Bone Adaptation to Impact Loading
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring acceleration, bone density, cardiovascular diseases, exercise, female, fragility fractures, impact intensity, intervention studies, osteoporosis, premenopause
Eligibility Criteria
Inclusion Criteria:
Random population-based sample of women:
- Age 35-40 yr
- residing in the city of Oulu, Finland
- in March 2002
Exclusion Criteria:
- cardiovascular, musculoskeletal, respiratory, or other chronic diseases that might limit training and testing
- diseases or medication affecting the bone
- pregnancy and breastfeeding
- regular current or previous participation in impact-type exercises and long-distance running more than three times a week
Sites / Locations
- University of Oulu
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
2
1
Arm Description
Control group
Exercise
Outcomes
Primary Outcome Measures
bone mineral density
Secondary Outcome Measures
muscle strength
Full Information
NCT ID
NCT00697957
First Posted
June 11, 2008
Last Updated
June 13, 2008
Sponsor
University of Oulu
Collaborators
Oulu Deaconess Institute, UKK Institute, Finnish Institute of Occupational Health, The Finnish Funding Agency for Technology and Innovation (TEKES), Newtest Ltd, CCC Group Ltd., Fastrax Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00697957
Brief Title
Bone Adaptation to Impact Loading
Official Title
Bone Adaptation to Impact Loading - Significance of Loading Intensity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oulu
Collaborators
Oulu Deaconess Institute, UKK Institute, Finnish Institute of Occupational Health, The Finnish Funding Agency for Technology and Innovation (TEKES), Newtest Ltd, CCC Group Ltd., Fastrax Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ageing populations have made osteoporosis and fragility fractures a major public health concern worldwide. Half of all women and 30% of all men will suffer a fracture related to osteoporosis during their lifetime. While medical prevention of this immense problem is impossible at population level, it is necessary to find efficient preventive strategies. Exercise is one of the major prevention approaches because one reason behind the increasing burden of osteoporosis is the modern sedentary lifestyle. However, the optimal type, intensity, frequency, and duration of exercise that best enhances skeletal integrity are still largely unknown.
We conducted a 12-month population-based randomized controlled exercise intervention in 120 premenopausal women. The aim was to investigate the effect of impact exercise on bone mineral density, geometry and metabolism in healthy women with the intention of assessing the intensity and amount of impact loading with a novel accelerometer-based measurement device. Training effects on risk factors of osteoporotic fractures, physical performance and risk factors of cardiovascular diseases were also evaluated.
This study demonstrated that 12 months of regular impact exercise favoured bone formation, increased bone mineral density in weight-bearing bones, especially at the hip, and led to geometric adaptations by increasing periosteal circumference. Bone adaptations had a dose- and intensity-dependent relationship with measured impact loading. Changes in proximal femur were threshold-dependent, indicating the importance of high impacts exceeding acceleration of 4 g as an osteogenic stimulus. The number of impacts needed to achieve this stimulation was 60 per day. Impact exercise also had a favourable effect on physical performance and cardiorespiratory risk factors by increasing maximal oxygen uptake, dynamic leg strength and decreasing low-density lipoproteins and waist circumference. Changes were dose-dependent with impact loading at wide intensity range.
Bone adapts to impact loading through various mechanisms to ensure optimal bone strength. The number of impacts needed to achieve bone stimulation appeared to be 60 per day, comparable to the same number of daily jumps. If done on a regular basis, impact exercise may be an efficient and safe way of preventing osteoporosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
acceleration, bone density, cardiovascular diseases, exercise, female, fragility fractures, impact intensity, intervention studies, osteoporosis, premenopause
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
No Intervention
Arm Description
Control group
Arm Title
1
Arm Type
Experimental
Arm Description
Exercise
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Progressive impact exercise
Primary Outcome Measure Information:
Title
bone mineral density
Time Frame
0 and 12 months
Secondary Outcome Measure Information:
Title
muscle strength
Time Frame
0 and 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Random population-based sample of women:
Age 35-40 yr
residing in the city of Oulu, Finland
in March 2002
Exclusion Criteria:
cardiovascular, musculoskeletal, respiratory, or other chronic diseases that might limit training and testing
diseases or medication affecting the bone
pregnancy and breastfeeding
regular current or previous participation in impact-type exercises and long-distance running more than three times a week
Facility Information:
Facility Name
University of Oulu
City
Oulu
ZIP/Postal Code
90014
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19909496
Citation
Ahola R, Korpelainen R, Vainionpaa A, Leppaluoto J, Jamsa T. Time-course of exercise and its association with 12-month bone changes. BMC Musculoskelet Disord. 2009 Nov 12;10:138. doi: 10.1186/1471-2474-10-138.
Results Reference
derived
Learn more about this trial
Bone Adaptation to Impact Loading
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