the recommended amount of physical exercise, which is at least 60 minutes of moderate to strenuous activity per day.Additionally, many kids and teenagers engage in sedentary activities for more than 4 hours per day, even though less than 2 hours per day are advised for screen-based entertainment (such as watching TV, using a computer, and playing video games). According to research, children and adolescents who watch television or spend too much time on screens had lower fitness levels, worse self-esteem, less prosocial behavior, and higher systolic and diastolic blood pressure. Prospective research regularly demonstrates that exercise shields adults from high blood pressure. Physical activity has been dubbed a "poly-drug" for its preventive and therapeutic effects in reducing the global health burden of cardiovascular disease, increasing physiological function, and slowing cardiovascular aging.Investigating physical activity barrier in teenage hypertension patients is vital in light of all these factors as well as studies on adolescents' inadequate physical activity. The literature is lacking studies examining the obstacles to physical exercise faced by people with adolescent hypertension, hence this topic is open for investigation.
- Conditions
- Physical Inactivity
- Being tested
- Anthropometric measurement, Level of Physical Activity, Physical Activity Barriers Scale, Hand Grip Strength, Arterial stiffness
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthropometric measurementOther
It will be measured with the Xiaomi Body Composition Scale II, and a total of 9 measurements will be made as a result of the measurements.
Level of Physical ActivityOther
The scale to be used for this purpose is the Child Physical Activity Questionnaire (CPAQ) developed by Kowalski et al. It is a seven-day self-reported recall scale designed to assess moderate-intensity physical activity in children aged 8-14 years. CFAQ is designed to be implemented throughout the school year.
Physical Activity Barriers ScaleOther
It consists of three surveys in total, which are:
- Scale of Expectations Regarding Physical Activity for Children
- Children's perception of family support regarding physical activity scale
- Physical Activity Barriers Scale for Parents
Hand Grip StrengthOther
Hand grip strength will be measured using a hand dynamometer (Jamar, Sammons Preston, Rolyon, Bolingbrook, IL).
Arterial stiffnessOther
Arterial stiffness will be evaluated using the pulse wave velocity (PWV) technique with the blood pressure holter-ABPM (Mobil-O-Graph, I.E.M., Stolberg, Germany) device. The measurement is made from the non-dominant arm based on the principle of blood pressure measurement with the appropriate cuff determined according to the arm diameter. After two consecutive measurements taken 30 seconds apart, the average of the measurement values will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| primary hypertension | adolesence primary hypertension patients Receives: Other: Anthropometric measurement; Other: Level of Physical Activity; Other: Physical Activity Barriers Scale; Other: Hand Grip Strength; Other: Arterial stiffness | |
| secondary hypertension | adolesence secondary hypertension patients Receives: Other: Anthropometric measurement; Other: Level of Physical Activity; Other: Physical Activity Barriers Scale; Other: Hand Grip Strength; Other: Arterial stiffness |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity barriers
With a scale consisting of three questionnaires in total (Parent Physical Activity Barriers scale, the Child Physical Activity Outcome Expectancies Scale, and the Child Physical Activity Home Environment scale), the barriers of individuals to physical activity will be evaluated. As a result of these evaluations, it will guide us to understand the causes of physical activity barriers in primary and secondary hypertension patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start30 Sep 2022
- Primary completion30 Mar 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.Burcu ÖZCAN, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461989
- Sponsor's protocol ID
- GO 22/505
- Status last verified
- Apr 2024
- First submitted
- 9 Jul 2022
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Barriers in Adolescent Hypertension Patients
- ClinicalTrials.gov ID
- NCT05461989
- Acronym / sponsor ID
- GO 22/505
- Conditions
- Physical Inactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 18 Jul 2022 (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.
One of the most prevalent chronic disorders in children, especially teenagers, is hypertension . The prevalence of hypertension has significantly increased in recent years, particularly with the rise in obesity. It has been demonstrated that hypertension is a significant, controllable risk factor for cardiovascular disease and that it is linked to atherosclerosis in children. Additionally, in patients with hypertension who were monitored from infancy to adulthood, it was discovered that the unfavorable cardiac alterations and vascular damage linked to hypertension were linked to early cardiovascular disease in adults. Therefore, the key to preventing cardiovascular disease in children and adolescents-especially when risk factors like obesity, diabetes, or chronic renal disease are present-is early diagnosis and effective treatment of hypertension. Insufficient exercise and sedentary lifestyles are additional risk factors for pediatric hypertension.Investigating physical activity barrier in teenage hypertension patients is vital in light of all these factors as well as studies on adolescents' inadequate physical activity. The literature is lacking studies examining the obstacles to physical exercise faced by people with adolescent hypertension, hence this topic is open for investigation.
Detailed description
One of the most prevalent chronic disorders in children, especially teenagers, is hypertension . The prevalence of hypertension has significantly increased in recent years, particularly with the rise in obesity . Primary hypertension, also known as essential hypertension, which was once thought to be an adult condition, is becoming more prevalent in the pediatric population, partly because of the obesity pandemic . Children who are obese have a three times higher risk of developing hypertension than children who are not obese . Based on the etiology, hypertension can be divided into two types: primary or essential hypertension, which has no known cause, and secondary hypertension, which has a known cause. Stage I (mild) hypertension is the most common symptom of primary hypertension, which is also linked to a favorable family history . Very young children, those with stage II hypertension, and those with clinical signs suggesting systemic disorders linked to hypertension should all be evaluated for secondary hypertension. An underlying vascular, neurological, endocrine, or renal parenchymal illness may cause secondary hypertension .
It has been demonstrated that hypertension is a significant, controllable risk factor for cardiovascular disease and that it is linked to atherosclerosis in children. Additionally, in patients with hypertension who were monitored from infancy to adulthood, it was discovered that the unfavorable cardiac alterations and vascular damage linked to hypertension were linked to early cardiovascular disease in adults.Therefore, the key to preventing cardiovascular disease in children and adolescents-especially when risk factors like obesity, diabetes, or chronic renal disease are present-is early diagnosis and effective treatment of hypertension.
Insufficient exercise and sedentary lifestyles are additional risk factors for pediatric hypertension. Low levels of physical activity and hypertension have a continuous, temporal, and independent association, according to epidemiological research . According to data, 80% of kids and teenagers in 105 countries do not engage in the recommended amount of physical exercise, which is at least 60 minutes of moderate to strenuous activity per day.Additionally, many kids and teenagers engage in sedentary activities for more than 4 hours per day, even though less than 2 hours per day are advised for screen-based entertainment (such as watching TV, using a computer, and playing video games). According to research, children and adolescents who watch television or spend too much time on screens had lower fitness levels, worse self-esteem, less prosocial behavior, and higher systolic and diastolic blood pressure. Prospective research regularly demonstrates that exercise shields adults from high blood pressure. Physical activity has been dubbed a "poly-drug" for its preventive and therapeutic effects in reducing the global health burden of cardiovascular disease, increasing physiological function, and slowing cardiovascular aging.Investigating physical activity barrier in teenage hypertension patients is vital in light of all these factors as well as studies on adolescents' inadequate physical activity. The literature is lacking studies examining the obstacles to physical exercise faced by people with adolescent hypertension, hence this topic is open for investigation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary hypertension | – | Other: Anthropometric measurement, Other: Level of Physical Activity, Other: Physical Activity Barriers Scale, Other: Hand Grip Strength, Other: Arterial stiffnessadolesence primary hypertension patients |
| secondary hypertension | – | Other: Anthropometric measurement, Other: Level of Physical Activity, Other: Physical Activity Barriers Scale, Other: Hand Grip Strength, Other: Arterial stiffnessadolesence secondary hypertension patients |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- adolescent primary and secondary hypertension patients
Key inclusion criteria (10 listed)
- Being 10-19 years old,
- Being diagnosed with primary hypertension,
- Being clinically stable and no drug/drug dose changes for the last four weeks,
- Determined to be voluntary to participate in the study
- Being 10-19 years old,
Key exclusion criteria (19 listed)
- Having a neurological, cognitive or orthopedic disease that will affect the measurements,
- Severe respiratory system disease (FEV1 <35%; FVC <50%),
- Having acute infection,
- Having malignancy,
- Receiving hormone replacement therapy,
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 |
|---|---|---|
| Anthropometric measurementIt will be measured with the Xiaomi Body Composition Scale II, and a total of 9 measurements will be made as a result of the measurements. | Other | primary hypertension, secondary hypertension |
| Level of Physical ActivityThe scale to be used for this purpose is the Child Physical Activity Questionnaire (CPAQ) developed by Kowalski et al. It is a seven-day self-reported recall scale designed to assess moderate-intensity physical activity in children aged 8-14 years. CFAQ is designed to be implemented throughout the school year. | Other | primary hypertension, secondary hypertension |
| Physical Activity Barriers ScaleIt consists of three surveys in total, which are: A) Scale of Expectations Regarding Physical Activity for Children B) Children's perception of family support regarding physical activity scale C) Physical Activity Barriers Scale for Parents | Other | primary hypertension, secondary hypertension |
| Hand Grip StrengthHand grip strength will be measured using a hand dynamometer (Jamar, Sammons Preston, Rolyon, Bolingbrook, IL). | Other | primary hypertension, secondary hypertension |
| Arterial stiffnessArterial stiffness will be evaluated using the pulse wave velocity (PWV) technique with the blood pressure holter-ABPM (Mobil-O-Graph, I.E.M., Stolberg, Germany) device. The measurement is made from the non-dominant arm based on the principle of blood pressure measurement with the appropriate cuff determined according to the arm diameter. After two consecutive measurements taken 30 seconds apart, the average of the measurement values will be recorded. | Other | primary hypertension, secondary hypertension |
Primary outcome
physical activity barriers
Time frame: 12 months
With a scale consisting of three questionnaires in total (Parent Physical Activity Barriers scale, the Child Physical Activity Outcome Expectancies Scale, and the Child Physical Activity Home Environment scale), the barriers of individuals to physical activity will be evaluated. As a result of these evaluations, it will guide us to understand the causes of physical activity barriers in primary and secondary hypertension patients.
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 22 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Inactivity, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 10 inclusion and 19 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 22 Sep 2025. 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 Turkey (Türkiye). 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 barriers (time frame: 12 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 22 Sep 2025.