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OpenTrials
Completed

NCT Number: NCT02636530

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ground Reaction Forces

Behavioral

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

Joint Reaction Forces

Behavioral

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

Primary outcomes

  1. Change in Volumetric Bone Mineral Density (vBMD)

    Time frame: Baseline and 6 month

    Measured via quantitative computed tomography (QCT)

  2. Change in Areal Bone Mineral Density (aBMD)

    Time frame: Baseline and 6 month

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

  3. Change in Bone Strength

    Time frame: Baseline and 6 month

    Measured via finite element analysis (FEA) from QCT

Secondary outcomes

  1. Change in 1-Repetition Maximum (1RM)

    Time frame: Baseline and 6 month

  2. Change in Maximal Oxygen Uptake (cardiovascular fitness)

    Time frame: Baseline and 6 month

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • VA Eastern Colorado Health Care System

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2015
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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