UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000533 |
|---|---|
| Receipt number | R000000644 |
| Scientific Title | Effect of Office-Based Short-duration High-Impact Exercise on Bone Mineral Density in Healthy Premenopausal Women |
| Date of disclosure of the study information | 2006/12/01 |
| Last modified on | 2010/08/17 13:45:07 |
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Basic information
Public title
Effect of Office-Based Short-duration High-Impact Exercise on Bone Mineral Density in Healthy Premenopausal Women
Acronym
OBB
Scientific Title
Effect of Office-Based Short-duration High-Impact Exercise on Bone Mineral Density in Healthy Premenopausal Women
Scientific Title:Acronym
OBB
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of office-based brief high impact exercise on bone quality of premenopausal women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone mineral density as assessed by DXA (lumbar spine L1-4, left femoral neck and trochanter), and by QUS(calcaneus)
Key secondary outcomes
Bone metabolism marker: cross-linked N. telopetide of type I Collagen(NTX); bone alkaline phosphatase(BAP)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
low-impact exercise: step exercise; 10-15 min/session; 3 sessions/week
Interventions/Control_2
high-impact exercise: 5 x10 (max) jumps inserted during low-impact exercise (step exercise); 10-15 min/session; 3 sessions/week
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
| 25 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
healthy premenopausal female
Key exclusion criteria
Medication of steroid hormone (corticosteroids, estrogen),
Metabolic diseases related to calcium turnover (hyper and hypothyroidism, hyper and hypo-parathyroidism etc)
Unable to complete 1 year intervention and examination
Pregnant
Within 1 year of delivery
Within 6 month of breast feeding
Ovariectomized
Diagnosed as osteoporosis
Patients with severe diseases such as cancer
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Nagatomi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Medicine and Science in Sports and Exercise
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8588
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Nagatomi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Medicine and Science in Sports and Exercise
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8588
Homepage URL
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Oulu Innovation;
Sendai City Industrial Promotion Organization
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan and Finland
Other related organizations
Co-sponsor
Sendai Collage; University of Oulu; National Institute of Health and Nutrition; Department of Orthopaedic Surgery, Tohoku University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.springerlink.com/content/j60855v7462krp57/
Number of participants that the trial has enrolled
Results
Ninety-one healthy premenopausal women were randomized to receive stretching exercise (SE) or HIE (stretching, along with up to 5 x 10 vertical and versatile jumps) for 12 months. The bone mineral density (BMD) of the lumbar spine and proximal femur was measured using dual-energy X-ray absorptiometry. Several cardiovascular risk factors and leg strength also were assessed. An accelerometer-based recorder was used to measure daily impact loading in four 1-week samples. The progression of the HIE program was ensured by the accelerometer. Thirty-three women (71.7%) in the SE group and 34 (75.6%) in the HIE group completed the study. There was a significant difference in the change in the femoral neck BMD between the groups in favor of the HIE group [0.6% (95% CI: 0.4, 1.7) vs. 1.0% (95% CI: 2.2, 0.2)]. Adiponectin, LDL, HDL, and the leg strength of participants in both the groups improved during the intervention. These finding suggested that office-based brief HIE can be recommended for premenopausal women for preventing bone mineral loss.
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
Completed
Date of protocol fixation
| 2006 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 30 | Day |
Last modified on
| 2010 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000644
