Muscle InjuryNCT02077413
Muscle Injury Prevention & Rehabilitation in Military Personnel
A study testing Healthy Muscle Group, Stretch-Contract Pre-rehabilitation Group and Muscle Atrophy in people with Muscle Injury, run by University of Florida at 1 site in United States.
Trial summary
The overall goal of this study is to establish a new pre-rehabilitation program in the prevention of muscle injury in the legs of healthy people serving in the military and injured individuals with muscle wasting following leg injuries. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Injury
- What is being tested?
- Healthy Muscle Group, Stretch-Contract Pre-rehabilitation Group and Muscle Atrophy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 2016
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion criteria for control subjects [primary target being Reserve Officer Training Corps (ROTC) personnel]: 1) healthy individuals ages 18-40 years; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion.
- Exclusion criteria for control subjects (primary target being ROTC personnel): 1) previous history of trauma and/or surgery to the lower extremities that may limit function; 2) neurological, vascular, or cardiac problems that may limit function; 3) diabetes; 4) previous traumatic head injury or post-traumatic stress disorder; 5) a contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible, pregnancy, and severe claustrophobia; and 6) currently performing an exercise program that specifically targets the dorsiflexor muscles.
- Inclusion criteria for subjects with muscle atrophy: 1) individuals ages 18-40 years with an injury to the lower leg requiring immobilization but no surgical intervention; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion.
- Exclusion criteria for subjects with muscle atrophy: 1) previous history of trauma and/or surgery to the lower extremities, other than the injury for being immobilized, that may limit function; 2) neurological, vascular, or cardiac problems that may limit function; 3) orthopedic conditions affecting the contralateral, uninvolved lower extremity that may limit function; 4) diabetes; 5) previous traumatic head injury or post-traumatic stress disorder; and 6) a contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible, pregnancy, and severe claustrophobia.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of this study is to establish a new pre-rehabilitation program in the prevention of muscle injury in the legs of healthy people serving in the military and injured individuals with muscle wasting following leg injuries. The specific goals include: 1) the amount of exercise that causes injury to healthy muscle in the lower leg of healthy people; 2) what is the effect of an intervention (pre-rehabilitation program) on decreasing how easily the muscle of the lower leg can be injured in healthy people; 3a) what amount of exercise causes injury to muscle that has recently been injured and is recovering and 3b) the effect of the new pre-rehabilitation program on the muscles of the lower leg when the muscle has recently been injured and is still recovering.
For the first goal, the investigators will determine how easily the muscle can get injured from a specific exercise in 6 healthy, conditioned men and women. Participants will perform different amounts of exercise with the lower leg muscles to see how easily the muscle can be damaged. Magnetic resonance imaging (MRI) will be used to estimate how much damage occurs with the different levels of exercise. For the second goal, the investigators will examine the effect of a new pre-rehabilitation program on decreasing how easily muscle gets damaged from the exercise we did in the first goal. The investigators will invite healthy people to participate in this goal. The investigators will use MRI, blood markers, and pain as ways of assessing muscle damage in 10 people who do the pre-rehabilitation program before exercising and 10 who do not do the new program. The third goal will focus on a) determining how easily muscle gets injured that has recently recovered from some trauma (5 people will participate in this part of the third goal), and b) determining how a pre-rehabilitation program decreases how easily a muscle that has just recovered from trauma gets injured from exercise (10 people will participate in this part of the third goal).
Read the detailed description
A total of 26 healthy adults and 15 adults who have recently experienced muscle atrophy from conservative treatment after an orthopedic lower leg/ankle/foot injury that did not require surgery but did require immobilization will participate.
Magnetic resonance imaging (MRI) will be used to estimate how much damage occurs with the different levels of exercise. The investigators will be using a T2 MR which has been shown to be sensitive to injury of muscle damage.
There will be four groups in this protocol as outlined:
Healthy Muscle Group:
Six subjects will be enrolled in this group. MRI measures will be performed at baseline and 48 hours post-exercise, when the largest amount of muscle damage is typically observed. They will be tested for maximum strength of the dorsiflexors and then undergo an eccentric exercise protocol for both lower legs on the Biodex with varying loads. Approximately two days after the exercise protocol, the participants will have another MRI of the lower legs to assess any change in T2 relaxation time as a construct of muscle edema/damage.
Stretch-Contract Pre-rehabilitation Group All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. They will also receive the "stretch-contract" protocol on one leg consisting of the following: a 5 second passive stretch of the dorsiflexors, followed immediately by a 5 second active isometric contraction of the dorsiflexors, and a 5 second rest/relaxation period. This cycle will continue for a duration of ~5 minutes.
Stretch-Contract Control Group All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. This group will not receive the "stretch-contract" protocol.
Muscle Atrophy These subjects will undergo MRI and strength testing at baseline and will also be assessed for CK levels, pain report, and ROM. They will then receive an eccentric loading paradigm for the dorsiflexor muscles of the involved leg using an isokinetic dynamometer with varying loads.
All exercise testing will be performed on an isokinetic dynamometer by a physical therapist who has received extensive training for this piece of exercise equipment.
- Conditions
- Muscle Injury
- Being tested
- Healthy Muscle Group, Stretch-Contract Pre-rehabilitation Group, Stretch-Contract Control Group, Muscle Atrophy
- Keywords
- muscle, eccentric exercise, T2 MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Muscle GroupProcedure or surgery
Six subjects will be enrolled in this group. MRI measures will be performed at baseline and 48 hours post-exercise, when the largest amount of muscle damage is typically observed. They will be tested for maximum strength of the dorsiflexors and then undergo an eccentric exercise protocol for both lower legs on the Biodex with varying loads. Approximately two days after the exercise protocol, the participants will have another MRI of the lower legs to assess any change in T2 relaxation time as a construct of muscle edema/damage.
Stretch-Contract Pre-rehabilitation GroupProcedure or surgery
All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. They will also receive the "stretch-contract" protocol on one leg consisting of the following: a 5 second passive stretch of the dorsiflexors, followed immediately by a 5 second active isometric contraction of the dorsiflexors, and a 5 second rest/relaxation period. This cycle will continue for a duration of ~5 minutes.
Stretch-Contract Control GroupProcedure or surgery
All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors.
Muscle AtrophyProcedure or surgery
These subjects will undergo MRI and strength testing at baseline and will also be assessed for CK levels, pain report, and ROM. They will then receive an eccentric loading paradigm for the dorsiflexor muscles of the involved leg using an isokinetic dynamometer with varying loads. Approximately two days after the exercise protocol, follow-up assessment of MRI, CK levels, pain report, ROM, and strength will be done.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Muscle Group | Active comparator | Six subjects will be enrolled in this group. MRI measures will be performed at baseline and 48 hours post-exercise, when the largest amount of muscle damage is typically observed. They will be tested for maximum strength of the dorsiflexors and then undergo an eccentric exercise protocol for both lower legs on the Biodex with varying loads. Approximately two days after the exercise protocol, the participants will have another MRI of the lower legs to assess any change in T2 relaxation time as a construct of muscle edema/damage. Receives: Procedure: Healthy Muscle Group |
| Stretch-Contract Pre-rehabilitation Group | Experimental | All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. They will also receive the "stretch-contract" protocol on one leg consisting of the following: a 5 second passive stretch of the dorsiflexors, followed immediately by a 5 second active isometric contraction of the dorsiflexors, and a 5 second rest/relaxation period. This cycle will continue for a duration of ~5 minutes. Receives: Procedure: Stretch-Contract Pre-rehabilitation Group |
| Stretch-Contract Control Group | Active comparator | All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. Receives: Procedure: Stretch-Contract Control Group |
| Muscle Atrophy | Experimental | These subjects will undergo MRI and strength testing at baseline and will also be assessed for CK levels, pain report, and ROM. They will then receive an eccentric loading paradigm for the dorsiflexor muscles of the involved leg using an isokinetic dynamometer with varying loads. Approximately two days after the exercise protocol, follow-up assessment of MRI, CK levels, pain report, ROM, and strength will be done. Receives: Procedure: Muscle Atrophy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in T2 relaxation time of skeletal muscle in the lower leg
T2 weighted spin-echo magnetic resonance imaging (MRI) will be acquired with a fixed bandwidth, a TR=3s, optimized field of view (FOV_, 7mm slice thickness, and TEs of 20, 40, 60, 80, and 100 msec. A pixel-by-pixel T2 map will be created for each slice by fitting the decay in image signal intensity (SI) to a single exponential (SI=Aexp-TE/T2+B; A=proton density) with respect to echo time (TE).
Measured: Change in baseline to 48 hours
Change from Baseline in T2 relaxation time of skeletal muscle in the lower leg
T2 weighted spin-echo magnetic resonance imaging (MRI) will be acquired with a fixed bandwidth, a TR=3s, optimized field of view (FOV_, 7mm slice thickness, and TEs of 20, 40, 60, 80, and 100 msec. A pixel-by-pixel T2 map will be created for each slice by fitting the decay in image signal intensity (SI) to a single exponential (SI=Aexp-TE/T2+B; A=proton density) with respect to echo time (TE).
Measured: Change in baseline to week 1
Secondary outcomes (12)
Change from Baseline in Creatine Kinase levels
Approximately 10 ml of blood will be analyzed for CK levels.
Measured: Change in baseline to 48 hours
Change from Baseline in Muscle water proton T2
A spectroscopic relaxometry sequence may be implemented to quantify changes in muscle water proton (1H2O) T2. Sixteen echoes may be acquired in the musculature of the lower leg under fully relaxed conditions (TR=9 s). This sequence will allow for both the determination of global T2 as well as multiexponential fitting of the T2 decay using non-negative least squares analysis.
Measured: Change in baseline to 48 hours
Change from Baseline in Muscle contractile area
A T1 weighted MRI will be used to measure changes in muscle contractile area. Using a coronal localizer scout, transaxial images (~50 slices) will be acquired along the length of the muscles, oriented perpendicular to the long bone (tibia or femur). All images may be acquired with optimized FOV(~12x12 cm2), TR=17 ms, TE=2ms, Number of Excitations (NEX)=2, and a flip angle of 20˚. Images may be acquired with an encoding matrix of 256x256 and 3mm slice thickness.
Measured: Change in baseline to 48 hours
Change from Baseline in Isometric muscle strength of the ankle dorsiflexors
Ankle dorsiflexor muscles will be tested using an isokinetic dynamometer. The measurement of the peak isometric torque will be taken with the subjects seated in an upright position using a standardized set-up. Assessment of the dorsiflexors will be performed with the ankle in slight plantarflexion and the knee in slight flexion. The subjects will have three to ten maximal trials of ~5 sec which will be performed and the peak torque recorded. A rest time of ~1 minute will be provided between each contraction. A visual feedback display will be used to motivate the subjects to reach their maximum torque output. Peak torque measures may be normalized to maximal cross-sectional area (CSAmax) to assess muscle specific torque.
Measured: Change in baseline to 48 hours
Change from Baseline in Pain scores on a visual analog scale
Subjects who participate in pain assessment will be asked to rate any pain they are experiencing at the time of assessment using a numeric rating scale of a line anchored at 0 (no pain sensation at all) and 100 (worst pain imaginable). Subjects will be asked to rate any pain by making a mark on the 100 mm line.
Measured: Change in baseline to 48 hours
Change from Baseline in ankle Range of Motion (ROM)
Subjects who participate in ROM testing will be positioned supine with their knee fully extended, and ankle ROM for both dorsiflexion and plantarflexion will be determined actively with a standard goniometer.
Measured: Change in baseline to 48 hours
Change from Baseline in Creatine Kinase levels
Approximately 10 ml of blood will be analyzed for CK levels.
Measured: Change in baseline to week 1
Change from Baseline in Muscle water proton T2
A spectroscopic relaxometry sequence may be implemented to quantify changes in muscle water proton (1H2O) T2. Sixteen echoes may be acquired in the musculature of the lower leg under fully relaxed conditions (TR=9 s). This sequence will allow for both the determination of global T2 as well as multiexponential fitting of the T2 decay using non-negative least squares analysis.
Measured: Change in baseline to week 1
Change from Baseline in Muscle contractile area
A T1 weighted MRI will be used to measure changes in muscle contractile area. Using a coronal localizer scout, transaxial images (~50 slices) will be acquired along the length of the muscles, oriented perpendicular to the long bone (tibia or femur). All images may be acquired with optimized FOV(~12x12 cm2), TR=17 ms, TE=2ms, Number of Excitations (NEX)=2, and a flip angle of 20˚. Images may be acquired with an encoding matrix of 256x256 and 3mm slice thickness.
Measured: Change in baseline to week 1
Change from Baseline in Isometric muscle strength of the ankle dorsiflexors
Ankle dorsiflexor muscles will be tested using an isokinetic dynamometer. The measurement of the peak isometric torque will be taken with the subjects seated in an upright position using a standardized set-up. Assessment of the dorsiflexors will be performed with the ankle in slight plantarflexion and the knee in slight flexion. The subjects will have three to ten maximal trials of ~5 sec which will be performed and the peak torque recorded. A rest time of ~1 minute will be provided between each contraction. A visual feedback display will be used to motivate the subjects to reach their maximum torque output. Peak torque measures may be normalized to maximal cross-sectional area (CSAmax) to assess muscle specific torque.
Measured: Change in baseline to week 1
Change from Baseline in Pain scores on a visual analog scale
Subjects who participate in pain assessment will be asked to rate any pain they are experiencing at the time of assessment using a numeric rating scale of a line anchored at 0 (no pain sensation at all) and 100 (worst pain imaginable). Subjects will be asked to rate any pain by making a mark on the 100 mm line.
Measured: Change in baseline to week 1
Change from Baseline in ankle Range of Motion (ROM)
Subjects who participate in ROM testing will be positioned supine with their knee fully extended, and ankle ROM for both dorsiflexion and plantarflexion will be determined actively with a standard goniometer.
Measured: Change in baseline to week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donovan J Lott, PT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077413
- Sponsor's protocol ID
- USAMRMC W81XH-11-1-0454
- Status last verified
- Nov 2016
- First submitted
- 27 Feb 2014
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Injury Prevention & Rehabilitation in Military Personnel
- ClinicalTrials.gov ID
- NCT02077413
- Acronym / sponsor ID
- USAMRMC W81XH-11-1-0454
- Conditions
- Muscle Injury
- Keywords
- muscle, eccentric exercise, T2 MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Mar 2014 (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.
The overall goal of this study is to establish a new pre-rehabilitation program in the prevention of muscle injury in the legs of healthy people serving in the military and injured individuals with muscle wasting following leg injuries. The specific goals include: 1) the amount of exercise that causes injury to healthy muscle in the lower leg of healthy people; 2) what is the effect of an intervention (pre-rehabilitation program) on decreasing how easily the muscle of the lower leg can be injured in healthy people; 3a) what amount of exercise causes injury to muscle that has recently been injured and is recovering and 3b) the effect of the new pre-rehabilitation program on the muscles of the lower leg when the muscle has recently been injured and is still recovering.
For the first goal, the investigators will determine how easily the muscle can get injured from a specific exercise in 6 healthy, conditioned men and women. Participants will perform different amounts of exercise with the lower leg muscles to see how easily the muscle can be damaged. Magnetic resonance imaging (MRI) will be used to estimate how much damage occurs with the different levels of exercise. For the second goal, the investigators will examine the effect of a new pre-rehabilitation program on decreasing how easily muscle gets damaged from the exercise we did in the first goal. The investigators will invite healthy people to participate in this goal. The investigators will use MRI, blood markers, and pain as ways of assessing muscle damage in 10 people who do the pre-rehabilitation program before exercising and 10 who do not do the new program. The third goal will focus on a) determining how easily muscle gets injured that has recently recovered from some trauma (5 people will participate in this part of the third goal), and b) determining how a pre-rehabilitation program decreases how easily a muscle that has just recovered from trauma gets injured from exercise (10 people will participate in this part of the third goal).
Detailed description
A total of 26 healthy adults and 15 adults who have recently experienced muscle atrophy from conservative treatment after an orthopedic lower leg/ankle/foot injury that did not require surgery but did require immobilization will participate.
Magnetic resonance imaging (MRI) will be used to estimate how much damage occurs with the different levels of exercise. The investigators will be using a T2 MR which has been shown to be sensitive to injury of muscle damage.
There will be four groups in this protocol as outlined:
Healthy Muscle Group:
Six subjects will be enrolled in this group. MRI measures will be performed at baseline and 48 hours post-exercise, when the largest amount of muscle damage is typically observed. They will be tested for maximum strength of the dorsiflexors and then undergo an eccentric exercise protocol for both lower legs on the Biodex with varying loads. Approximately two days after the exercise protocol, the participants will have another MRI of the lower legs to assess any change in T2 relaxation time as a construct of muscle edema/damage.
Stretch-Contract Pre-rehabilitation Group All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. They will also receive the "stretch-contract" protocol on one leg consisting of the following: a 5 second passive stretch of the dorsiflexors, followed immediately by a 5 second active isometric contraction of the dorsiflexors, and a 5 second rest/relaxation period. This cycle will continue for a duration of ~5 minutes.
Stretch-Contract Control Group All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. This group will not receive the "stretch-contract" protocol.
Muscle Atrophy These subjects will undergo MRI and strength testing at baseline and will also be assessed for CK levels, pain report, and ROM. They will then receive an eccentric loading paradigm for the dorsiflexor muscles of the involved leg using an isokinetic dynamometer with varying loads.
All exercise testing will be performed on an isokinetic dynamometer by a physical therapist who has received extensive training for this piece of exercise equipment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Muscle Group | Active comparator | Procedure: Healthy Muscle GroupSix subjects will be enrolled in this group. MRI measures will be performed at baseline and 48 hours post-exercise, when the largest amount of muscle damage is typically observed. They will be tested for maximum strength of the dorsiflexors and then undergo an eccentric exercise protocol for both lower legs on the Biodex with varying loads. Approximately two days after the exercise protocol, the participants will have another MRI of the lower legs to assess any change in T2 relaxation time as a construct of muscle edema/damage. |
| Stretch-Contract Pre-rehabilitation Group | Experimental | Procedure: Stretch-Contract Pre-rehabilitation GroupAll subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. They will also receive the "stretch-contract" protocol on one leg consisting of the following: a 5 second passive stretch of the dorsiflexors, followed immediately by a 5 second active isometric contraction of the dorsiflexors, and a 5 second rest/relaxation period. This cycle will continue for a duration of ~5 minutes. |
| Stretch-Contract Control Group | Active comparator | Procedure: Stretch-Contract Control GroupAll subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. |
| Muscle Atrophy | Experimental | Procedure: Muscle AtrophyThese subjects will undergo MRI and strength testing at baseline and will also be assessed for CK levels, pain report, and ROM. They will then receive an eccentric loading paradigm for the dorsiflexor muscles of the involved leg using an isokinetic dynamometer with varying loads. Approximately two days after the exercise protocol, follow-up assessment of MRI, CK levels, pain report, ROM, and strength will be done. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Inclusion criteria for control subjects [primary target being Reserve Officer Training Corps (ROTC) personnel]: 1) healthy individuals ages 18-40 years; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion.
- Exclusion criteria for control subjects (primary target being ROTC personnel): 1) previous history of trauma and/or surgery to the lower extremities that may limit function; 2) neurological, vascular, or cardiac problems that may limit function; 3) diabetes; 4) previous traumatic head injury or post-traumatic stress disorder; 5) a contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible, pregnancy, and severe claustrophobia; and 6) currently performing an exercise program that specifically targets the dorsiflexor muscles.
- Inclusion criteria for subjects with muscle atrophy: 1) individuals ages 18-40 years with an injury to the lower leg requiring immobilization but no surgical intervention; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion.
- Exclusion criteria for subjects with muscle atrophy: 1) previous history of trauma and/or surgery to the lower extremities, other than the injury for being immobilized, that may limit function; 2) neurological, vascular, or cardiac problems that may limit function; 3) orthopedic conditions affecting the contralateral, uninvolved lower extremity that may limit function; 4) diabetes; 5) previous traumatic head injury or post-traumatic stress disorder; and 6) a contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible, pregnancy, and severe claustrophobia.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Healthy Muscle GroupSix subjects will be enrolled in this group. MRI measures will be performed at baseline and 48 hours post-exercise, when the largest amount of muscle damage is typically observed. They will be tested for maximum strength of the dorsiflexors and then undergo an eccentric exercise protocol for both lower legs on the Biodex with varying loads. Approximately two days after the exercise protocol, the participants will have another MRI of the lower legs to assess any change in T2 relaxation time as a construct of muscle edema/damage. | Procedure or surgery | Healthy Muscle Group |
| Stretch-Contract Pre-rehabilitation GroupAll subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. They will also receive the "stretch-contract" protocol on one leg consisting of the following: a 5 second passive stretch of the dorsiflexors, followed immediately by a 5 second active isometric contraction of the dorsiflexors, and a 5 second rest/relaxation period. This cycle will continue for a duration of ~5 minutes. | Procedure or surgery | Stretch-Contract Pre-rehabilitation Group |
| Stretch-Contract Control GroupAll subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. | Procedure or surgery | Stretch-Contract Control Group |
| Muscle AtrophyThese subjects will undergo MRI and strength testing at baseline and will also be assessed for CK levels, pain report, and ROM. They will then receive an eccentric loading paradigm for the dorsiflexor muscles of the involved leg using an isokinetic dynamometer with varying loads. Approximately two days after the exercise protocol, follow-up assessment of MRI, CK levels, pain report, ROM, and strength will be done. | Procedure or surgery | Muscle Atrophy |
Primary outcome
Change from Baseline in T2 relaxation time of skeletal muscle in the lower leg
Time frame: Change in baseline to 48 hours
T2 weighted spin-echo magnetic resonance imaging (MRI) will be acquired with a fixed bandwidth, a TR=3s, optimized field of view (FOV_, 7mm slice thickness, and TEs of 20, 40, 60, 80, and 100 msec. A pixel-by-pixel T2 map will be created for each slice by fitting the decay in image signal intensity (SI) to a single exponential (SI=Aexp-TE/T2+B; A=proton density) with respect to echo time (TE).
Change from Baseline in T2 relaxation time of skeletal muscle in the lower leg
Time frame: Change in baseline to week 1
T2 weighted spin-echo magnetic resonance imaging (MRI) will be acquired with a fixed bandwidth, a TR=3s, optimized field of view (FOV_, 7mm slice thickness, and TEs of 20, 40, 60, 80, and 100 msec. A pixel-by-pixel T2 map will be created for each slice by fitting the decay in image signal intensity (SI) to a single exponential (SI=Aexp-TE/T2+B; A=proton density) with respect to echo time (TE).
12 secondary outcomes
Change from Baseline in Creatine Kinase levels
Time frame: Change in baseline to 48 hours
Change from Baseline in Muscle water proton T2
Time frame: Change in baseline to 48 hours
Change from Baseline in Muscle contractile area
Time frame: Change in baseline to 48 hours
Change from Baseline in Isometric muscle strength of the ankle dorsiflexors
Time frame: Change in baseline to 48 hours
Change from Baseline in Pain scores on a visual analog scale
Time frame: Change in baseline to 48 hours
Change from Baseline in ankle Range of Motion (ROM)
Time frame: Change in baseline to 48 hours
Change from Baseline in Creatine Kinase levels
Time frame: Change in baseline to week 1
Change from Baseline in Muscle water proton T2
Time frame: Change in baseline to week 1
Change from Baseline in Muscle contractile area
Time frame: Change in baseline to week 1
Change from Baseline in Isometric muscle strength of the ankle dorsiflexors
Time frame: Change in baseline to week 1
Change from Baseline in Pain scores on a visual analog scale
Time frame: Change in baseline to week 1
Change from Baseline in ankle Range of Motion (ROM)
Time frame: Change in baseline to week 1
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 17 Nov 2016.
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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.
Donovan J Lott, PT, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Muscle Group, Stretch-Contract Pre-rehabilitation Group and Muscle Atrophy in people with Muscle Injury, run by University of Florida at 1 site 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 0 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 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 from Baseline in T2 relaxation time of skeletal muscle in the lower leg (time frame: Change in baseline to 48 hours). The study lists 2 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 17 Nov 2016.