Trial · NCT04054375
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fasting Glucose | Baseline and 6 months (Final Visit) | mg/dL, 0-unlimited, higher score indicates worse outcome |
| Primary | HbgA1c | Baseline and 6 months (Final Visit) | % , 0-100, higher score indicates worse outcome |
| Primary | Fasting Lipid Profile | Baseline and 6 months (Final Visit) | cholesterol levels - mg/dL, higher levels indicate worse outcomes |
| Primary | Creatine Kinase | Baseline and 6 months (Final Visit) | units/L, 0-unlimited, higher scores indicate worse outcome |
| Primary | Respiratory Changes | Baseline, 6 months | Force Vital Capacity (% of predicted value), decrease in FVC indicates declining respiratory function. |
| Secondary | Functional Assessments - NSAD Change | Baseline, Month 6 | Northstar Assessment for Dysferlinopathy \- score out of 58, range from 0 to 58, higher score indicates greater functional ability. |
| Secondary | 6 Minute Walk Test | Baseline, Month 6 | number of meters walked in 6 minute period. Higher values indicate more motor function. |
| Secondary | 10 Meter Run Timed | Baseline, Month 6 | time in seconds to walk/run 10 meters , less time to run indicates greater motor function |
| Secondary | Brooke Scale Score | Baseline, Month 6 | upper extremity assessment, scoring between 1- 6, lower score indicates more upper extremity function |
| Secondary | Vignos Scale Score | Baseline, Month 6 | Lower extremity assessment, score from 1-10, lower score indicates more function. |
| Secondary | Muscle Imaging | Baseline, 6 months | MRI of leg muscles to measure changes in muscle fat percentage. The data point was collected by taking fat percentage at 6 months minus fat percentage at baseline with the following equation: ((\[final fat percentage - initial fat percentage\]/initial fat percentage) \* 100%)). All participants were included, both ambulatory and nonambulatory, with all genetic subtypes included. Five participants didn't have an MRI scan at 6 months and therefore were not included. Muscles imaged were analyzed for muscle fat changes from baseline to 6 months. Data is limited in interpretation due to various muscle groups in both ambulatory and non-ambulatory patients. |
| Secondary | Bone Density | Baseline, 6 months | whole dexa body scan to assess bone density with Z scores (more negative z score indicates increased risk for fractures). Z-score of 0 represents the population mean, and is the average bone density. Positive scores indicate greater bone density and negative scores indicate decreased bone density, which could be clinically correlated with osteoporosis. |
| Secondary | Lean Mass % | Baseline, 6 months | whole body dexa scans to assess lean mass % (0- 100 %). Increase lean mass % is the desired outcome. |
| Secondary | Functional Assessments - Upper Limb Strength | Baseline and 6 months | Grip strength of the total force (Newtons) in both hands. Participants attempted 3 trials in the right hand that was then averaged to create a right-hand average force score. Then, the participants attempted 3 trials in the left hand that was then averaged to create a left-hand average force score. The right-hand average force score was added to the left-hand average force score to create a total grip strength score. |
| Secondary | Muscle Strength Test | baseline, 6 months | Manual motor testing of the right knee flexion muscle group. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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