NCT02636530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

5.4 years

First QC Date

December 17, 2015

Last Update Submit

January 6, 2022

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in 1-Repetition Maximum (1RM)

    Baseline and 6 month

  • Change in Maximal Oxygen Uptake (cardiovascular fitness)

    Baseline and 6 month

Study Arms (2)

Ground Reaction Forces

EXPERIMENTAL

Participants will have an individualized exercise program that includes walking, jogging, stair climbing, and box jumping.

Behavioral: Ground Reaction Forces

Joint Reaction Forces

EXPERIMENTAL

Participants will have an individualized exercise program that includes weight lifting and aerobic rowing.

Behavioral: Joint Reaction Forces

Interventions

Ground Reaction ForcesBEHAVIORAL

6 month exercise program that loads the body via gravitational forces.

Ground Reaction Forces
Joint Reaction ForcesBEHAVIORAL

6 month exercise program that loads the body via loading the joints.

Joint Reaction Forces

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Veteran's Affairs Eastern Colorado Healthcare System

Denver, Colorado, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wendy Kohrt, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 21, 2015

Study Start

July 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)