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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara

Other trials in Turkey (Türkiye)

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.

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:

    1. Scale of Expectations Regarding Physical Activity for Children
    2. Children's perception of family support regarding physical activity scale
    3. 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 groups in NCT05461989
Study groupRoleWhat they receive
primary hypertensionadolesence 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 hypertensionadolesence 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.

  1. 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.

  1. First posted18 Jul 2022
  2. Study start30 Sep 2022
  3. Primary completion30 Mar 2024
  4. Study completion1 Sep 2024

Resources

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
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

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.

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