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Completed

NCT Number: NCT07333105

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

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.

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Key information

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alkahraba Hospital in Cairo

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Whole Body Vibration

Device

In a structured exercise session, subjects are instructed not to eat 2 hours prior and to wear comfortable clothing. They will rest for 10-15 minutes before starting, and will be barefoot to allow for proper vibration effects from the force platform, which induces lateral body oscillations. Before commencing, all parts of the whole-body vibration (WBV) device are checked for presence and functionality. The initial phase includes a 5-10 minute warm-up of stretching and marching. Over a 12-week period, subjects will undergo five 2-minute vibration treatments at 30 Hz, three times a week, followed by a 5-minute cool down. Participants are to stand upright with slightly flexed knees, ensuring their body alignment is maintained. Hand bars are available for those who feel insecure during the exercise.

stationary bicycle

Device

Thirty patients will undergo a supervised exercise program on a stationary bicycle for 12 weeks, exercising three times weekly. Each session will include a 5-minute warm-up (light walking), a 10-minute active phase (biking), and a 5-minute cool down (light walking). The total duration will be 20 minutes, with exercise intensity set at 60-70% of maximum heart rate, calculated using the Karvonen formula (maximum heart rate=220-Age). The walking speed will gradually increase from 60% to 70% of maximum heart rate over the course of the study.

Primary outcomes

  1. 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

  1. assessment of functional capacity

    Time frame: at baseline and 12 weeks

    Subjects will be instructed to walk from end to end at the corridor of the hospital at their own pace, while attempting to cover as much distance as possible 6 min test will be evaluated before conduction of the training program and after the completion of the study Stop watch will be used for the 6-minute walk test, the test is timed with a stopwatch and the distance covered in 6 minutes walk test is used as a means to compare changes in performance capacity

  2. assessment of endurance

    Time frame: at baseline and 12 weeks

    The 30-Second Chair Stand Test (30CST) evaluates leg strength and endurance in older adults as part of the Fullerton functional fitness test battery, designed to address limitations of other sit-to-stand tests. Conducted with a 17-inch folding chair, participants sit with feet shoulder-width apart and arms crossed. After a demonstration, they attempt to complete as many stands as possible in 30 seconds, maintaining proper form. Careful monitoring ensures only correctly executed stands are counted; the score reflects the total number completed, with results ranging from 0 to over 20, indicating varied fitness levels.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 13, 2026

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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