UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043253 |
|---|---|
| Receipt number | R000049349 |
| Scientific Title | Preliminary validation of whole-body vibration training for pain and muscle strength in middle-aged and older adults with early knee osteoarthritis. -A Non-Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/02/04 |
| Last modified on | 2021/02/04 23:14:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Preliminary validation of whole-body vibration training for pain and muscle strength in middle-aged and older adults with early knee osteoarthritis.
-A Non-Randomized Controlled Trial
Acronym
Preliminary validation of whole-body vibration training for pain and muscle strength in middle-aged and older adults with early knee osteoarthritis.
-A Non-Randomized Controlled Trial
Scientific Title
Preliminary validation of whole-body vibration training for pain and muscle strength in middle-aged and older adults with early knee osteoarthritis.
-A Non-Randomized Controlled Trial
Scientific Title:Acronym
Preliminary validation of whole-body vibration training for pain and muscle strength in middle-aged and older adults with early knee osteoarthritis.
-A Non-Randomized Controlled Trial
Region
| Japan |
Condition
Condition
early stage knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects and feasibility of whole-body vibration training on pain and muscle strength in middle-aged and elderly people with early-stage knee osteoarthritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 8 weeks post intervention
Key secondary outcomes
Weight ratio of isometric knee extensor strength and 30-second chair rise test at 8 weeks after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Regular physical therapy consisting of manual therapy, range of motion exercises, muscle strengthening exercises, and aerobic exercises will be performed at least twice a week for 8 weeks. In addition, whole body vibration training will be performed, with a protocol of 6 to 8 sets of 25 to 30 Hz for 30 to 45 seconds, at least twice a week.
Interventions/Control_2
Regular physical therapy consisting of manual therapy, range of motion exercises, muscle strengthening exercises, aerobic exercises, etc., at least twice a week for 8 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have experienced at least two episodes of pain lasting more than 10 days in the last year.
Patients with kellgren-lawrence grade 0-2 on x-ray.
Patients who have visited our clinic and are eligible for rehabilitation.
Key exclusion criteria
Those with a history of knee trauma or surgery.
Patients who have difficulty walking on their own.
Patients with obvious bone marrow lesion and symptoms
Patients with extreme frailty or sarcopenia.
Those with complications of diseases such as diabetes, cardiovascular, respiratory, malignant tumors, and systemic arthritis.
Patients with psychiatric disorders or neurological findings.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | takumi |
| Middle name | |
| Last name | manabe |
Organization
Fukuoka Reha Orthopedic Clinic
Division name
Rehabilitation Department
Zip code
819-8551
Address
7-770 Nokata, Nishi-ku, Fukuoka City, Fukuoka Prefecture
TEL
092-812-1880
tk.m64.b.kyt.8@gmail.com
Public contact
Name of contact person
| 1st name | takumi |
| Middle name | |
| Last name | manabe |
Organization
Fukuoka Reha Orthopedic Clinic
Division name
Rehabilitation Department
Zip code
819-8551
Address
7-770 Nokata, Nishi-ku, Fukuoka City, Fukuoka Prefecture
TEL
092-812-1880
Homepage URL
tk.m64.b.kyt.8@gmail.com
Sponsor or person
Institute
Fukuoka Reha Orthopedic Clinic
Rehabilitation Department
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Reha Orthopedic Clinic
Rehabilitation Department
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Reha Orthopedic Clinic
Address
7-770 Nokata, Nishi-ku, Fukuoka City, Fukuoka Prefecture
Tel
092-812-1880
tk.m64.b.kyt.8@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049349
