Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655181
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Evaluating the Effectiveness of Respiratory Muscle Training in Pediatric Kidney Transplant Patient
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of the Effectiveness of Respiratory Muscle Training in Children With Kidney Transplantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mlmin 173 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None