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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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The purpose of this study is to understand how different types of mechanical forces can influence bone adaptation (and make bones stronger, potentially). Forces acting on bones cause mechanical strain. In small animals, strain magnitude and rate have been shown to stimulate bone adaptation. This study is designed to test the degree to which strain magnitude and rate govern bone adaptation in healthy adult women.
The study consists of three Aims:
Aim 1: compare the effect on bone structure of mechanical signals with low strain magnitude, high strain magnitude, and control groups over a 12-month prospective period.
Aim 2. Compare the effect on bone structure of mechanical signals with low strain rate, high strain rate, and control groups over a 12-month prospective period.
Aim 3: Examine the effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.
The intervention is a voluntary forearm compression task, consisting of leaning onto the palm of the hand to produce a target force.
The primary outcome measure is change in distal radius bone mineral content (BMC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Magnitude | Experimental | voluntary forearm compression by leaning onto the palm of the hand with low target strain |
|
| High Magnitude | Experimental | voluntary forearm compression by leaning onto the palm of the hand with high target strain |
|
| Low Rate | Experimental | voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly") |
|
| High Rate | Experimental | voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump") |
|
| Control | No Intervention | observation only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voluntary forearm loading task | Other | voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in UD iBMC | 12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in UD cBMC | 12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in UD ecBMC | 12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29963602 | Result | Mancuso ME, Johnson JE, Ahmed SS, Butler TA, Troy KL. Distal radius microstructure and finite element bone strain are related to site-specific mechanical loading and areal bone mineral density in premenopausal women. Bone Rep. 2018 Apr 14;8:187-194. doi: 10.1016/j.bonr.2018.04.001. eCollection 2018 Jun. | |
| 32154945 | Result |
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Recruitment Period: December 2013-June 2017 All participants were recruited at a single site (Worcester Polytechnic Institute) and the surrounding community via social media, posters, email newsletters, and word of mouth at nearby universities, hospitals, and community events.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Magnitude | voluntary forearm compression by leaning onto the palm of the hand with low target strain voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| FG001 | High Magnitude | voluntary forearm compression by leaning onto the palm of the hand with high target strain voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| FG002 | Low Rate | voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly") voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| FG003 | High Rate | voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump") voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| FG004 | Control | observation only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Magnitude | voluntary forearm compression by leaning onto the palm of the hand with low target strain voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in UD iBMC | 12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | g | baseline and 12 months |
|
Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Magnitude | voluntary forearm compression by leaning onto the palm of the hand with low target strain voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary Wrist Soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Includes wrist soreness, potentially related to the intervention for exercise participants. Also includes other causes of wrist soreness such as overuse injury, sprain, and carpal tunnel for intervention and control groups. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Troy | Worcester Polytechnic Institute | 1-(508)-831-5000 | 6093 | ktroy@wpi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 25, 2018 | Oct 15, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2012 | Oct 15, 2019 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2016 | Oct 29, 2019 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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all data were blinded for analysis
|
| baseline and 12 months |
| Change in UD tBMC | 12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in UD iBMD | 12-month change in ultra-distal integral volumetric bone mineral density, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in UD cBMD | 12-month change in ultra-distal cortical volumetric bone mineral density, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in UD ecBMD | 12-month change in ultra-distal endocortical bone mineral density, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in UD tBMD | 12-month change in ultra-distal trabecular bone mineral density, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in UD iBV | 12-month change in ultra-distal integral bone volume, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in UD cBV | 12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in UD ecBV | 12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in UD tBV | 12-month change in ultra-distal trabecular bone volume, measured with quantitative computed tomography (QCT) | baseline and 12 months |
| Change in Cortical Thickness | Changes in cortical thickness at 3-month intervals, measured with high resolution peripheral quantitative computed tomography (HRpQCT) | measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment |
| Change in Trabecular BV/TV | trabecular bone volume fraction expressed as the ratio of bone volume (BV) to total volume (TV) using: (BV/TV). This quantity is measured with high resolution peripheral quantitative computed tomography (HRpQCT). It is expressed as a ratio, ranging from 0 (none of the volume is occupied by bone) to 1 (all of the volume is occupied by bone). | measurements repeated at 0, 3, 6, 9, and 12 months from enrollment |
| Troy KL, Mancuso ME, Johnson JE, Wu Z, Schnitzer TJ, Butler TA. Bone Adaptation in Adult Women Is Related to Loading Dose: A 12-Month Randomized Controlled Trial. J Bone Miner Res. 2020 Jul;35(7):1300-1312. doi: 10.1002/jbmr.3999. Epub 2020 Mar 30. |
| Pregnancy |
|
| Withdrawal by Subject |
|
| BG001 | High Magnitude | voluntary forearm compression by leaning onto the palm of the hand with high target strain voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| BG002 | Low Rate | voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly") voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| BG003 | High Rate | voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump") voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| BG004 | Control | observation only |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass | Mean | Standard Deviation | kg |
|
| Serum Vitamin D | circulating levels of 25-hydroxyvitamin D | Mean | Standard Deviation | ng/mL |
|
| Total Forearm aBMD | areal bone mineral density (BMD) in the Total region for the standard Forearm (Left or Right, non-dominant arm scanned) Analysis Protocol for the Hologic Discovery C densitometer. | Mean | Standard Deviation | g/cm^2 |
|
| DXA Total Forearm T-score | Dual energy x-ray absorptiometry (DXA) total forearm t-score. This is the forearm bone mineral density, expressed in numbers of standard deviations away from the average healthy young adult value. A t-score of 0 is equal to the mean. Scores less than 0 indicate lower bone density than a race and gender matched young healthy adult population and scores greater than 0 indicate higher bone density than a race and gender matched young healthy adult population. | Mean | Standard Deviation | t-score |
|
| Ultradistal iBMC | ultradistal integral bone mineral content measured using quantitative analysis of clinical resolution computed tomography (CT) scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | g |
|
| Ultradistal cBMC | ultradistal cortical bone mineral content measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | g |
|
| Ultradistal ecBMC | ultradistal endocortical bone mineral content measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | g |
|
| Ultradistal tBMC | ultradistal trabecular bone mineral content measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | g |
|
| Ultradistal iBV | ultradistal integral bone volume measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | cm^3 |
|
| Ultradistal cBV | ultradistal cortical bone volume measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | cm^3 |
|
| Ultradistal ecBV | ultradistal endocortical bone volume measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | cm^3 |
|
| Ultradistal tBV | ultradistal endocortical bone volume measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | cm^3 |
|
| Ultradistal iBMD | ultradistal integral volumetric bone mineral density measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | g/cm^3 |
|
| Ultradistal cBMD | ultradistal cortical volumetric bone mineral density measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | g/cm^3 |
|
| Ultradistal ecBMD | ultradistal endocortical volumetric bone mineral density measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | g/cm^3 |
|
| Ultradistal tBMD | ultradistal trabecular volumetric bone mineral density measured using quantitative computed tomography analysis of clinical resolution CT scans | All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes. | Mean | Standard Deviation | g/cm^3 |
|
| Trabecular BV/TV | trabecular bone volume fraction expressed as the ratio of bone volume (BV) to total volume (TV) using: (BV/TV). This quantity is measured with high resolution peripheral quantitative computed tomography (HRpQCT). It is expressed as a ratio, ranging from 0 (none of the volume is occupied by bone) to 1 (all of the volume is occupied by bone). | Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score <4). | Mean | Standard Deviation | ratio |
|
| Cortical Thickness | cortical thickness, measured with high resolution peripheral quantitative computed tomography (HRpQCT) | Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score <4 according to Pialat et al. (2012) Bone). | Mean | Standard Deviation | mm |
|
| OG002 | Low Rate | voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly") voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| OG003 | High Rate | voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump") voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. |
| OG004 | Control | observation only |
|
|
|
| Secondary | Change in UD cBMC | 12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | g | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD ecBMC | 12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | g | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD tBMC | 12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | g | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD iBMD | 12-month change in ultra-distal integral volumetric bone mineral density, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | g/cm^3 | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD cBMD | 12-month change in ultra-distal cortical volumetric bone mineral density, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | g/cm^3 | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD ecBMD | 12-month change in ultra-distal endocortical bone mineral density, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | g/cm^3 | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD tBMD | 12-month change in ultra-distal trabecular bone mineral density, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | g/cm^3 | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD iBV | 12-month change in ultra-distal integral bone volume, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | cm^3 | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD cBV | 12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | cm^3 | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD ecBV | 12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | cm^3 | baseline and 12 months |
|
|
|
|
| Secondary | Change in UD tBV | 12-month change in ultra-distal trabecular bone volume, measured with quantitative computed tomography (QCT) | Posted | Mean | Standard Deviation | cm^3 | baseline and 12 months |
|
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|
|
| Secondary | Change in Cortical Thickness | Changes in cortical thickness at 3-month intervals, measured with high resolution peripheral quantitative computed tomography (HRpQCT) | Analysis population includes participants analyzed at at least one interim timepoint. Exact values are provided for individual timepoints below. | Posted | Mean | Standard Deviation | mm | measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment |
|
|
|
|
| Secondary | Change in Trabecular BV/TV | trabecular bone volume fraction expressed as the ratio of bone volume (BV) to total volume (TV) using: (BV/TV). This quantity is measured with high resolution peripheral quantitative computed tomography (HRpQCT). It is expressed as a ratio, ranging from 0 (none of the volume is occupied by bone) to 1 (all of the volume is occupied by bone). | Analysis population includes participants analyzed at at least one interim timepoint. Exact values are provided for individual timepoints below. | Posted | Mean | Standard Deviation | ratio | measurements repeated at 0, 3, 6, 9, and 12 months from enrollment |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 8 |
| 21 |
| EG001 | High Magnitude | voluntary forearm compression by leaning onto the palm of the hand with high target strain voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. | 0 | 24 | 0 | 24 | 11 | 24 |
| EG002 | Low Rate | voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly") voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. | 0 | 21 | 0 | 21 | 10 | 21 |
| EG003 | High Rate | voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump") voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period. | 0 | 20 | 0 | 20 | 11 | 20 |
| EG004 | Control | observation only | 0 | 16 | 0 | 16 | 7 | 16 |
|
| Arm Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Elbow, shoulder, or hand pain, potentially related to the intervention or not related to the intervention. Includes several cases of aggravation of previous injuries potentially due to the intervention. |
|
| Other injury or pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Includes back and lower limb injuries not related to the intervention reported by participants in the load and control groups. |
|
| Anxiety | Psychiatric disorders | Systematic Assessment | Participant experienced anxiety during blood draw during the initial screening visit. |
|
| Wrist Bump | Musculoskeletal and connective tissue disorders | Systematic Assessment | Participant reported bump on wrist potentially related to the intervention. The bump went away 3 months after discontinuing the intervention. |
|
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
|
|
|
|
|
|
|
|
|
|
| The null hypothesis was that change in UD cBMC was not proportional to strain rate. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | 0.155 | Other | Overall model fit: R^2=0.107, F=1.971, df1=2, df2=33, p=0.155 Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.008, Beta=0.284, t=1.526, p=0.137, 95% CI of B: [-0.004, 0.027] Contrast between the high strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.008, Beta=0.342, t=1.837, p=0.075, 95% CI of B: [-0.002, 0.030] |
| The null hypothesis was that change in UD ecBMC was not proportional to strain rate. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | 0.018 | Other | Overall model fit: R^2=0.216, F=4.548, df1=2, df2=33, p=0.018 Contrast between the low strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.455, t=2.607, p=0.014, 95% CI of B: [0.006, 0.052] Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.447, t=2.563, p=0.015, 95% CI of B: [0.006, 0.052] |
| The null hypothesis was that change in UD tBMC was not proportional to strain rate. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | 0.001 | Other | Overall model fit: R^2=0.331, F=8.152, df1=2, df2=33, p=0.001 Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.004, Beta=0.473, t=2.930, p=0.006, 95% CI of B: [0.004, 0.020] Contrast between the high strain rate group and the control group: B=0.016, Std. Error of estimate of B=0.004, Beta=0.617, t=3.828, p=0.001, 95% CI of B: [0.008, 0.025] |
| The null hypothesis was that change in UD iBMD was not proportional to strain rate. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | <0.001 | Other | Overall model fit: R^2=0.563, F=21.225, df1=2, df2=33, p=<0.001 Contrast between the low strain rate group and the control group: B=0.009, Std. Error of estimate of B=0.002, Beta=0.739, t=5.669, p=<0.001, 95% CI of B: [0.005, 0.012] Contrast between the high strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.716, t=5.495, p=<0.001, 95% CI of B: [0.005, 0.012] |
| The null hypothesis was that change in UD cBMD was not proportional to strain rate. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | 0.381 | Other | Overall model fit: R^2=0.057, F=0.995, df1=2, df2=33, p=0.381 Contrast between the low strain rate group and the control group: B=0.004, Std. Error of estimate of B=0.003, Beta=0.254, t=1.327, p=0.194, 95% CI of B: [-0.002, 0.011] Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.003, Beta=0.038, t=0.200, p=0.843, 95% CI of B: [-0.006, 0.008] |
| The null hypothesis was that change in UD ecBMD was not proportional to strain rate. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | 0.018 | Other | Overall model fit: R^2=0.215, F=4.516, df1=2, df2=33, p=0.018 Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.005, Beta=0.484, t=2.773, p=0.009, 95% CI of B: [0.004, 0.0524] Contrast between the high strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.005, Beta=0.406, t=2.325, p=0.026, 95% CI of B: [0.001, 0.022] |
| The null hypothesis was that change in UD tBMD was not proportional to strain rate. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | <0.001 | Other | Overall model fit: R^2=0.480, F=15.256, df1=2, df2=33, p=<0.001 Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.590, t=4.153, p=<0.001, 95% CI of B: [0.004, 0.012] Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.002, Beta=0.734, t=5.164, p=<0.001, 95% CI of B: [0.006, 0.014] |
| The null hypothesis was that change in UD iBV was not proportional to strain rate. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | 0.344 | Other | Overall model fit: R^2=0.063, F=01.103, df1=2, df2=33, p=0.344 Contrast between the low strain rate group and the control group: B=0.015, Std. Error of estimate of B=0.025, Beta=0.113, t=0.595, p=0.556, 95% CI of B: [-0.036, 0.065] Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: [-0.014, 0.089] |
| The null hypothesis was that change in UD cBV was not proportional to strain rate. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | 0.289 | Other | Overall model fit: R^2=0.072, F=1.288, df1=2, df2=33, p=0.289 Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.018, Beta=0.154, t=0.814, p=0.422, 95% CI of B: [-0.022, 0.051] Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.018, Beta=0.304, t=1.604, p=0.118, 95% CI of B: [-0.008, 0.066] |
| The null hypothesis was that change in UD ecBV was not proportional to strain rate. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | 0.344 | Other | Overall model fit: R^2=0.063, F=1.103, df1=2, df2=33, p=0.344 Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.015, Beta=0.113, t=0.595, p=0.556, 95% CI of B: [-0.036, 0.065] Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: [-0.014, 0.089] |
| The null hypothesis was that change in UD tBV was not proportional to strain rate. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | 0.399 | Other | Overall model fit: R^2=0.054, F=0.946, df1=2, df2=33, p=0.399 Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.012, Beta=0.119, t=0.619, p=0.540, 95% CI of B: [-0.017, 0.032] Contrast between the high strain rate group and the control group: B=0.017, Std. Error of estimate of B=0.012, Beta=0.264, t=1.375, p=0.178, 95% CI of B: [-0.008, 0.042] |
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| 6 months |
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| 9 months |
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| 12 months |
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| The null hypothesis was that change in cortical thickness was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Other | At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests. At 3 months, there was a significant overall linear relationship between change in cortical thickness and strain rate group. Additionally, the coefficient representing the contrast between the control group and the high strain rate group was also significant. All other comparisons were not statistically significant (p>0.05). Stats for 3 months: Overall model fit: R^2=0.258, F=4.519, df1=2, df2=26, p=0.021 Contrast between the high strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.012, Beta=0.574, t=2.967, p=0.006, 95% CI of B: [0.011, 0.061] |
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| 6 months |
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| 9 months |
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| 12 months |
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| The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group. | Regression, Linear | >0.05 | Other | At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests. |