Congenital Adrenal HyperplasiaNCT06449456
Exercise Capacity, Physical Fitness, and Physical Activity Levels in Children With CAH
An observational study of Congenital Adrenal Hyperplasia and Exercise Capacity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Congenital Adrenal Hyperplesia (CAH) is a group of automosal recessive disorders that develop due to a deficiency of one of the five enyzmes necessary for cortisol synthesis in the adrenal cortex. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Adrenal Hyperplasia, Exercise Capacity, Physical Activity
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2024to 22 Feb 2025
- How long will I take part?
- 2 Days
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and adolescents aged 8-18 years diagnosed with classical congenital adrenal hyperplasia (CAH) who apply to and are followed up by the Hacettepe University Hospital, Pediatric Endocrinology Department will be accepted for the study. The snowball sampling method will be used for our control group. The investigators plan to contact the patient's relatives and then contact someone else in the same way.
Who may be able to join
- Diagnosed with Congenital Adrenal Hyperplasia
- Aged between 8-18 years
- Providing voluntary consent from both themselves and their parents
- Able to cooperate
- Not having any chronic diseases
- Aged between 8-18 years
- Willing to participate in the study
- Able to cooperate
Who cannot join
- Having any systemic disease that may affect the measurement parameters
- Not willing to participate in the study
- Presence of cooperation and communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Exercise Capacity, Muscle Functions, Physical Fitness, and Physical Activity Levels in Children With Congenital Adrenal Hyperplasia and Healthy Controls
Congenital Adrenal Hyperplesia (CAH) is a group of automosal recessive disorders that develop due to a deficiency of one of the five enyzmes necessary for cortisol synthesis in the adrenal cortex. Research indicates a predisposition in children and adolescents with CAH towards adverse metabolic changes such as obesity, hypertension, insulin resistance and increased intima-media thickness. This study aims to compare the extent to which children and adolescents with CAH are effected in terms of respiratory and peripheral muscle strength, exercise capasity, physical fitness and physical activity levels compared o their matched healthy individuals.
Read the detailed description
Congenital adrenal hyperplasia (CAH) is a group of autosomal recessive diseases caused by the deficiency of one of the five enzymes necessary for cortisol synthesis in the adrenal cortex. Dysfunction in cortisol synthesis, as seen in other enzyme deficiencies, leads to an increase in adrenocorticotropic hormone (ACTH) secretion, resulting in hypertension and hypokalemia. Additionally, patients with CAH exhibit excess androgens alongside cortisol deficiency. İn CAH treatment, glucocorticoids are used to suppress androgen production in the adrenal cortex. Deficiency in glucocorticoids and mineralocorticoids, as well as excess androgens, can contribute to the development of adverse metabolic and cardiovascular anomalies.
Ongoing research has revealed a predisposition for adverse metabolic changes in children and adolescents with CAH, including obesity, hypertension, insulin resistance, and increased intima-media thickness, which can increase the risk of developing cardiovascular disease in adulthood. Furthermore, subclinical left ventricular diastolic dysfunction has been observed in adolescents with CAH. İn these patients, due to the deficiency of epinephrine there is an increased tendency for hypoglycemia under stress conditions.
These metabolic changes can lead to impaired exercise performance in patients with CAH, consequently affecting their quality of life.
A study involving twenty classic CAH adolescents and twenty healthy counterparts demonstrated that classic CAH patients exhibited reduced exercise capacity with lower peak workload and higher peak systolic blood pressure during exercise. However, there is a lack of research in the literature comparing respiratory and peripheral muscle strength, daily life activities, physical fitness, and levels of physical activity in children and adolescents with CAH to their healthy peers.
- Keywords
- Congenital Adrenal Hyperplesia, Physical Fitness, Exercise Capacity, Physical Activity, Quality of Life, Heart Rate Variability - HRV
- Medical subject headings
- Adrenal Hyperplasia, Congenital, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Congenital Adrenal Hyperplasia | Patients between the ages of 8-18 years who have been diagnosed with Congenital Adrenal Hyperplasia | |
| Healthy Controls | Age and sex matched healthy controls between the ages of 8-18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength
Respiratory muscle strength will be measured using a portable, electronic mouth pressure measurement device (Micro Medical MicroMPM, UK). The best of three measurements for Maximal inspiratory pressure (MIP) and Maximal expiratory pressure (MEP) will be selected. Real MIP and MEP values and the percentages of expected values based on age and gender will be used in the analyses.
Measured: 1 day
Peripheral Muscle Strength
Peripheral muscles'strength will be assessed using the K-Force hand dynamometer.
Measured: 1 day
Physical Fitness Level
It will be evaluated with the Fitnessgram test battery.
Measured: 1 day
Functional Exercise Capacity
It will be measured using the 6-Minute Walk Test.
Measured: 1 day
Physical Activity Level
The Physical Activity Level will be assessed using the Physical Activity Questionnaire for Adolescents (PAQ-A) and the Physical Activity Questionnaire for Children (PAQ-C). The scores for PAQ-A and PAQ-C range from 9 to 45, with higher scores indicating better physical activity levels. The results of both questionnaires will be presented separately. The PAQ-A score will be reported as a distinct outcome measure for adolescents, and the PAQ-C score will be reported as a distinct Outcome Measure for children. This approach ensures a clear evaluation of physical activity levels in both age groups.
Measured: 1 day
Handgrip strength
Jamar hand dynamometer (Jamar®, California, USA) will be used to measure grip strength.
Measured: 1 day
Secondary outcomes (4)
Anthropometric Measurements
Anthropometric measurements will include separate measurements of waist and hip circumference, and calculations of the waist/hip ratio and waist/height ratio.
Measured: 1 day
Body composition
Body composition will be evaluated using bioelectric impedance analysis (Body Composition Analyzer MC-780MA). Measurements will include fat mass, fat-free mass, and water percentage. Each of these measurements will be reported as separate outcome measures. Fat mass will be reported in kilograms, fat-free mass in kilograms, and water percentage as a percentage of total body weight.
Measured: 1 day
Participation
Quality of life will be assessed using the Pediatric Outcome Data Collection Instrument (PODCI) child and adolescent form. Scores for all dimensions range from 0 to 100, with 100 indicating the highest level of function or participation.
Measured: 1 day
Heart Rate Variability
HRV will be assessed by measuring it with the Polar H10 device before, after, and during the recovery phase of the 6-minute walk test, specifically in the first and second minutes.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start22 Feb 2024
- Primary completion22 Feb 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Ebru CALIK KUTUKCU, PhD, Principal investigator, Ankara, Hacettepe University, Türkiye, 06100 Contact: Phd 0903123051576 Ext.195 ecalik85@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449456
- Sponsor's protocol ID
- SBA 24/096
- Status last verified
- Jul 2025
- First submitted
- 27 May 2024
- Last updated
- 8 Jul 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Exercise Capacity, Muscle Functions, Physical Fitness, and Physical Activity Levels in Children With Congenital Adrenal Hyperplasia and Healthy Controls
- ClinicalTrials.gov ID
- NCT06449456
- Acronym / sponsor ID
- SBA 24/096
- Keywords
- Congenital Adrenal Hyperplesia, Physical Fitness, Exercise Capacity, Physical Activity, Quality of Life, Heart Rate Variability - HRV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 10 Jun 2024 (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.
Congenital Adrenal Hyperplesia (CAH) is a group of automosal recessive disorders that develop due to a deficiency of one of the five enyzmes necessary for cortisol synthesis in the adrenal cortex. Research indicates a predisposition in children and adolescents with CAH towards adverse metabolic changes such as obesity, hypertension, insulin resistance and increased intima-media thickness. This study aims to compare the extent to which children and adolescents with CAH are effected in terms of respiratory and peripheral muscle strength, exercise capasity, physical fitness and physical activity levels compared o their matched healthy individuals.
Detailed description
Congenital adrenal hyperplasia (CAH) is a group of autosomal recessive diseases caused by the deficiency of one of the five enzymes necessary for cortisol synthesis in the adrenal cortex. Dysfunction in cortisol synthesis, as seen in other enzyme deficiencies, leads to an increase in adrenocorticotropic hormone (ACTH) secretion, resulting in hypertension and hypokalemia. Additionally, patients with CAH exhibit excess androgens alongside cortisol deficiency. İn CAH treatment, glucocorticoids are used to suppress androgen production in the adrenal cortex. Deficiency in glucocorticoids and mineralocorticoids, as well as excess androgens, can contribute to the development of adverse metabolic and cardiovascular anomalies.
Ongoing research has revealed a predisposition for adverse metabolic changes in children and adolescents with CAH, including obesity, hypertension, insulin resistance, and increased intima-media thickness, which can increase the risk of developing cardiovascular disease in adulthood. Furthermore, subclinical left ventricular diastolic dysfunction has been observed in adolescents with CAH. İn these patients, due to the deficiency of epinephrine there is an increased tendency for hypoglycemia under stress conditions.
These metabolic changes can lead to impaired exercise performance in patients with CAH, consequently affecting their quality of life.
A study involving twenty classic CAH adolescents and twenty healthy counterparts demonstrated that classic CAH patients exhibited reduced exercise capacity with lower peak workload and higher peak systolic blood pressure during exercise. However, there is a lack of research in the literature comparing respiratory and peripheral muscle strength, daily life activities, physical fitness, and levels of physical activity in children and adolescents with CAH to their healthy peers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Congenital Adrenal Hyperplasia | – | –Patients between the ages of 8-18 years who have been diagnosed with Congenital Adrenal Hyperplasia |
| Healthy Controls | – | –Age and sex matched healthy controls between the ages of 8-18 years |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 8-18 years diagnosed with classical congenital adrenal hyperplasia (CAH) who apply to and are followed up by the Hacettepe University Hospital, Pediatric Endocrinology Department will be accepted for the study. The snowball sampling method will be used for our control group. The investigators plan to contact the patient's relatives and then contact someone else in the same way.
Key inclusion criteria (8 listed)
- Diagnosed with Congenital Adrenal Hyperplasia
- Aged between 8-18 years
- Providing voluntary consent from both themselves and their parents
- Able to cooperate
- Not having any chronic diseases
Key exclusion criteria (3 listed)
- Having any systemic disease that may affect the measurement parameters
- Not willing to participate in the study
- Presence of cooperation and communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory Muscle Strength
Time frame: 1 day
Respiratory muscle strength will be measured using a portable, electronic mouth pressure measurement device (Micro Medical MicroMPM, UK). The best of three measurements for Maximal inspiratory pressure (MIP) and Maximal expiratory pressure (MEP) will be selected. Real MIP and MEP values and the percentages of expected values based on age and gender will be used in the analyses.
Peripheral Muscle Strength
Time frame: 1 day
Peripheral muscles'strength will be assessed using the K-Force hand dynamometer.
Physical Fitness Level
Time frame: 1 day
It will be evaluated with the Fitnessgram test battery.
Functional Exercise Capacity
Time frame: 1 day
It will be measured using the 6-Minute Walk Test.
Physical Activity Level
Time frame: 1 day
The Physical Activity Level will be assessed using the Physical Activity Questionnaire for Adolescents (PAQ-A) and the Physical Activity Questionnaire for Children (PAQ-C). The scores for PAQ-A and PAQ-C range from 9 to 45, with higher scores indicating better physical activity levels. The results of both questionnaires will be presented separately. The PAQ-A score will be reported as a distinct outcome measure for adolescents, and the PAQ-C score will be reported as a distinct Outcome Measure for children. This approach ensures a clear evaluation of physical activity levels in both age groups.
Handgrip strength
Time frame: 1 day
Jamar hand dynamometer (Jamar®, California, USA) will be used to measure grip strength.
4 secondary outcomes
Anthropometric Measurements
Time frame: 1 day
Body composition
Time frame: 1 day
Participation
Time frame: 1 day
Heart Rate Variability
Time frame: 1 day
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 8 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Congenital Adrenal Hyperplasia
RecruitingPhase 2/3
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
RecruitingPhase 3
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
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.
Ebru CALIK KUTUKCU, PhD principal investigator
Ankara, Hacettepe University, Türkiye, 06100 Contact: Phd 0903123051576 Ext.195 ecalik85@gmail.com
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 Congenital Adrenal Hyperplasia and Exercise Capacity, 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 8 inclusion and 3 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 8 Jul 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?
Respiratory Muscle Strength (time frame: 1 day). The study lists 6 primary outcomes in all. 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 8 Jul 2025.