Effect of Two Exercise Programs on Bone Strength and Architecture

Osteoporosis Clinical Trial

Official title:

Effect of Two Exercise Programs on Bone Strength and Architecture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636530
• Other study ID #: 15-1451
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Ground Reaction Forces
6 month exercise program that loads the body via gravitational forces.
• Joint Reaction Forces
6 month exercise program that loads the body via loading the joints.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Veteran's Affairs Eastern Colorado Healthcare System	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Volumetric Bone Mineral Density (vBMD)	Measured via quantitative computed tomography (QCT)	Baseline and 6 month
Primary	Change in Areal Bone Mineral Density (aBMD)	Measured via dual-energy x-ray absorptiometry (DXA)	Baseline and 6 month
Primary	Change in Bone Strength	Measured via finite element analysis (FEA) from QCT	Baseline and 6 month
Secondary	Change in 1-Repetition Maximum (1RM)		Baseline and 6 month
Secondary	Change in Maximal Oxygen Uptake (cardiovascular fitness)		Baseline and 6 month