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

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Respiratory Muscle Training; Pediatric Kidney Transplantation; Chronic Kidney Disease(CKD)
• Intervention / Treatment: Device: Respiratory Muscle Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul Atlas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants in the experimental group 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, the participants 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 participants in the experimental group will be adjusted to be calculated by measuring MIP-MEP again.	Device: Respiratory Muscle Training; Expiratory muscle training will be performed with POWERbreathe EX1 Medic (POWERbreathe®) device and inspiratory muscle training will be performed with POWERbreathe Medic Classic device.
Sham Comparator: Control Group; Participants in the control group 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. Patients in the control group will receive sham combined respiratory muscle training at the lowest constant load, twice a day for 20 minutes each, at least 5 days a week for a total of 8 weeks.	Device: Respiratory Muscle Training; Expiratory muscle training will be performed with POWERbreathe EX1 Medic (POWERbreathe®) device and inspiratory muscle training will be performed with POWERbreathe Medic Classic device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Function Test	Change from baseline forced vital capacity (FVC) at 8 weeks.	Eight weeks
Respiratory Function Test	Change from baseline peak expiratory flow (PEF) at 8 weeks.	Eight weeks
Functional Capacity	Change from baseline distance covered in six minute walk test at 8 weeks.	Eight weeks
Respiratory Function Test	Change from baseline FEV1/FVC at 8 weeks.	Eight weeks
Peripheral Muscle Strength	Change from baseline m. quadriceps strength at 8 weeks.	Eight weeks
Peripheral Muscle Strength	Change from baseline m. biceps strength at 8 weeks.	Eight weeks
Respiratory Function Test	Change from baseline forced forced expiratory volume in 1 (FEV1) second at 8 weeks.	Eight weeks
Respiratory Muscle Strength	Change from baseline maximum inspiratory pressure (MIP) at 8 weeks.	Eight weeks
Respiratory Muscle Strength	Change from baseline maximum expiratory pressure (MEP) at 8 weeks.	Eight weeks

Collaborators and Investigators

• Sponsor: Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): September 5, 2025

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: respiratory muscle training; Pediatric kidney transplantation
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Renal Insufficiency; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Renal Insufficiency, Chronic; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Breathing Exercises
• Other Study ID Numbers: AtlasUmkaya03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No