Bone Adaptation to Impact Loading

Osteoporosis Clinical Trial

Official title:

Bone Adaptation to Impact Loading - Significance of Loading Intensity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697957
• Other study ID #: 40093/02
• Status: Completed
• Phase: N/A
• First received: June 11, 2008
• Last updated: June 13, 2008
• Start date: May 2002
• Est. completion date: June 2003

Study information

• Verified date: June 2008
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Exercise
Progressive impact exercise

Locations

Country	Name	City	State
Finland	University of Oulu	Oulu

Sponsors (8)

Lead Sponsor	Collaborator
University of Oulu	CCC Group Ltd., Fastrax Ltd., Finnish Institute of Occupational Health, Newtest Ltd, Oulu Deaconess Institute, The Finnish Funding Agency for Technology and Innovation (TEKES), UKK Institute

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density		0 and 12 months	No
Secondary	muscle strength		0 and 12 months	No