Back to resultsEffect of Two Exercise Programs on Bone Strength and Architecture
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ground Reaction Forces
Joint Reaction Forces
Sponsored by
About this trial
This is an interventional health services research trial for Osteoporosis
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
Sites / Locations
- University of Colorado Anschutz Medical Campus
- Veteran's Affairs Eastern Colorado Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ground Reaction Forces
Joint Reaction Forces
Arm Description
Participants will have an individualized exercise program that includes walking, jogging, stair climbing, and box jumping.
Participants will have an individualized exercise program that includes weight lifting and aerobic rowing.
Outcomes
Primary Outcome Measures
Change in Volumetric Bone Mineral Density (vBMD)
Measured via quantitative computed tomography (QCT)
Change in Areal Bone Mineral Density (aBMD)
Measured via dual-energy x-ray absorptiometry (DXA)
Change in Bone Strength
Measured via finite element analysis (FEA) from QCT
Secondary Outcome Measures
Change in 1-Repetition Maximum (1RM)
Change in Maximal Oxygen Uptake (cardiovascular fitness)
Full Information
NCT ID
NCT02636530
First Posted
December 17, 2015
Last Updated
January 6, 2022
Sponsor
University of Colorado, Denver
Collaborators
VA Eastern Colorado Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT02636530
Brief Title
Effect of Two Exercise Programs on Bone Strength and Architecture
Official Title
Effect of Two Exercise Programs on Bone Strength and Architecture
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
VA Eastern Colorado Health Care System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ground Reaction Forces
Arm Type
Experimental
Arm Description
Participants will have an individualized exercise program that includes walking, jogging, stair climbing, and box jumping.
Arm Title
Joint Reaction Forces
Arm Type
Experimental
Arm Description
Participants will have an individualized exercise program that includes weight lifting and aerobic rowing.
Intervention Type
Behavioral
Intervention Name(s)
Ground Reaction Forces
Intervention Description
6 month exercise program that loads the body via gravitational forces.
Intervention Type
Behavioral
Intervention Name(s)
Joint Reaction Forces
Intervention Description
6 month exercise program that loads the body via loading the joints.
Primary Outcome Measure Information:
Title
Change in Volumetric Bone Mineral Density (vBMD)
Description
Measured via quantitative computed tomography (QCT)
Time Frame
Baseline and 6 month
Title
Change in Areal Bone Mineral Density (aBMD)
Description
Measured via dual-energy x-ray absorptiometry (DXA)
Time Frame
Baseline and 6 month
Title
Change in Bone Strength
Description
Measured via finite element analysis (FEA) from QCT
Time Frame
Baseline and 6 month
Secondary Outcome Measure Information:
Title
Change in 1-Repetition Maximum (1RM)
Time Frame
Baseline and 6 month
Title
Change in Maximal Oxygen Uptake (cardiovascular fitness)
Time Frame
Baseline and 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Kohrt, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Veteran's Affairs Eastern Colorado Healthcare System
City
Denver
State/Province
Colorado
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Two Exercise Programs on Bone Strength and Architecture
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