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NCT Number: NCT06981585

Physical Impairments in Children With Chronic Renal Failure

When the literature is examined, it is seen that the extent to which cough strength, grip strength, physical activity level and quality of life levels are affected in children with chronic kidney failure compared to healthy children is not sufficiently clarified. For this reason, this study aimed to reveal impairments in grip strength, cough strength, physical activity, sleep quality or quality of life in children with chronic renal failure compared to healthy children.

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Key information

Conditions

Chronic Kidney Failure Behavior Chronic Disease Chronic Kidney Diseases Disease Attributes Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Motor Activity Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İzmir Demokrasi Üniversitesi

Izmir, 35140, Turkey (Türkiye)

Location status: Recruiting

Location contact

GÜLŞAH BARĞI

CONTACT

[email protected]

+90 531 793 8766

HÜSEYİN KIRAN

CONTACT

About this study

The aim of this study is to compare children and adolescents with chronic kidney disease with healthy children and adolescents in terms of grip strength, cough strength, physical activity, sleep quality and quality of life. Participants will be evaluated for these parameters through clinical assessments, questionnaires and measurements. The aim of the study is to understand the health effects of chronic kidney disease and to provide the basis for improvements in the health management of these individuals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Children and Adolescents with Chronic Kidney Failure

  • Being between the ages of 8-18
  • Being clinically stable for at least the last 3 weeks
  • Having the necessary cooperation for the measurements
  • Being willing to participate in the study

Inclusion criteria

for Healthy Children and Adolescents:

  • Being between the ages of 8-18,
  • Having the necessary cooperation for the measurements,
  • Being willing to participate in the research

Exclusion criteria

for Children and Adolescents with Chronic Kidney Failure

  • Having any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months
  • Being a smoker or having quit
  • Having had a kidney transplant.

Exclusion criteria

for Healthy Children and Adolescents:

  • Having a history of any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months
  • Having any chronic disease
  • Being a smoker or having quit smoking

Treatment and study plan

Physical Evaluations of Patients with Chronic Kidney Failure

Other

In this study, data from children and adolescents with chronic kidney disease will be collected through face-to-face assessments. Grip strength, cough strength, physical activity, sleep quality and quality of life will be assessed in children and adolescents who meet the inclusion criteria. All data obtained through these assessments will be collected from participants face-to-face at one time and for a maximum of approximately 1 hour.

Physical Evaluations of Healthy Children

Other

In this study, data from healthy children and adolescents will be collected through face-to-face assessments. Grip strength, cough strength, physical activity, sleep quality and quality of life will be assessed in children and adolescents who meet the inclusion criteria. Data obtained through all these assessments will be collected from participants face-to-face at once and for a maximum of approximately 1 hour.

Primary outcomes

  1. Quality of life score

    Time frame: through study completion, an average of 1 year

    The scale we will use to assess health-related quality of life, the Pediatric Quality of Life Inventory (PedsQL 4.0). The scale was developed to assess the health-related quality of life of children and adolescents between the ages of 2 and 18 and consists of physical, emotional, social and school functioning items, totaling 23 items.Scores from this questionnaire are converted to a scale of 0 to 100. Higher scores indicate better health-related quality of life.

Secondary outcomes

  1. Cough Strength

    Time frame: through study completion, an average of 1 year

    The peak cough expiratory flow (PEF) of the individual will be assessed in the upright sitting position using a peak cough flow meter (PEF meter) (Expirite Peak Flow Meter, China). The individual coughs into the PEF meter as forcefully as possible following deep inspiration. The best of at least three repetitions is recorded.

  2. Hand Grip Strength

    Time frame: through study completion, an average of 1 year

    Grip strength will be measured using a dynamometer. Each hand will be tested three times, and the highest value will be recorded for both sides.

  3. Evaluation of Physical Activities

    Time frame: through study completion, an average of 1 year

    The Godin-Shephard leisure-time physical activity questionnaire will be used to determine the number of times individuals engage in physical activity during a one-week period. The questionnaireasks how many times individuals engage in physical activity lasting at least 15 minutes or longer during their free time over a 7-day period. This is used to calculate individuals' total physical activity scores. The higher the total score, the higher the individual's physical activity level. According to the score obtained from this questionnaire using moderate and strenuous physical activities; those who score 24 units or more are classified as Active (Significant benefits), those who score between 14-23 units are classified as Moderately active (Some benefits), and those who score less than 14 units are classified as Insufficiently active (Less important or low benefits).

  4. Evaluation of sleep quality

    Time frame: through study completion, an average of 1 year

    Children's Sleep Habits Questionnaire-Short Form will be used to evaluate sleep disorder in individuals and it consists of a total of 33 items.The total score is calculated.The lowest possible score for the questionnaire is 0, and the highest is 99. The higher the total score, the more sleep problems the individual has.

Study contacts

Contact information is provided by the study sponsor or research team.

Gülşah Barğı

CONTACT

[email protected]

+90 232 299 0739

Hüseyin Kıran

CONTACT

[email protected]

+90 531 706 8000

Sponsors and collaborators

Lead sponsor

Izmir Democracy University

Other

Registry information

Official study title

Comparison of Muscle Strength, Physical Activity, Sleep Quality and Quality of Life Between Children With Chronic Kidney Failure and Healthy Children

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 20, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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