Whole Body Vibration Versus Aerobic Training on Interleukin 6 and Endurance After Renal Transplantation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Alkahraba Hospital in Cairo
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: whole body vibration
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
|
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.
|
|
Experimental: stationary bicycle
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
at baseline and 12 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at baseline and 12 weeks
|
|
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.
|
at baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- Zeinab-phd
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.