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

NCT06655181 | Completed

• 1 other identifier: AtlasUmkaya03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease(CKD); Pediatric ALL; Pediatric Kidney Transplantation; Respiratory Muscle Training

Keywords

Pediatric kidney transplantation; respiratory muscle training

Outcome Measures

Primary Outcomes (9)

• Respiratory Function Test

  Change from baseline forced vital capacity (FVC) 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 Function Test

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

  Eight weeks

• Respiratory Function Test

  Change from baseline FEV1/FVC 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

• 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

• Functional Capacity

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

  Eight weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

SHAM COMPARATOR

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

Interventions

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: May 27, 2024
• Primary Completion: December 31, 2024
• Study Completion: September 5, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)