Exercise Capacity, Physical Fitness, and Physical Activity Levels in Children With CAH

NCT06449456 | Completed

• 1 other identifier: SBA 24/096
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Congenital Adrenal Hyperplasia; Exercise Capacity; Physical Activity; Quality of Life

Keywords

Congenital Adrenal Hyperplesia; Physical Fitness; Exercise Capacity; Physical Activity; Quality of Life; Heart Rate Variability - HRV

Outcome Measures

Primary Outcomes (6)

• 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.

  1 day

• Peripheral Muscle Strength

  Peripheral muscles'strength will be assessed using the K-Force hand dynamometer.

  1 day

• Physical Fitness Level

  It will be evaluated with the Fitnessgram test battery.

  1 day

• Functional Exercise Capacity

  It will be measured using the 6-Minute Walk Test.

  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.

  1 day

• Handgrip strength

  Jamar hand dynamometer (Jamar®, California, USA) will be used to measure grip strength.

  1 day

Secondary Outcomes (4)

• Anthropometric Measurements

  1 day

• Body composition

  1 day

• Participation

  1 day

• Heart Rate Variability

  1 day

Study Arms (2)

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

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Diagnosed with Congenital Adrenal Hyperplasia
• Aged between 8-18 years
• Providing voluntary consent from both themselves and their parents
• Able to cooperate

You may not qualify if:

• \- Having any systemic disease that may affect the measurement parameters
• Not having any chronic diseases
• Aged between 8-18 years
• Willing to participate in the study
• Able to cooperate
• Not willing to participate in the study
• Presence of cooperation and communication problems

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, State, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital; Motor Activity

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders; Behavior

Study Officials

• Ebru CALIK KUTUKCU, PhD

  Ankara, Hacettepe University, Türkiye, 06100 Contact: Phd 0903123051576 Ext.195 ecalik85@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 10, 2024
• Study Start: February 22, 2024
• Primary Completion: February 22, 2025
• Study Completion: February 22, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)