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NCT Number: NCT06655181

Evaluating the Effectiveness of Respiratory Muscle Training in Pediatric Kidney Transplant Patient

Chronic kidney disease is defined as kidney damage lasting three months or longer and irreversible loss of renal function (glomerular, tubular and endocrine) or a glomerular filtration rate of less than 60 ml/min /1.73 m2 . Among the five stages of chronic kidney disease, the last and most severe stage is end-stage chronic kidney disease, which requires kidney transplantation. Many organs and systems are affected after kidney transplantation. Anemia, cardiovascular complications, secondary hyperparathyroidism, accumulation of uremic toxins, electrolyte disturbances, uremic myopathy, vitamin D deficiency, malnutrition, inflammation, atherosclerosis syndrome, and respiratory dysfunction and respiratory muscle weakness caused by oxidative stress leading to loss of muscle tissue are the most common changes seen in the pulmonary system. Children undergoing transplantation are at higher risk for cardiovascular diseases, usually associated with hypertension and dyslipidemia, which are already present in the chronic kidney disease stage and persist after transplantation. Significantly reduced muscle strength and physical activity in pediatric kidney transplant recipients is also frequently reported in the literature. Decreased exercise capacity, muscle strength and physical activity increase the risk of pulmonary and cardiovascular diseases. As chronic kidney disease progresses, pulmonary complications such as restrictive pulmonary dysfunction, respiratory muscle myopathy and decreased respiratory muscle strength are associated with disease severity. To improve respiratory muscle strength, respiratory muscle training is recommended for people with chronic kidney disease. The literature has so far demonstrated positive effects of inspiratory muscle training on respiratory muscle strength, diaphragm thickness and mobility, lung volumes, functional capacity and quality of life in many other patient populations, including lung and heart disease, cardiac surgery, thoracic surgery, multiple sclerosis and stroke. Although recent studies have found evidence of systemic changes after transplantation in both adults and children, there is little evidence of the efficacy of respiratory muscle training, especially in pediatric patients. In the light of all this information, the aim of our study was to investigate the efficacy of respiratory muscle training in children undergoing kidney transplantation.

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Key information

Conditions

Chronic Kidney Disease(CKD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric ALL Pediatric Kidney Transplantation Precursor Cell Lymphoblastic Leukemia-Lymphoma Renal Insufficiency Renal Insufficiency, Chronic Respiratory Muscle Training Urogenital Diseases Urologic Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

About this study

Kidney transplantation is the main treatment for patients with end-stage renal failure. Although kidney transplantation offers a good quality of life to patients, some of the complications caused by the underlying kidney disease and during end-stage renal failure persist in the follow-up of these patients, as well as many complications related to the drugs used after transplantation. As chronic kidney disease progresses, especially restrictive type respiratory dysfunction, respiratory muscle myopathy and decreased respiratory muscle strength are the most common changes seen in the pulmonary system. To improve respiratory muscle strength, respiratory muscle training is recommended for people with chronic kidney disease. There is limited scientific evidence on respiratory muscle training methods and outcomes in patients with chronic kidney disease, especially focusing only on inspiratory muscle training. Considering the heterogeneity of the studies and the variability of the results, the effectiveness of respiratory muscle training in patients with chronic kidney disease and especially after transplantation remains unclear. In the light of all this information, the aim of our study was to investigate the effectiveness of respiratory muscle training in children undergoing kidney transplantation. Patients will be randomly divided into two groups as experimental and control groups. According to the sample size calculation, it was determined that at least 15 people should be included in each group. Children in the experimental and control groups will be taught a home-based chest physiotherapy program (breathing exercises, teaching relaxation positions, cough training, respiratory control, respiratory control, physical activity recommendation) to be applied for 30 minutes a day, 5 days a week for 8 weeks. In addition to this program, patients in the experimental group will be given inspiratory and expiratory combined respiratory muscle training at 30% of MEP and MIP values for 8 weeks, 2 times a day for 20 minutes each, at least 5 days a week. The resistance setting of the patients in the experimental group will be adjusted to be calculated by measuring MIP-MEP again. Patients in the control group will receive sham combined respiratory muscle training for a total of 8 weeks at the lowest constant load, 2 times a day for 20 minutes each, at least 5 days a week.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being between 8-18 years old
  • At least 6 months have passed since kidney transplantation
  • Being able to walk, cooperate and clinically stable
  • Volunteering to participate in the study

Exclusion criteria

  • A history of hospitalization in the last four weeks before study participation History of hospitalization during the exercise training program
  • Having secondary diseases such as kyphoscoliosis that may affect respiratory function
  • Currently participating or have participated in regular exercise training in the last 1 year
  • Having neurological, psychiatric, orthopedic, cardiovascular and pulmonary system comorbid conditions that prevent the performance of tests and participation in the treatment program

Treatment and study plan

Respiratory Muscle Training

Device

Expiratory muscle training will be performed with POWERbreathe EX1 Medic (POWERbreathe®) device and inspiratory muscle training will be performed with POWERbreathe Medic Classic device.

Primary outcomes

  1. Respiratory Function Test

    Time frame: Eight weeks

    Change from baseline forced vital capacity (FVC) at 8 weeks.

  2. Respiratory Function Test

    Time frame: Eight weeks

    Change from baseline forced forced expiratory volume in 1 (FEV1) second at 8 weeks.

  3. Respiratory Function Test

    Time frame: Eight weeks

    Change from baseline peak expiratory flow (PEF) at 8 weeks.

  4. Respiratory Function Test

    Time frame: Eight weeks

    Change from baseline FEV1/FVC at 8 weeks.

  5. Respiratory Muscle Strength

    Time frame: Eight weeks

    Change from baseline maximum inspiratory pressure (MIP) at 8 weeks.

  6. Respiratory Muscle Strength

    Time frame: Eight weeks

    Change from baseline maximum expiratory pressure (MEP) at 8 weeks.

  7. Peripheral Muscle Strength

    Time frame: Eight weeks

    Change from baseline m. quadriceps strength at 8 weeks.

  8. Peripheral Muscle Strength

    Time frame: Eight weeks

    Change from baseline m. biceps strength at 8 weeks.

  9. Functional Capacity

    Time frame: Eight weeks

    Change from baseline distance covered in six minute walk test at 8 weeks.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

Investigation of the Effectiveness of Respiratory Muscle Training in Children With Kidney Transplantation

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Sep 8, 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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