HemodialysisNCT04774731
Effect of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients
A study testing Whole Body Vibration in people with Hemodialysis, run by Osaka University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of whole body vibration for 12 weeks on walking performance in elderly hemodialysis patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Whole Body Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2021to 30 Mar 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Undergoing maintenance hemodialysis three times a week .
Who cannot join
- Having difficulty in walking by oneself.
- Having difficulty in receiving whole body vibration training because of cognitive impairment.
- History of fracture of lower limb within 1 year.
- History of total hip arthroplasty.
- Unsuitable for participant in the trial by an attending physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients
The purpose of this study is to evaluate the efficacy of whole body vibration for 12 weeks on walking performance in elderly hemodialysis patients.
Read the detailed description
This is a multicenter, prospective, randomized controlled trial. Eligible subjects will be randomized in a 1:1 ratio to a whole-body vibration (WBV) group or controlled group. Patients in a WBV group will receive WBV training three times a week before initiation of dialysis sessions for 12 weeks. The primary outcome of the study will be the change in walking performance assessed by the timed up and go test.
- Conditions
- Hemodialysis
- Being tested
- Whole Body Vibration
- Keywords
- whole body vibration, hemodialysis, gait function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationOther
Receiving WBV training three times a week before initiation of dialysis sessions for 12 weeks. Subjects stand on a platform of WBV for 3 minutes in every training session.
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration | Experimental | Not described Receives: Other: Whole Body Vibration |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the timed up and go test
Measured: 12 weeks after starting intervention
Secondary outcomes (2)
Change in the one-leg standing test
Measured: 12 weeks after starting intervention
Change in the 30-second chair-stand test
Measured: 12 weeks after starting intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Apr 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuke Sakaguchi, Osaka University
- Investigators
- Yusuke Sakaguchi, MD, PhD, Principal investigator, Department of Nephrology, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774731
- Sponsor's protocol ID
- WBV-HD
- Status last verified
- Sep 2022
- First submitted
- 24 Feb 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Asahina Y, Sakaguchi Y, Kajimoto S, Hattori K, Oka T, Kaimori JY, Kashihara N, Isaka Y. A Randomized Controlled Trial of Whole-Body Vibration on Gait Ability and Balance among Older Hemodialysis Patients. Clin J Am Soc Nephrol. 2023 Jan 1;18(1):84-90. doi: 10.2215/CJN.0000000000000018.
PubMed 36719160
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04774731
- Acronym / sponsor ID
- WBV-HD
- Conditions
- Hemodialysis
- Keywords
- whole body vibration, hemodialysis, gait function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 1 Mar 2021 (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.
The purpose of this study is to evaluate the efficacy of whole body vibration for 12 weeks on walking performance in elderly hemodialysis patients.
Detailed description
This is a multicenter, prospective, randomized controlled trial. Eligible subjects will be randomized in a 1:1 ratio to a whole-body vibration (WBV) group or controlled group. Patients in a WBV group will receive WBV training three times a week before initiation of dialysis sessions for 12 weeks. The primary outcome of the study will be the change in walking performance assessed by the timed up and go test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration | Experimental | Other: Whole Body Vibration |
| Control | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Undergoing maintenance hemodialysis three times a week .
Key exclusion criteria (5 listed)
- Having difficulty in walking by oneself.
- Having difficulty in receiving whole body vibration training because of cognitive impairment.
- History of fracture of lower limb within 1 year.
- History of total hip arthroplasty.
- Unsuitable for participant in the trial by an attending physician.
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 VibrationReceiving WBV training three times a week before initiation of dialysis sessions for 12 weeks. Subjects stand on a platform of WBV for 3 minutes in every training session. | Other | Whole Body Vibration |
Primary outcome
Change in the timed up and go test
Time frame: 12 weeks after starting intervention
2 secondary outcomes
Change in the one-leg standing test
Time frame: 12 weeks after starting intervention
Change in the 30-second chair-stand test
Time frame: 12 weeks after starting intervention
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 21 Sep 2022.
- Derived from this study: PubMed 36719160Asahina Y, Sakaguchi Y, Kajimoto S, Hattori K, Oka T, Kaimori JY, Kashihara N, Isaka Y. A Randomized Controlled Trial of Whole-Body Vibration on Gait Ability and Balance among Older Hemodialysis Patients. Clin J Am Soc Nephrol. 2023 Jan 1;18(1):84-90. doi: 10.2215/CJN.0000000000000018.
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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.
Yusuke Sakaguchi, MD, PhD principal investigator
Department of Nephrology, Osaka 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 Hemodialysis, run by Osaka University at 1 site in Japan.
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 1 inclusion and 5 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 21 Sep 2022. 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 Japan. 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?
Change in the timed up and go test (time frame: 12 weeks after starting intervention). 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 NCT04774731, which also lists 1 linked publication.
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 21 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.