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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000533
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000644

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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