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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017272
Receipt No. 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

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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
Email 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
Email s9082@nms.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery
Graduate School of Medicine
Chiba University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020033

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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