NCT00697957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2008

Completed
Last Updated

June 16, 2008

Status Verified

June 1, 2008

Enrollment Period

1.1 years

First QC Date

June 11, 2008

Last Update Submit

June 13, 2008

Conditions

Osteoporosis

Keywords

accelerationbone densitycardiovascular diseasesexercisefemalefragility fracturesimpact intensityintervention studiesosteoporosispremenopause

Outcome Measures

Primary Outcomes (1)

  • bone mineral density

    0 and 12 months

Secondary Outcomes (1)

  • muscle strength

    0 and 12 months

Study Arms (2)

2

NO INTERVENTION

Control group

1

EXPERIMENTAL

Exercise

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Progressive impact exercise

1

Eligibility Criteria

Age35 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Random population-based sample of women:
  • Age 35-40 yr
  • residing in the city of Oulu, Finland
  • in March 2002

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oulu

Oulu, 90014, Finland

Location

Related Publications (1)

  • 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.

    PMID: 19909496DERIVED

MeSH Terms

Conditions

OsteoporosisCardiovascular DiseasesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 16, 2008

Study Start

May 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

June 16, 2008

Record last verified: 2008-06

Locations

FI(1)