Renal DialysisNCT07049718
Effect of Whole-body Vibration Training in Patients With Renal Dialysis
A study testing whole body vibration in people with Renal Dialysis, run by Cairo University at 1 site in Egypt.
Trial summary
To show the effect of whole-body vibration in physical performance in patients with renal dialysis. Read more about this study
- Who is it for?
- Ages 60 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2025to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients that will be included in this study will meet the following criteria:
- Body mass index (BMI) from 25.0 to 29.9 kg/m2.
- Quitting smoking for more than 3 months.
- Their age will be ranged from 60-70 years old.
- Clinically and medically stable.
- Hemodialysis treatment over at least 6 months before enrollment.
Show all 9Show fewer
- Patients with CKD (systolic blood pressure < 140 mmHg diastolic blood pressure < 90 mmHg and heart rate < 80 bpm).
- The presence of kidney damage (i.e., albuminuria) or decreased kidney function (i.e. glomerular filtration rate (GFR) < 60 ml/min per 1-73 m2) for 3 months or more irrespective of clinical diagnosis.
- -
Who cannot join
- Patients will be excluded if they have:
- Patients with uncontrolled pulmonary disease.
- Patients with vascular severe complication as critical limb ischemia.
- Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.
- Patients with severe musculoskeletal problems (e.g., severe knee osteoarthritis or post knee replacement surgeries).
- Any patients who missed more than two weeks of the program or want to terminate the program.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole-body Vibration Training on Bone Mineral Density and Physical Performance in Patient With Renal Dialysis
To show the effect of whole-body vibration in physical performance in patients with renal dialysis.
Read the detailed description
By now, safety and efficacy of WBV has not been investigated in patients with ESRD. Therefore, we performed this exploratory study in hemodialysis patients in order to elucidate potential effects of whole-body vibration exercise on physical performance and various biochemical markers in this condition. WBV is extensively studied as a means to prevent microgravity and immobility associated muscle wasting and bone loss in space flight and it is getting increasingly popular even among elderly.
Whole-body vibration exercise (WBVE) is a novel exercise protocol designed to prevent the loss of muscle strength and bone mineralization during the immobility and weightlessness of space flight.
A situation similar to HD. Vibration exercise uses high-frequency vibration of muscle groups causing positive feedback of the spinal reflex arc and resulting in high levels of muscle contraction to motor unit recruitment. There can be multiple physiological benefits from vibration exercise, including cardiovascular effects, bone health and muscle strength.
The advantages of WBV result from the combination of hardly any physical stress for the participants, short duration of intervention and a comparatively high effectiveness. means of exercise that can also be offered to those patients unable or unwilling to perform conventional training.
- Conditions
- Renal Dialysis
- Being tested
- whole body vibration
- Keywords
- Renal Dialysis, Whole-Body Vibration, Bone Mineral Density, Physical Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationDevice
Whole-body vibration (WBV) is a training method that uses mechanical vibration and external resistance loading to stimulate the body, causing muscle vibration and increasing central nervous system adaptations (Rittweger, 2010).
| Study group | Role | What they receive |
|---|---|---|
| whole body vibration group | Experimental | Thirty male patients will receive whole body vibration twice / week for 12 weeks with duration from 30 to 60secound until reach 20 minutes and intensity begin from initially 5 HZ until reach 28 HZ gradually increase each 4 weeks in addition to medication (Red Blood Cell Stimulating Agents, Iron, Blood Pressure Medications, Phosphate Binders, Vitamins B and C, Calcitriol, Cinacalcet and Antibiotics). Receives: Device: whole body vibration |
| control group | No intervention | Thirty male patients will receive their own medication only (Red Blood Cell Stimulating Agents, Iron, Blood Pressure Medications, Phosphate Binders, Vitamins B and C, Calcitriol, Cinacalcet and Antibiotics). |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
Blood sample to take bone mineral density. (calcium \& phosphorus)
Measured: 3 months
physical performance
For participant's functional status will be evaluated by a series of physical performance tests
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start15 Feb 2025
- Primary completion21 May 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Elsaid Ahmed Elsaid, Cairo University
- Investigators
- Abdelrahman Abdelmoniem, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049718
- Sponsor's protocol ID
- whole body vibration training
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zierle-Ghosh A, Jan A. Physiology, Body Mass Index. 2023 Nov 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK535456/
PubMed 30571077Zhanpeng F, Yan J, Fengrong Z, Sijie T. Estimation of peak oxygen pulse from body mass, resting heart rate, age, gender and systolic blood pressure in Chinese adults aged 20-39. Heliyon. 2023 Nov 4;9(11):e21912. doi: 10.1016/j.heliyon.2023.e21912. eCollection 2023 Nov.
PubMed 38027988Bai Y, Huang L, Yin X, Sun Q, Zhang F. Effects of whole-body vibration exercise on physical function in patients with chronic kidney disease: a systematic review and meta-analysis. BMC Nephrol. 2024 Jan 3;25(1):2. doi: 10.1186/s12882-023-03436-3.
PubMed 38172769van Heuvelen MJG, Rittweger J, Judex S, Sanudo B, Seixas A, Fuermaier ABM, Tucha O, Nyakas C, Marin PJ, Taiar R, Stark C, Schoenau E, Sa-Caputo DC, Bernardo-Filho M, van der Zee EA. Reporting Guidelines for Whole-Body Vibration Studies in Humans, Animals and Cell Cultures: A Consensus Statement from an International Group of Experts. Biology (Basel). 2021 Sep 27;10(10):965. doi: 10.3390/biology10100965.
PubMed 34681065Chen TK, Knicely DH, Grams ME. Chronic Kidney Disease Diagnosis and Management: A Review. JAMA. 2019 Oct 1;322(13):1294-1304. doi: 10.1001/jama.2019.14745.
PubMed 31573641Stenvinkel P, Carrero JJ, von Walden F, Ikizler TA, Nader GA. Muscle wasting in end-stage renal disease promulgates premature death: established, emerging and potential novel treatment strategies. Nephrol Dial Transplant. 2016 Jul;31(7):1070-7. doi: 10.1093/ndt/gfv122. Epub 2015 Apr 24.
PubMed 25910496Sietsema KE, Amato A, Adler SG, Brass EP. Exercise capacity as a predictor of survival among ambulatory patients with end-stage renal disease. Kidney Int. 2004 Feb;65(2):719-24. doi: 10.1111/j.1523-1755.2004.00411.x.
PubMed 14717947Seefried L, Genest F, Luksche N, Schneider M, Fazeli G, Brandl M, Bahner U, A Heidland A. Efficacy and safety of whole body vibration in maintenance hemodialysis patients - A pilot study. J Musculoskelet Neuronal Interact. 2017 Dec 1;17(4):268-274.
PubMed 29199185Howden EJ, Fassett RG, Isbel NM, Coombes JS. Exercise training in chronic kidney disease patients. Sports Med. 2012 Jun 1;42(6):473-88. doi: 10.2165/11630800-000000000-00000.
PubMed 22587820Rittweger J. Vibration as an exercise modality: how it may work, and what its potential might be. Eur J Appl Physiol. 2010 Mar;108(5):877-904. doi: 10.1007/s00421-009-1303-3. Epub 2009 Dec 12.
PubMed 20012646Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.
PubMed 28003033Marinho PEM, Rocha LG, Araujo Filho JC, Araujo AXP, Andrade MDA, Taiar R, Paiva DN, Dornelas de Andrade A. Effects of whole-body vibration on muscle strength, quadriceps muscle thickness and functional capacity in kidney transplant recipients: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:101-107. doi: 10.1016/j.jbmt.2020.10.005. Epub 2020 Oct 24.
PubMed 33992228Munhoz EC, Hollanda R, Vargas JP, Silveira CW, Lemos AL, Hollanda RM, Ribeiro JP. Flattening of oxygen pulse during exercise may detect extensive myocardial ischemia. Med Sci Sports Exerc. 2007 Aug;39(8):1221-6. doi: 10.1249/mss.0b013e3180601136.
PubMed 17762353Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
PubMed 22818936Johnstone, L. M., Roshanravan, B., Rundell, S. D., Kestenbaum, B., Baker, S. F., Berry, D. L., & McGough, E. (2022). Instrumented and standard measures of physical performance in adults with chronic kidney disease. Journal of Acute Care Physical Therapy, 13(3), 110-118.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-body Vibration Training on Bone Mineral Density and Physical Performance in Patient With Renal Dialysis
- ClinicalTrials.gov ID
- NCT07049718
- Acronym / sponsor ID
- whole body vibration training
- Conditions
- Renal Dialysis
- Keywords
- Renal Dialysis, Whole-Body Vibration, Bone Mineral Density, Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To show the effect of whole-body vibration in physical performance in patients with renal dialysis.
Detailed description
By now, safety and efficacy of WBV has not been investigated in patients with ESRD. Therefore, we performed this exploratory study in hemodialysis patients in order to elucidate potential effects of whole-body vibration exercise on physical performance and various biochemical markers in this condition. WBV is extensively studied as a means to prevent microgravity and immobility associated muscle wasting and bone loss in space flight and it is getting increasingly popular even among elderly.
Whole-body vibration exercise (WBVE) is a novel exercise protocol designed to prevent the loss of muscle strength and bone mineralization during the immobility and weightlessness of space flight.
A situation similar to HD. Vibration exercise uses high-frequency vibration of muscle groups causing positive feedback of the spinal reflex arc and resulting in high levels of muscle contraction to motor unit recruitment. There can be multiple physiological benefits from vibration exercise, including cardiovascular effects, bone health and muscle strength.
The advantages of WBV result from the combination of hardly any physical stress for the participants, short duration of intervention and a comparatively high effectiveness. means of exercise that can also be offered to those patients unable or unwilling to perform conventional training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole body vibration group | Experimental | Device: whole body vibrationThirty male patients will receive whole body vibration twice / week for 12 weeks with duration from 30 to 60secound until reach 20 minutes and intensity begin from initially 5 HZ until reach 28 HZ gradually increase each 4 weeks in addition to medication (Red Blood Cell Stimulating Agents, Iron, Blood Pressure Medications, Phosphate Binders, Vitamins B and C, Calcitriol, Cinacalcet and Antibiotics). |
| control group | No intervention | –Thirty male patients will receive their own medication only (Red Blood Cell Stimulating Agents, Iron, Blood Pressure Medications, Phosphate Binders, Vitamins B and C, Calcitriol, Cinacalcet and Antibiotics). |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body mass index (BMI) from 25.0 to 29.9 kg/m2.
- Quitting smoking for more than 3 months.
- Their age will be ranged from 60-70 years old.
- Clinically and medically stable.
- Hemodialysis treatment over at least 6 months before enrollment.
Key exclusion criteria (7 listed)
- Patients with uncontrolled pulmonary disease.
- Patients with vascular severe complication as critical limb ischemia.
- Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.
- Patients with severe musculoskeletal problems (e.g., severe knee osteoarthritis or post knee replacement surgeries).
- Any patients who missed more than two weeks of the program or want to terminate the program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibrationWhole-body vibration (WBV) is a training method that uses mechanical vibration and external resistance loading to stimulate the body, causing muscle vibration and increasing central nervous system adaptations (Rittweger, 2010). | Device | whole body vibration group |
Primary outcome
bone mineral density
Time frame: 3 months
Blood sample to take bone mineral density. (calcium \& phosphorus)
physical performance
Time frame: 3 months
For participant's functional status will be evaluated by a series of physical performance tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 30571077Zierle-Ghosh A, Jan A. Physiology, Body Mass Index. 2023 Nov 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK535456/
- Results publication: PubMed 38027988Zhanpeng F, Yan J, Fengrong Z, Sijie T. Estimation of peak oxygen pulse from body mass, resting heart rate, age, gender and systolic blood pressure in Chinese adults aged 20-39. Heliyon. 2023 Nov 4;9(11):e21912. doi: 10.1016/j.heliyon.2023.e21912. eCollection 2023 Nov.
- Results publication: PubMed 38172769Bai Y, Huang L, Yin X, Sun Q, Zhang F. Effects of whole-body vibration exercise on physical function in patients with chronic kidney disease: a systematic review and meta-analysis. BMC Nephrol. 2024 Jan 3;25(1):2. doi: 10.1186/s12882-023-03436-3.
- Results publication: PubMed 34681065van Heuvelen MJG, Rittweger J, Judex S, Sanudo B, Seixas A, Fuermaier ABM, Tucha O, Nyakas C, Marin PJ, Taiar R, Stark C, Schoenau E, Sa-Caputo DC, Bernardo-Filho M, van der Zee EA. Reporting Guidelines for Whole-Body Vibration Studies in Humans, Animals and Cell Cultures: A Consensus Statement from an International Group of Experts. Biology (Basel). 2021 Sep 27;10(10):965. doi: 10.3390/biology10100965.
- Results publication: PubMed 31573641Chen TK, Knicely DH, Grams ME. Chronic Kidney Disease Diagnosis and Management: A Review. JAMA. 2019 Oct 1;322(13):1294-1304. doi: 10.1001/jama.2019.14745.
- Results publication: PubMed 25910496Stenvinkel P, Carrero JJ, von Walden F, Ikizler TA, Nader GA. Muscle wasting in end-stage renal disease promulgates premature death: established, emerging and potential novel treatment strategies. Nephrol Dial Transplant. 2016 Jul;31(7):1070-7. doi: 10.1093/ndt/gfv122. Epub 2015 Apr 24.
- Results publication: PubMed 14717947Sietsema KE, Amato A, Adler SG, Brass EP. Exercise capacity as a predictor of survival among ambulatory patients with end-stage renal disease. Kidney Int. 2004 Feb;65(2):719-24. doi: 10.1111/j.1523-1755.2004.00411.x.
- Results publication: PubMed 29199185Seefried L, Genest F, Luksche N, Schneider M, Fazeli G, Brandl M, Bahner U, A Heidland A. Efficacy and safety of whole body vibration in maintenance hemodialysis patients - A pilot study. J Musculoskelet Neuronal Interact. 2017 Dec 1;17(4):268-274.
- Results publication: PubMed 22587820Howden EJ, Fassett RG, Isbel NM, Coombes JS. Exercise training in chronic kidney disease patients. Sports Med. 2012 Jun 1;42(6):473-88. doi: 10.2165/11630800-000000000-00000.
- Results publication: PubMed 20012646Rittweger J. Vibration as an exercise modality: how it may work, and what its potential might be. Eur J Appl Physiol. 2010 Mar;108(5):877-904. doi: 10.1007/s00421-009-1303-3. Epub 2009 Dec 12.
- Results publication: PubMed 28003033Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.
- Results publication: PubMed 33992228Marinho PEM, Rocha LG, Araujo Filho JC, Araujo AXP, Andrade MDA, Taiar R, Paiva DN, Dornelas de Andrade A. Effects of whole-body vibration on muscle strength, quadriceps muscle thickness and functional capacity in kidney transplant recipients: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:101-107. doi: 10.1016/j.jbmt.2020.10.005. Epub 2020 Oct 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelrahman Abdelmoniem principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration in people with Renal Dialysis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07049718, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.