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Effect of Two Exercise Programs on Bone Strength and Architecture

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT02636530
Collaborator
VA Eastern Colorado Health Care System (U.S. Fed)
48
Enrollment
2
Locations
2
Arms
65
Actual Duration (Months)
24
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Ground Reaction Forces
  • Behavioral: Joint Reaction Forces
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Effect of Two Exercise Programs on Bone Strength and Architecture
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Volumetric Bone Mineral Density (vBMD) [Baseline and 6 month]

    Measured via quantitative computed tomography (QCT)

  2. Change in Areal Bone Mineral Density (aBMD) [Baseline and 6 month]

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

  3. Change in Bone Strength [Baseline and 6 month]

    Measured via finite element analysis (FEA) from QCT

Secondary Outcome Measures

  1. Change in 1-Repetition Maximum (1RM) [Baseline and 6 month]

  2. Change in Maximal Oxygen Uptake (cardiovascular fitness) [Baseline and 6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045
2 Veteran's Affairs Eastern Colorado Healthcare System Denver Colorado United States

Sponsors and Collaborators

  • University of Colorado, Denver
  • VA Eastern Colorado Health Care System

Investigators

  • Principal Investigator: Wendy Kohrt, PhD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02636530
Other Study ID Numbers:
  • 15-1451
First Posted:
Dec 21, 2015
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoporosis

Study Results

No Results Posted as of Jan 11, 2022