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Clinical Trials/NCT02636530
NCT02636530
Completed
Not Applicable

Effect of Two Exercise Programs on Bone Strength and Architecture

University of Colorado, Denver2 sites in 1 country48 target enrollmentJuly 1, 2016
ConditionsOsteoporosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
University of Colorado, Denver
Enrollment
48
Locations
2
Primary Endpoint
Change in Volumetric Bone Mineral Density (vBMD)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Bone responds according to the load placed on it. In this study, investigators want to know if exercise that loads the body in exercises, like walking or jogging (Ground Reaction Forces: GRF), affects bone differently than exercises that load the joints, like weight lifting (Joint Reaction Forces: JRF). Participants will exercise at least 3 times a week for 6 months. Measures of bone strength and mass, muscular strength, and aerobic fitness will be taken at the beginning and the end of the 6 month program. Period blood samples will be taken for future analysis of blood markers.

Registry
clinicaltrials.gov
Start Date
July 1, 2016
End Date
December 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • non-smoker
  • in generally good health
  • not physically active (less than 60 minutes of purposeful exercise/week)
  • able to travel to the exercise facility a minimum of 3 times/week

Exclusion Criteria

  • use of glucocorticoids
  • abnormal resting EKG
  • angina and/or evidence of acute myocardial ischemia during a treadmill test
  • resting blood pressure above 150 mmHg systolic of 90 mmHg diastolic
  • anti-resorptive drug use in the last 2 years
  • initiation of treatments that could impact bone metabolism (diuretics, hormones, bine anabolic agents) in the prior 6 months
  • dual-energy x-ray absorptiometry (DXA) t-score \<+ -2.5 at the femoral neck and/or lumbar spine
  • serum vitamin D concentration \<20 ng/mL
  • uncontrolled thyroid disease
  • any contraindications to regular exercise

Outcomes

Primary Outcomes

Change in Volumetric Bone Mineral Density (vBMD)

Time Frame: Baseline and 6 month

Measured via quantitative computed tomography (QCT)

Change in Areal Bone Mineral Density (aBMD)

Time Frame: Baseline and 6 month

Measured via dual-energy x-ray absorptiometry (DXA)

Change in Bone Strength

Time Frame: Baseline and 6 month

Measured via finite element analysis (FEA) from QCT

Secondary Outcomes

  • Change in 1-Repetition Maximum (1RM)(Baseline and 6 month)
  • Change in Maximal Oxygen Uptake (cardiovascular fitness)(Baseline and 6 month)

Study Sites (2)

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