Effect of Two Exercise Programs on Bone Strength and Architecture

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Behavioral: Ground Reaction Forces; Behavioral: Joint Reaction Forces

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
    • Denver, Colorado, United States
      • Veteran's Affairs Eastern Colorado Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ground Reaction Forces; Participants will have an individualized exercise program that includes walking, jogging, stair climbing, and box jumping.	Behavioral: Ground Reaction Forces; 6 month exercise program that loads the body via gravitational forces.
Experimental: Joint Reaction Forces; Participants will have an individualized exercise program that includes weight lifting and aerobic rowing.	Behavioral: Joint Reaction Forces; 6 month exercise program that loads the body via loading the joints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Volumetric Bone Mineral Density (vBMD)	Measured via quantitative computed tomography (QCT)	Baseline and 6 month
Change in Areal Bone Mineral Density (aBMD)	Measured via dual-energy x-ray absorptiometry (DXA)	Baseline and 6 month
Change in Bone Strength	Measured via finite element analysis (FEA) from QCT	Baseline and 6 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in 1-Repetition Maximum (1RM)	Baseline and 6 month
Change in Maximal Oxygen Uptake (cardiovascular fitness)	Baseline and 6 month

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: VA Eastern Colorado Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 15-1451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No