Overview

This trial is active, not recruiting.

Condition osteoporosis
Treatments ground reaction forces, joint reaction forces
Sponsor University of Colorado, Denver
Collaborator VA Eastern Colorado Healthcare System
Start date July 2016
End date February 2018
Trial size 50 participants
Trial identifier NCT02636530, 15-1451

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
Participants will have an individualized exercise program that includes walking, jogging, stair climbing, and box jumping.
ground reaction forces
6 month exercise program that loads the body via gravitational forces.
(Experimental)
Participants will have an individualized exercise program that includes weight lifting and aerobic rowing.
joint reaction forces
6 month exercise program that loads the body via loading the joints.

Primary Outcomes

Measure
Change in Volumetric Bone Mineral Density (vBMD)
time frame: Baseline and 6 month
Change in Areal Bone Mineral Density (aBMD)
time frame: Baseline and 6 month
Change in Bone Strength
time frame: Baseline and 6 month

Secondary Outcomes

Measure
Change in 1-Repetition Maximum (1RM)
time frame: Baseline and 6 month
Change in Maximal Oxygen Uptake (cardiovascular fitness)
time frame: Baseline and 6 month

Eligibility Criteria

Male or female participants from 60 years up to 75 years old.

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

Additional Information

Official title Effect of Two Exercise Programs on Bone Strength and Architecture
Principal investigator Rebecca Boxer, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.