NCT02077413

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

2.7 years

First QC Date

February 27, 2014

Last Update Submit

November 16, 2016

Conditions

Muscle Injury

Keywords

muscleeccentric exerciseT2 MRI

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    Change in baseline to week 1

Secondary Outcomes (12)

  • Change from Baseline in Creatine Kinase levels

    Change in baseline to 48 hours

  • Change from Baseline in Muscle water proton T2

    Change in baseline to 48 hours

  • Change from Baseline in Muscle contractile area

    Change in baseline to 48 hours

  • Change from Baseline in Isometric muscle strength of the ankle dorsiflexors

    Change in baseline to 48 hours

  • Change from Baseline in Pain scores on a visual analog scale

    Change in baseline to 48 hours

  • +7 more secondary outcomes

Study Arms (4)

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.

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.

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.

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.

Procedure: Muscle Atrophy

Interventions

Healthy Muscle GroupPROCEDURE

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.

Healthy Muscle Group
Stretch-Contract Pre-rehabilitation GroupPROCEDURE

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 Pre-rehabilitation Group
Stretch-Contract Control GroupPROCEDURE

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.

Stretch-Contract Control Group
Muscle AtrophyPROCEDURE

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.

Muscle Atrophy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

  • Donovan J Lott, PT, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 4, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

US(1)