OsteoporosisNCT02636530
Effect of Two Exercise Programs on Bone Strength and Architecture
A study testing Ground Reaction Forces and Joint Reaction Forces in people with Osteoporosis, run by University of Colorado, Denver at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Ground Reaction Forces and Joint Reaction Forces
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2016to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Veteran's Affairs Eastern Colorado Healthcare System
Denver, Colorado
About this study
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.
- Conditions
- Osteoporosis
- Being tested
- Ground Reaction Forces, Joint Reaction Forces
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ground Reaction ForcesBehavioural
6 month exercise program that loads the body via gravitational forces.
Joint Reaction ForcesBehavioural
6 month exercise program that loads the body via loading the joints.
| Study group | Role | What they receive |
|---|---|---|
| Ground Reaction Forces | Experimental | Participants will have an individualized exercise program that includes walking, jogging, stair climbing, and box jumping. Receives: Behavioral: Ground Reaction Forces |
| Joint Reaction Forces | Experimental | Participants will have an individualized exercise program that includes weight lifting and aerobic rowing. Receives: Behavioral: Joint Reaction Forces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Volumetric Bone Mineral Density (vBMD)
Measured via quantitative computed tomography (QCT)
Measured: Baseline and 6 month
Change in Areal Bone Mineral Density (aBMD)
Measured via dual-energy x-ray absorptiometry (DXA)
Measured: Baseline and 6 month
Change in Bone Strength
Measured via finite element analysis (FEA) from QCT
Measured: Baseline and 6 month
Secondary outcomes (2)
Change in 1-Repetition Maximum (1RM)
Measured: Baseline and 6 month
Change in Maximal Oxygen Uptake (cardiovascular fitness)
Measured: Baseline and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study start1 Jul 2016
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- VA Eastern Colorado Health Care System
- Responsible party
- Sponsor
- Investigators
- Wendy Kohrt, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636530
- Sponsor's protocol ID
- 15-1451
- Status last verified
- Jan 2022
- First submitted
- 17 Dec 2015
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Exercise Programs on Bone Strength and Architecture
- ClinicalTrials.gov ID
- NCT02636530
- Acronym / sponsor ID
- 15-1451
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- VA Eastern Colorado Health Care System
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ground Reaction Forces | Experimental | Behavioral: Ground Reaction ForcesParticipants will have an individualized exercise program that includes walking, jogging, stair climbing, and box jumping. |
| Joint Reaction Forces | Experimental | Behavioral: Joint Reaction ForcesParticipants will have an individualized exercise program that includes weight lifting and aerobic rowing. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ground Reaction Forces6 month exercise program that loads the body via gravitational forces. | Behavioural | Ground Reaction Forces |
| Joint Reaction Forces6 month exercise program that loads the body via loading the joints. | Behavioural | Joint Reaction Forces |
Primary outcome
Change in Volumetric Bone Mineral Density (vBMD)
Time frame: Baseline and 6 month
Measured via quantitative computed tomography (QCT)
Change in Areal Bone Mineral Density (aBMD)
Time frame: Baseline and 6 month
Measured via dual-energy x-ray absorptiometry (DXA)
Change in Bone Strength
Time frame: Baseline and 6 month
Measured via finite element analysis (FEA) from QCT
2 secondary outcomes
Change in 1-Repetition Maximum (1RM)
Time frame: Baseline and 6 month
Change in Maximal Oxygen Uptake (cardiovascular fitness)
Time frame: Baseline and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Kohrt, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ground Reaction Forces and Joint Reaction Forces in people with Osteoporosis, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Volumetric Bone Mineral Density (vBMD) (time frame: Baseline and 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.