NCT07333105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 1, 2026

Last Update Submit

January 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • measurement of Interleukin-6

    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).

    at baseline and 12 weeks

Secondary Outcomes (2)

  • assessment of functional capacity

    at baseline and 12 weeks

  • assessment of endurance

    at baseline and 12 weeks

Study Arms (2)

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

Device: whole body vibration

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

Device: stationary bicycle

Interventions

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.

whole body vibration

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.

stationary bicycle

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alkahraba Hospital in Cairo

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 12, 2026

Study Start

September 1, 2023

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations