NCT00572104

Brief Summary

This study will compare the ability of two types of long term (12 months) weight-bearing exercise treatments (1. high-intensity jumping and 2. weight lifting) to increase bone mass of the total body, spine and hip in physically active men with osteopenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

5.8 years

First QC Date

December 10, 2007

Last Update Submit

October 6, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density

    12 months

Secondary Outcomes (2)

  • Serum markers of bone turnover

    3 months

  • Serum hormones regulating bone turnover

    3 months

Study Arms (2)

resistance exercise

EXPERIMENTAL

12 month resistance exercise training

Other: resistance exercise

plyometric exercise

EXPERIMENTAL

12 month plyometric exercise training

Other: plyometric exercise

Interventions

12 month training intervention of weight resistance exercise. All participants receive a daily calcium and vitamin D supplement

resistance exercise

12 month training intervention of plyometric exercise. All participants receive a daily calcium and vitamin D supplement

plyometric exercise

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age 25-60 years
  • No symptoms of disease
  • Currently participating in cycling activities an average of 4 hr/wk for the previous 24 months
  • Osteopenia of the lumbar spine and/or hip (T score \< -1.0 and \> -2.5 )

You may not qualify if:

  • Medications or supplements that affect bone metabolism or prevent exercise
  • Previous or current medical condition affecting bone health
  • Osteoporosis of the lumbar spine and/or hip (T score \> -1.0 or \< -2.5)
  • Cardiovascular disease
  • Metallic implants
  • Current smoker
  • Current regular participation in high-intensity resistance training and/or plyometrics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia; McKee Gym

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Resistance TrainingPlyometric Exercise

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pamela S Hinton

    University of Missouri-Columbia, Department of Nutritional Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 12, 2007

Study Start

January 1, 2008

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations