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Clinical Trials/NCT07333105
NCT07333105
Completed
Not Applicable

Whole Body Vibration Versus Aerobic Training on Interleukin 6 and Endurance After Renal Transplantation

Cairo University1 site in 1 country60 target enrollmentStarted: September 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
measurement of Interleukin-6

Overview

Brief Summary

This study aimed to compare the effect of whole body vibration versus aerobic training on interleukin 6 and endurance after renal transplantation in patients after renal transplantation.

Detailed Description

Even after a successful renal transplantation, the renal transplant recipients (RTRs) keeps on suffering the consequences of the uremic sickness such as increased cardiovascular risk, elevated level of inflammatory cytokines (IL6), decrease work capacity and quality of life. Since biological and psychological problems are not completely solved by pharmacological treatment, physical training is able both, to improve graft function, work capacity and quality of life, and to reduce cardiovascular risk Therefore, this research aims to investigate effect of the whole-body vibration versus stationary bicycle as modes of aerobic exercises on interleukin 6 in patients and the 6-minutes walk test after renal transplantation, which may reduce the risks of cardiovascular disease, produce improvement of the biology of transplantation, increase of energetic metabolism, and allows for a better quality of life in these subtypes of patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
30 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients of both sexes undergone renal transplantation.
  • Their age will range from 30-45 years old.
  • All patients will have the same medical and nursing care.
  • All the patients will receive a good explanation of treatment and measurement device.
  • They will be free from any genitourinary infections.
  • They will be neurologically free.

Exclusion Criteria

  • Uncooperative patients
  • Instability of patient's medical condition.
  • Association of another medical problem as heart disease and respiratory problems.
  • Diabetic patients.
  • Patients who have history of medical chronic relevant diseases.
  • Patients who have acute or chronic hepatitis.
  • Patients have pacemaker.
  • Patients who have genitourinary infections.
  • Previous history of epilepsy.

Arms & Interventions

whole body vibration

Experimental

In this group of the study, thirty renal transplant recipients' patients will receive the whole-body vibration for, 20 minutes 3 times per week for 12 weeks after one month post renal transplantation

Intervention: whole body vibration (Device)

stationary bicycle

Experimental

In this group, thirty renal transplant recipients' patients will receive aerobic exercise on stationary bicycle for 20 minutes 3 times per week for 12 weeks after one month post renal transplantation

Intervention: stationary bicycle (Device)

Outcomes

Primary Outcomes

measurement of Interleukin-6

Time Frame: at baseline and 12 weeks

Before starting the study, the following procedures will be performed. The purpose of the study will be clearly explained to each patient using simple and understandable language, and a written informed consent form will be obtained from each participant as an agreement to be included in the study. A venous blood sample (5 milliliters) will be collected from each subject in a sitting position under standardized conditions. The collected samples will be transferred into sterilized tubes containing tripotassium ethylenediaminetetraacetic acid (K3-EDTA) and heparinized tubes, which will be placed on ice and then kept at room temperature. Serum will be separated from plasma by centrifugation for 10 minutes. Interleukin-6 (IL-6) levels will be measured using the enzyme-linked immunosorbent assay (ELISA) technique with commercially available ELISA kits based on the immunoturbidimetric method. The normal reference range of interleukin-6 (IL-6) is 0-43.5 picograms per milliliter (pg/mL).

Secondary Outcomes

  • assessment of functional capacity(at baseline and 12 weeks)
  • assessment of endurance(at baseline and 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zeinab Adel Mohamed

Principal Investigator

Cairo University

Study Sites (1)

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