Trial Outcomes & Findings for Anterior Cruciate Ligament Reconstruction and Plyometric Exercise (NCT NCT01851655)
NCT ID: NCT01851655
Last Updated: 2014-09-18
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Baseline (pre-intervention) to 9 weeks (post-intervention)
Results posted on
2014-09-18
Participant Flow
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 She was withdrawn prior to randomization. 24 subjects were randomized to the study.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anterior Cruciate Ligament Reconstruction and Plyometric Exercise
Baseline characteristics by cohort
| Measure |
Plyometric Exercise - High Intensity
n=12 Participants
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).
|
Plyometric Exercise - Low Intensity
n=12 Participants
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).
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.3 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
20.7 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
20.0 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention) to 9 weeks (post-intervention)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).
Outcome measures
| Measure |
Plyometric Exercise - High Intensity
n=12 Participants
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).
|
Plyometric Exercise - Low Intensity
n=12 Participants
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).
|
|---|---|---|
|
Change in International Knee Documentation Committee (IKDC) Subjective Form Score.
|
15.5 units on a scale
Standard Deviation 6.8
|
12.1 units on a scale
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention) to 9 weeks (post-intervention)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).
Outcome measures
| Measure |
Plyometric Exercise - High Intensity
n=12 Participants
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).
|
Plyometric Exercise - Low Intensity
n=12 Participants
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).
|
|---|---|---|
|
Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)
|
-0.1 log-scale transformed value of ng/mmol
Standard Deviation 0.2
|
-0.1 log-scale transformed value of ng/mmol
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline (pre-intervention) to 9 weeks (post-intervention)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).
Outcome measures
| Measure |
Plyometric Exercise - High Intensity
n=12 Participants
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).
|
Plyometric Exercise - Low Intensity
n=12 Participants
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).
|
|---|---|---|
|
Change in Vertical Jump Height.
|
5.0 cm
Standard Deviation 4.7
|
2.6 cm
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Baseline (pre-intervention) to 9 weeks (post-intervention)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).
Outcome measures
| Measure |
Plyometric Exercise - High Intensity
n=12 Participants
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).
|
Plyometric Exercise - Low Intensity
n=12 Participants
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).
|
|---|---|---|
|
Change in the Ratio of Urinary CTXII to Serum CPII Concentrations.
|
0.02 log [(ng/mmol)/(ng/mL)]
Standard Deviation 0.06
|
-0.01 log [(ng/mmol)/(ng/mL)]
Standard Deviation 0.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-intervention) to 9 weeks (post-intervention)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)
Outcome measures
| Measure |
Plyometric Exercise - High Intensity
n=12 Participants
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).
|
Plyometric Exercise - Low Intensity
n=12 Participants
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).
|
|---|---|---|
|
Change in Quadriceps Strength
|
0.13 ft-lb/lb
Standard Deviation 0.13
|
0.08 ft-lb/lb
Standard Deviation 0.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-intervention) to 9 weeks (post-intervention)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).
Outcome measures
| Measure |
Plyometric Exercise - High Intensity
n=12 Participants
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).
|
Plyometric Exercise - Low Intensity
n=12 Participants
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).
|
|---|---|---|
|
Change in Fear of Movement/Re-injury
|
0.1 units on a scale
Standard Deviation 4.1
|
-0.2 units on a scale
Standard Deviation 3.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-intervention) to 9 weeks (post-intervention)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).
Outcome measures
| Measure |
Plyometric Exercise - High Intensity
n=12 Participants
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).
|
Plyometric Exercise - Low Intensity
n=12 Participants
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).
|
|---|---|---|
|
Change in Anterior Knee Laxity
|
-0.1 mm
Standard Deviation 0.6
|
-0.2 mm
Standard Deviation 1.5
|
Adverse Events
Plyometric Exercise - High Intensity
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Plyometric Exercise - Low Intensity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Plyometric Exercise - High Intensity
n=12 participants at risk
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).
|
Plyometric Exercise - Low Intensity
n=12 participants at risk
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).
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|---|---|---|
|
Musculoskeletal and connective tissue disorders
Injury
|
8.3%
1/12 • Number of events 1 • Adverse events were compiled as they occurred.
|
0.00%
0/12 • Adverse events were compiled as they occurred.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place