Duchenne Muscular DystrophyNCT02421523
Strength Training in Duchenne Muscular Dystrophy
A study testing Aim 2 Exercise group and Aim 1 Exercise Dosing in people with Duchenne Muscular Dystrophy, run by University of Florida at 1 site in United States.
Trial summary
Duchenne muscular dystrophy (DMD) is a debilitating neuromuscular disease that causes muscle breakdown, weakness, and eventual death. Over the last 40 years parents have received little guidance on the potential of exercise as a therapeutic strategy to maintain muscle function. Read more about this study
- Who is it for?
- Ages 7 to 10 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Aim 2 Exercise group and Aim 1 Exercise Dosing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2015to 8 Oct 2018
- 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 7 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of DMD confirmed by
- clinical history with features before the age of five
- physical examination
- elevated serum creatine kinase level
- absence of dystrophin expression, as determined by immunostain or Western blot (<2%) and/or DNA confirmation of dystrophin mutation.
- Age 7 to 10.5 years: a lower age limit of 7 years was selected, since in our experience children younger than 7 years are likely unable to cooperate and comply with all of the exercise measures as needed. An upper age limit of 10.5 years has been set as boys with DMD tend to reach a rapid progression into a late ambulatory phase soon after this age.
- Ambulatory at the time of the first visit, defined as the ability to walk for at least 100 m without an external assistive device and able to climb four stairs.
- Currently using corticosteroids (prednisone or deflazacort) as prescribed by a physician.
Who cannot join
- Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants)
- Presence of a condition in control subjects or a secondary condition in boys with DMD that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
- Secondary condition leading to developmental delay or impaired motor control (e.g. cerebral palsy)
- Secondary condition that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
- Unstable medical condition (e.g. uncontrolled seizure disorder)
- Behavioral problems causing an inability to cooperate during testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Strength Training Protocol in Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a debilitating neuromuscular disease that causes muscle breakdown, weakness, and eventual death. Over the last 40 years parents have received little guidance on the potential of exercise as a therapeutic strategy to maintain muscle function. It is well known that high intensity exercise and eccentric contractions can result in muscle damage in dystrophic muscle, yet the absence of muscle loading will conversely result in muscle wasting. Recent research in rodent models and milder forms of muscular dystrophy supports earlier studies that resistance exercise may have beneficial effects for maintenance of muscle mass in dystrophic muscle. However, careful and systematic investigation into the safety and feasibility of resistance exercise is needed to consider its implementation in boys with DMD.
The goal of this project is to assess the safety and feasibility of a home based mild to moderate-intensity strengthening exercise program in boys with Duchenne muscular dystrophy (DMD). Evidence from milder forms of muscular dystrophy and mouse models of DMD suggests that strengthening exercise may be beneficial for these children, but this area has not been adequately explored using human subjects. The results of this study should provide information to assist in the development of scientifically based recommendations concerning optimal exercise parameters for patients with DMD.
Read the detailed description
The overall objective of this pilot study is to assess whether a mild to moderate-intensity strengthening exercise program can be safely implemented in boys with DMD. In Aim 1, the investigators will determine the dose response and safety of mild to moderate-intensity isometric resistance exercise in children with DMD. Twelve ambulatory boys with DMD will participate in an isometric exercise dosing protocol, in which the load is progressively increased. In this early proof of concept pilot study, two large muscle groups will be studied: the knee extensors and the knee flexors. T2 weighted magnetic resonance imaging (MRI) of the thigh muscles will be used to monitor evidence of muscle damage at each intensity level and determine a safe exercise range. Other safety measures will include a verbal pain rating scale, clinical examination, and serum creatine kinase (CK) levels. In Aim 2, the investigators will implement a pilot intervention study to examine the feasibility and safety of a 12 week in-home isometric strengthening program in children with DMD. In this study, 20 boys with DMD will be randomized to either an exercise group or a control group. Ten boys with DMD randomized to the exercise group will complete a progressive exercise program using the parameters and dose identified in Aim 1. Assessment of strength and safety will be performed at regular time intervals throughout the study. Ten boys with DMD randomized to not participate in an exercise intervention will be tested at similar time intervals and serve as controls. The data from this pilot study will serve to perform the power analysis needed to design an appropriately powered clinical intervention study.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Aim 2 Exercise group, Aim 1 Exercise Dosing, Aim 2 Control group
- Keywords
- Exercise, Strength training
- Medical subject headings
- Muscular Dystrophy, Duchenne, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aim 2 Exercise groupProcedure or surgery
The experimental group will participate in an isometric exercise strengthening intervention with a frequency of ~three times/week for 12 weeks. Training will include using a custom-built exercise set-up and a live monitoring system for all of the subjects who participate in the experimental group. Progression of the exercise program will only occur after safety assessments at weeks 3, 6, and 9. The safety assessments to occur at baseline, 1 week, 6 weeks, and 12 weeks include T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels. The safety assessments to occur at 3 weeks and 9 weeks include the pain rating scale and CK levels. Participants in this group may also be tested for strength assessments (of the knee flexors and extensors) and time to climb 4 stairs.
Aim 1 Exercise DosingProcedure or surgery
The maximal voluntary contraction (MVC) will be determined for each subject. The first four subjects will exercise at an intensity of ~30% of the subject's MVC. Subjects will be asked to perform ~4 sets of 6 reps of knee extension and knee flexion contractions. 48hs after the exercise is completed a safety assessment will be performed for muscle damage. If none has occurred, four additional subjects will perform the exercise at the next level of intensity (~50% MVC). Similarly, if no damage has occurred at ~50% MVC, four more subjects exercise at ~70% MVC. All safety measures will be performed 48hrs after the exercise has been completed at each of the levels. These safety assessments include T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels.
Aim 2 Control groupProcedure or surgery
This group will receive safety assessments at baseline, 1 week, 6 weeks, and 12 weeks including T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels. They will also receive safety assessments at 3 weeks and 9 weeks that will include the pain rating scale and CK levels. Participants in this group may also be tested for strength assessments (of the knee flexors and extensors) and time to climb 4 stairs.
| Study group | Role | What they receive |
|---|---|---|
| Aim 2 Exercise group | Experimental | The 10 subjects randomized to the experimental group will participate in an isometric exercise strengthening intervention of the knee extensor and knee flexor muscles in both legs with a frequency of ~three times/week for 12 weeks. Receives: Procedure: Aim 2 Exercise group |
| Aim 2 Control group | Active comparator | The 10 subjects randomized to the control group will not participate in any exercise program during the 12 weeks and will be instructed to continue with their normal activities. Receives: Procedure: Aim 2 Control group |
| Aim 1 Exercise Dosing | Experimental | In order to implement a pilot home exercise intervention, the dose response and safety of this intervention must first be determined. We will enroll 12 boys with DMD for this aim and testing will be performed on the right leg. Receives: Procedure: Aim 1 Exercise Dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in T2 weighted MRI of skeletal muscle in leg for Aim 2
In order to examine the distribution of affected tissue (versus unaffected tissue) across the lower extremity muscles, multi-slice spin-echo images will be acquired from the lower leg and thigh muscles. A pixel-by-pixel T2 map will be created for each slice (minimal 8 slices) 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). The total affected tissue volume (% of pixels with T2 >2SD above control) will be recorded for each of the lower extremity muscles. Subsequently, the same T2 weighted spin-echo sequence will be implemented with fat suppression (FS) and T2 FS maps are created. Based on the difference in proton density between the two spin-echo sequences the T2 FS pixels primarily composed of lipid will be eliminated, and the muscle lesion volume (% of unsuppressed pixels with elevated T2 values) will be recorded for each of the lower extremity muscles.
Measured: Change in baseline relative to 1 week, 6 weeks, 12 weeks
Change in base line in T2 weighted MRI of skeletal muscle in leg for Aim 1
Magnetic resonance imaging will be performed with a Philips 3.0T whole body scanner. Subjects will be positioned supine in the magnet. Multi-slice (6 axial slices) multi-echo (16 echoes with equal spacing from 20-320 ms) T2-weighted imaging will be performed on the upper leg (thigh). T2 maps of the thigh muscles will be created and mean T2 values of the knee extensor muscle group and flexor muscle group will be measured as well as the proportion of pixels defined as elevated (>2SD).
Measured: Change in baseline relative to 48 hours after exercise
Secondary outcomes (6)
Change from baseline in Spectroscopic Relaxometry for Aim 2
A spectroscopic relaxometry sequence may be implemented to quantify changes in muscle 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 relative to 1 week, 6 weeks, 12 weeks
Change from baseline in Spectroscopic Relaxometry for Aim 1
A spectroscopic relaxometry sequence may be implemented to quantify changes in muscle 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 relative to 48 hours after exercise
Change from baseline in Creatine Kinase (CK) Levels for Aim 2
Blood collection for the baseline, 6 wk, and 12 wks time points will take place at the Clinical Research Center (CRC) at the University of Florida (UF). Blood samples needed for the 3 and 9wk safety assessments may be done within the subjects' local community as we have done previously (Smith 2013). Specifically, we may have the subjects go to a local laboratory for these blood draws to be done by a nurse or physician. Approximately 10 ml of blood will be collected from the antecubital vein while the subject is seated. The analysis for CK levels will take place at Shands Medical Laboratories, and their staff will perform analyses as per their standardized procedures. Following analysis, Shands Medical Laboratories will keep the labeled blood refrigerated at ~5 degrees C for one week, after which time the blood will be incinerated.
Measured: Change in baseline relative to 1 week, 3 weeks, 6 weeks, 9 weeks, 12 weeks
Change from baseline in Creatine Kinase (CK) Levels for Aim 1
Blood collection for the baseline and 48 hours after exercise will take place at the Clinical Research Center (CRC) at UF. Approximately 10 ml of blood will be collected from the antecubital vein while the subject is seated. The analysis for CK levels will take place at Shands Medical Laboratories, and their staff will perform analyses as per their standardized procedures. Following analysis, Shands Medical Laboratories will keep the labeled blood refrigerated at ~5 degrees C for one week, after which time the blood will be incinerated.
Measured: Change in baseline relative to 48 hours after exercise
Change from baseline in Pain for Aim 2
Subjects will be asked to rate any pain they are experiencing at the time of assessment using a Wong-Baker FACES Pain Rating Scale with faces and corresponding numbers ranging from 0 (No Hurt) to 10 (Hurts Worst). Subjects will be asked to rate any pain by selecting one of the faces with its corresponding numerical rating and pain description.
Measured: Change in baseline relative to 1 week, 3 weeks, 6 weeks, 9 weeks, 12 weeks
Change from baseline in Pain for Aim 1
Subjects will be asked to rate any pain they are experiencing at the time of assessment using a Wong-Baker FACES Pain Rating Scale with faces and corresponding numbers ranging from 0 (No Hurt) to 10 (Hurts Worst). Subjects will be asked to rate any pain by selecting one of the faces with its corresponding numerical rating and pain description.
Measured: Change in baseline relative to 48 hours after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study start30 May 2015
- Primary completion15 Feb 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Donovan J Lott, PhD, PT, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421523
- Sponsor's protocol ID
- IRB201400874-N
- Other IDs
- 1R21AR064949-01A1
- Status last verified
- Mar 2019
- First submitted
- 15 Apr 2015
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Strength Training Protocol in Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT02421523
- Acronym / sponsor ID
- IRB201400874-N
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Exercise, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 30 May 2015 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 20 Apr 2015 (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.
Duchenne muscular dystrophy (DMD) is a debilitating neuromuscular disease that causes muscle breakdown, weakness, and eventual death. Over the last 40 years parents have received little guidance on the potential of exercise as a therapeutic strategy to maintain muscle function. It is well known that high intensity exercise and eccentric contractions can result in muscle damage in dystrophic muscle, yet the absence of muscle loading will conversely result in muscle wasting. Recent research in rodent models and milder forms of muscular dystrophy supports earlier studies that resistance exercise may have beneficial effects for maintenance of muscle mass in dystrophic muscle. However, careful and systematic investigation into the safety and feasibility of resistance exercise is needed to consider its implementation in boys with DMD.
The goal of this project is to assess the safety and feasibility of a home based mild to moderate-intensity strengthening exercise program in boys with Duchenne muscular dystrophy (DMD). Evidence from milder forms of muscular dystrophy and mouse models of DMD suggests that strengthening exercise may be beneficial for these children, but this area has not been adequately explored using human subjects. The results of this study should provide information to assist in the development of scientifically based recommendations concerning optimal exercise parameters for patients with DMD.
Detailed description
The overall objective of this pilot study is to assess whether a mild to moderate-intensity strengthening exercise program can be safely implemented in boys with DMD. In Aim 1, the investigators will determine the dose response and safety of mild to moderate-intensity isometric resistance exercise in children with DMD. Twelve ambulatory boys with DMD will participate in an isometric exercise dosing protocol, in which the load is progressively increased. In this early proof of concept pilot study, two large muscle groups will be studied: the knee extensors and the knee flexors. T2 weighted magnetic resonance imaging (MRI) of the thigh muscles will be used to monitor evidence of muscle damage at each intensity level and determine a safe exercise range. Other safety measures will include a verbal pain rating scale, clinical examination, and serum creatine kinase (CK) levels. In Aim 2, the investigators will implement a pilot intervention study to examine the feasibility and safety of a 12 week in-home isometric strengthening program in children with DMD. In this study, 20 boys with DMD will be randomized to either an exercise group or a control group. Ten boys with DMD randomized to the exercise group will complete a progressive exercise program using the parameters and dose identified in Aim 1. Assessment of strength and safety will be performed at regular time intervals throughout the study. Ten boys with DMD randomized to not participate in an exercise intervention will be tested at similar time intervals and serve as controls. The data from this pilot study will serve to perform the power analysis needed to design an appropriately powered clinical intervention study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 2 Exercise group | Experimental | Procedure: Aim 2 Exercise groupThe 10 subjects randomized to the experimental group will participate in an isometric exercise strengthening intervention of the knee extensor and knee flexor muscles in both legs with a frequency of ~three times/week for 12 weeks. |
| Aim 2 Control group | Active comparator | Procedure: Aim 2 Control groupThe 10 subjects randomized to the control group will not participate in any exercise program during the 12 weeks and will be instructed to continue with their normal activities. |
| Aim 1 Exercise Dosing | Experimental | Procedure: Aim 1 Exercise DosingIn order to implement a pilot home exercise intervention, the dose response and safety of this intervention must first be determined. We will enroll 12 boys with DMD for this aim and testing will be performed on the right leg. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Diagnosis of DMD confirmed by
- Age 7 to 10.5 years: a lower age limit of 7 years was selected, since in our experience children younger than 7 years are likely unable to cooperate and comply with all of the exercise measures as needed. An upper age limit of 10.5 years has been set as boys with DMD tend to reach a rapid progression into a late ambulatory phase soon after this age.
- Ambulatory at the time of the first visit, defined as the ability to walk for at least 100 m without an external assistive device and able to climb four stairs.
- Currently using corticosteroids (prednisone or deflazacort) as prescribed by a physician.
Key exclusion criteria (6 listed)
- Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants)
- Presence of a condition in control subjects or a secondary condition in boys with DMD that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
- Secondary condition leading to developmental delay or impaired motor control (e.g. cerebral palsy)
- Secondary condition that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
- Unstable medical condition (e.g. uncontrolled seizure disorder)
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 |
|---|---|---|
| Aim 2 Exercise groupThe experimental group will participate in an isometric exercise strengthening intervention with a frequency of ~three times/week for 12 weeks. Training will include using a custom-built exercise set-up and a live monitoring system for all of the subjects who participate in the experimental group. Progression of the exercise program will only occur after safety assessments at weeks 3, 6, and 9. The safety assessments to occur at baseline, 1 week, 6 weeks, and 12 weeks include T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels. The safety assessments to occur at 3 weeks and 9 weeks include the pain rating scale and CK levels. Participants in this group may also be tested for strength assessments (of the knee flexors and extensors) and time to climb 4 stairs. | Procedure or surgery | Aim 2 Exercise group |
| Aim 1 Exercise DosingThe maximal voluntary contraction (MVC) will be determined for each subject. The first four subjects will exercise at an intensity of ~30% of the subject's MVC. Subjects will be asked to perform ~4 sets of 6 reps of knee extension and knee flexion contractions. 48hs after the exercise is completed a safety assessment will be performed for muscle damage. If none has occurred, four additional subjects will perform the exercise at the next level of intensity (~50% MVC). Similarly, if no damage has occurred at ~50% MVC, four more subjects exercise at ~70% MVC. All safety measures will be performed 48hrs after the exercise has been completed at each of the levels. These safety assessments include T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels. | Procedure or surgery | Aim 1 Exercise Dosing |
| Aim 2 Control groupThis group will receive safety assessments at baseline, 1 week, 6 weeks, and 12 weeks including T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels. They will also receive safety assessments at 3 weeks and 9 weeks that will include the pain rating scale and CK levels. Participants in this group may also be tested for strength assessments (of the knee flexors and extensors) and time to climb 4 stairs. | Procedure or surgery | Aim 2 Control group |
Primary outcome
Change from baseline in T2 weighted MRI of skeletal muscle in leg for Aim 2
Time frame: Change in baseline relative to 1 week, 6 weeks, 12 weeks
In order to examine the distribution of affected tissue (versus unaffected tissue) across the lower extremity muscles, multi-slice spin-echo images will be acquired from the lower leg and thigh muscles. A pixel-by-pixel T2 map will be created for each slice (minimal 8 slices) 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). The total affected tissue volume (% of pixels with T2 >2SD above control) will be recorded for each of the lower extremity muscles. Subsequently, the same T2 weighted spin-echo sequence will be implemented with fat suppression (FS) and T2 FS maps are created. Based on the difference in proton density between the two spin-echo sequences the T2 FS pixels primarily composed of lipid will be eliminated, and the muscle lesion volume (% of unsuppressed pixels with elevated T2 values) will be recorded for each of the lower extremity muscles.
Change in base line in T2 weighted MRI of skeletal muscle in leg for Aim 1
Time frame: Change in baseline relative to 48 hours after exercise
Magnetic resonance imaging will be performed with a Philips 3.0T whole body scanner. Subjects will be positioned supine in the magnet. Multi-slice (6 axial slices) multi-echo (16 echoes with equal spacing from 20-320 ms) T2-weighted imaging will be performed on the upper leg (thigh). T2 maps of the thigh muscles will be created and mean T2 values of the knee extensor muscle group and flexor muscle group will be measured as well as the proportion of pixels defined as elevated (>2SD).
6 secondary outcomes
Change from baseline in Spectroscopic Relaxometry for Aim 2
Time frame: Change in baseline relative to 1 week, 6 weeks, 12 weeks
Change from baseline in Spectroscopic Relaxometry for Aim 1
Time frame: Change in baseline relative to 48 hours after exercise
Change from baseline in Creatine Kinase (CK) Levels for Aim 2
Time frame: Change in baseline relative to 1 week, 3 weeks, 6 weeks, 9 weeks, 12 weeks
Change from baseline in Creatine Kinase (CK) Levels for Aim 1
Time frame: Change in baseline relative to 48 hours after exercise
Change from baseline in Pain for Aim 2
Time frame: Change in baseline relative to 1 week, 3 weeks, 6 weeks, 9 weeks, 12 weeks
Change from baseline in Pain for Aim 1
Time frame: Change in baseline relative to 48 hours after exercise
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 6 Mar 2019.
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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, PhD, PT 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 Aim 2 Exercise group and Aim 1 Exercise Dosing in people with Duchenne Muscular Dystrophy, 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 8 inclusion and 6 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 6 Mar 2019. 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 weighted MRI of skeletal muscle in leg for Aim 2 (time frame: Change in baseline relative to 1 week, 6 weeks, 12 weeks). 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 6 Mar 2019.