NCT05461989

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 22, 2025

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

July 9, 2022

Last Update Submit

September 16, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    12 months

Study Arms (2)

primary hypertension

adolesence primary hypertension patients

Other: Anthropometric measurementOther: Level of Physical ActivityOther: Physical Activity Barriers ScaleOther: Hand Grip StrengthOther: Arterial stiffness

secondary hypertension

adolesence secondary hypertension patients

Other: Anthropometric measurementOther: Level of Physical ActivityOther: Physical Activity Barriers ScaleOther: Hand Grip StrengthOther: Arterial stiffness

Interventions

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.

primary hypertensionsecondary hypertension

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.

primary hypertensionsecondary hypertension

It 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

primary hypertensionsecondary hypertension

Hand grip strength will be measured using a hand dynamometer (Jamar, Sammons Preston, Rolyon, Bolingbrook, IL).

primary hypertensionsecondary hypertension

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.

primary hypertensionsecondary hypertension

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

adolescent primary and secondary hypertension patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • For Secondary Hypertension
  • Being 10-19 years old,
  • Being diagnosed with secondary hypertension,
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Hand StrengthVascular Stiffness

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Muscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist (MSc)

Study Record Dates

First Submitted

July 9, 2022

First Posted

July 18, 2022

Study Start

September 30, 2022

Primary Completion

March 30, 2024

Study Completion

September 1, 2024

Last Updated

September 22, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations