UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017272 |
|---|---|
| Receipt number | R000020033 |
| Scientific Title | Effect of exercise for low back pain from osteoporosis and sarcopenia |
| Date of disclosure of the study information | 2015/04/24 |
| Last modified on | 2015/04/24 20:15:02 |
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Basic information
Public title
Effect of exercise for low back pain from osteoporosis and sarcopenia
Acronym
The effect of exercise for sarcopenia
Scientific Title
Effect of exercise for low back pain from osteoporosis and sarcopenia
Scientific Title:Acronym
The effect of exercise for sarcopenia
Region
| Japan |
Condition
Condition
osteoporosis and sarcopenia
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the superiority of combination therapy with exercise and drug therapy to drug therapy alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Transition of low back pain by Numerical Rating Scale
Key secondary outcomes
1)Bone density, muscle mass, muscle strength, changes in the body's ability
2)Changes in intramuscular fat degeneration
3)Changes in bone metabolism markers
4)Trends of low back pain (JOABPEQ)
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Drug therapy (bisphosphonate, vitamin D3) with exercise.
Interventions/Control_2
Drug therapy (bisphosphonate, vitamin D3) without exercise.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Osteoporosis patients. In DXA, bone density YAM is less than 80% in either of the lumbar spine or femur.
2) Patients that meet the definition of sarcopenia, who have muscle mass reduction, and either of decline of both sides grip strength (male; 25kg or less, female; 20kg or less) or walking speed (following 0.8 m / s). Walking ability is determined by the following interview, Can you cross the crosswalk during the green light?
3) Patients who agreed to participate in this study.
4) Patients who hope for drug prescription or exercise therapy on an outpatient basis.
5) Patients who have never taken bisphosphonates so far.
Key exclusion criteria
1) Patients who have done exercise therapy already.
2) Patients with thyroid dysfunction, pituitary dysfunction,or the parathyroid dysfunction.
3) Patients with acute spinal compression fracture (within 3 months after injury).Chronic fracture is not excluded.
4) Patients who have been determined to be unsuitable for this study by the investigator.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate School of Medicine
Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-226-2117
sohtori@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Fujimoto |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-226-2117
Homepage URL
s9082@nms.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery
Graduate School of Medicine
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Nihonseikeigekagakkai project research project research funds
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 24 | Day |
Last modified on
| 2015 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020033
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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