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| Name | Class |
|---|---|
| NFL Charities | UNKNOWN |
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This is a single-center, randomized, double-blind (subject/evaluator)study. Enrolled patients had anterior cruciate ligament (ACL) reconstruction and met criteria for advanced rehabilitation. The study included 8 weeks of advanced rehabilitation consisting of low- or high-intensity plyometric exercise. The objective of the study was to determine the effect of plyometric exercise intensity on knee function and knee cartilage in patients with ACL reconstruction.
As part of the study, investigators will insure patients meet the criteria for advanced rehabilitation based on knee motion, pain levels and quadriceps strength.
Participants will be asked to review the informed consent and consent to the study prior to any study procedures. The study will consist of 2 testing sessions and an 8 week intervention (2 visits per week) at the UF&Shands Orthopaedics and Sports Medicine Institute. The testing sessions will include clinical measures of knee impairments, questionnaires, biomechanical analysis and functional performance testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plyometric Exercise - High intensity | Experimental | The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort). |
|
| Plyometric Exercise - Low intensity | Active Comparator | A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plyometric Exercise | Behavioral | Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Knee Documentation Committee (IKDC) Subjective Form Score. | The IKDC subjective form is a measure of self-reported knee function. It includes items related to symptoms and functional activities. Scores range from 0 to 100 points, and higher scores equal higher function. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score). | Baseline (pre-intervention) to 9 weeks (post-intervention) |
| Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II) | CTX-II is a biomarker of Type II collagen degradation. Early morning, second-void urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay and corrected for creatinine concentration, which will also be determined with enzyme-linked immunosorbent assay. Values will be log-transformed. The change in urinary CTX-II concentration will be computed as (post-intervention value minus pre-intervention value). | Baseline (pre-intervention) to 9 weeks (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vertical Jump Height. | Vertical jump height will be assessed with the Vertex. The average of three trials will be recorded in cm. The change in vertical jump height will be computed as (post-intervention value minus pre-intervention value). | Baseline (pre-intervention) to 9 weeks (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quadriceps Strength | Knee extensor torque will be measured with an isokinetic dynamometer. The lever arm will move at 60 degrees/second. The peak torque from 5 trials will be obtained and normalized to body weight. The change will be computed as (post-intervention value minus pre-intervention value) | Baseline (pre-intervention) to 9 weeks (post-intervention) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terese L Chmielewski, PT, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF&Shands Orthopaedics and Sports Medicine Institute | Gainesville | Florida | 32607 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26797700 | Derived | Chmielewski TL, George SZ, Tillman SM, Moser MW, Lentz TA, Indelicato PA, Trumble TN, Shuster JJ, Cicuttini FM, Leeuwenburgh C. Low- Versus High-Intensity Plyometric Exercise During Rehabilitation After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2016 Mar;44(3):609-17. doi: 10.1177/0363546515620583. Epub 2016 Jan 21. |
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25 subjects were consented to the study. One subject who was enrolled in the study was found to have insufficient quadriceps strength to participate in the study during baseline testing. She was withdrawn prior to randomization. 24 subjects were randomized to the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Plyometric Exercise - High Intensity | The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort). Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each). |
| FG001 | Plyometric Exercise - Low Intensity | A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort) Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Sample size was based on the minimal detectable change in IKDC-SKF scores and from urinary CTX-II concentrations in uninjured athletes.
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| ID | Title | Description |
|---|---|---|
| BG000 | Plyometric Exercise - High Intensity | The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort). Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each). |
| 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 International Knee Documentation Committee (IKDC) Subjective Form Score. | The IKDC subjective form is a measure of self-reported knee function. It includes items related to symptoms and functional activities. Scores range from 0 to 100 points, and higher scores equal higher function. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score). | Mean | Standard Deviation | units on a scale | Baseline (pre-intervention) to 9 weeks (post-intervention) |
|
Adverse events were compiled as they occurred.
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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 | Plyometric Exercise - High Intensity | The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort). Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject sustained injury to her surgical knee while performing an activity (skateboarding) that was not part of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terese Chmielewski | University of Florida | 352-273-6104 | tchm@ufl.edu |
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| ID | Term |
|---|---|
| D059385 | Plyometric Exercise |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Change in the Ratio of Urinary CTXII to Serum CPII Concentrations. |
CTX-II is a biomarker of Type II articular cartilage degradation. Type II collagen carboxy propeptide (CPII) is a biomarker of Type II collagen synthesis. Early morning urine and blood samples will be collected pre- and post-treatment. Urinary CTX-II will be analyzed as described in Primary Outcomes. Serum CPII will be determined using enzyme-linked immunosorbent assay. Values of both biomarkers will be log-transformed, and the ratio of CTXII:CPII will be calculated. The change will be computed as (post-intervention CTXII:CPII values minus pre-intervention CTXII:CPII value). |
| Baseline (pre-intervention) to 9 weeks (post-intervention) |
| Change in Fear of Movement/Re-injury | The 11-item version of the Tampa Scale for Kinesiophobia will be used to assess kinesiophobia or fear of movement/re-injury. Scores range from 11 to 44 points, and higher scores equal higher fear of movement/re-injury. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score). | Baseline (pre-intervention) to 9 weeks (post-intervention) |
| Change in Anterior Knee Laxity | Anterior knee laxity will be assessed with a knee arthrometer and a maximum manual pull. The side-to-side difference will be recorded in mm. The change will be computed as (post-intervention difference minus pre-intervention difference). | Baseline (pre-intervention) to 9 weeks (post-intervention) |
| BG001 | Plyometric Exercise - Low Intensity | A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort) Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Plyometric Exercise - Low Intensity | A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort) Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each). |
|
|
| Primary | Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II) | CTX-II is a biomarker of Type II collagen degradation. Early morning, second-void urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay and corrected for creatinine concentration, which will also be determined with enzyme-linked immunosorbent assay. Values will be log-transformed. The change in urinary CTX-II concentration will be computed as (post-intervention value minus pre-intervention value). | Mean | Standard Deviation | log-scale transformed value of ng/mmol | Baseline (pre-intervention) to 9 weeks (post-intervention) |
|
|
|
| Secondary | Change in Vertical Jump Height. | Vertical jump height will be assessed with the Vertex. The average of three trials will be recorded in cm. The change in vertical jump height will be computed as (post-intervention value minus pre-intervention value). | Mean | Standard Deviation | cm | Baseline (pre-intervention) to 9 weeks (post-intervention) |
|
|
|
| Secondary | Change in the Ratio of Urinary CTXII to Serum CPII Concentrations. | CTX-II is a biomarker of Type II articular cartilage degradation. Type II collagen carboxy propeptide (CPII) is a biomarker of Type II collagen synthesis. Early morning urine and blood samples will be collected pre- and post-treatment. Urinary CTX-II will be analyzed as described in Primary Outcomes. Serum CPII will be determined using enzyme-linked immunosorbent assay. Values of both biomarkers will be log-transformed, and the ratio of CTXII:CPII will be calculated. The change will be computed as (post-intervention CTXII:CPII values minus pre-intervention CTXII:CPII value). | Mean | Standard Deviation | log [(ng/mmol)/(ng/mL)] | Baseline (pre-intervention) to 9 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Change in Quadriceps Strength | Knee extensor torque will be measured with an isokinetic dynamometer. The lever arm will move at 60 degrees/second. The peak torque from 5 trials will be obtained and normalized to body weight. The change will be computed as (post-intervention value minus pre-intervention value) | Mean | Standard Deviation | ft-lb/lb | Baseline (pre-intervention) to 9 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Change in Fear of Movement/Re-injury | The 11-item version of the Tampa Scale for Kinesiophobia will be used to assess kinesiophobia or fear of movement/re-injury. Scores range from 11 to 44 points, and higher scores equal higher fear of movement/re-injury. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score). | Mean | Standard Deviation | units on a scale | Baseline (pre-intervention) to 9 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Change in Anterior Knee Laxity | Anterior knee laxity will be assessed with a knee arthrometer and a maximum manual pull. The side-to-side difference will be recorded in mm. The change will be computed as (post-intervention difference minus pre-intervention difference). | Mean | Standard Deviation | mm | Baseline (pre-intervention) to 9 weeks (post-intervention) |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Plyometric Exercise - Low Intensity | A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort) Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each). | 0 | 12 | 0 | 12 |
|
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |