|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01618331 |
|
Date of registration:
|
07/06/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study
FSHD |
|
Scientific title:
|
The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT Study |
|
Date of first enrolment:
|
March 2012 |
|
Target sample size:
|
42 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01618331 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Verified FSHD
- Age 18-65
- Untrained. Less than two hours cardio-training each week the last 4 month.
Exclusion Criteria:
- Competitive disorders
- Pregnant and breastfeeding
- Unable to walk 200 m within 6 min.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Facioscapulohumeral Muscle Dystrophy
|
|
Intervention(s)
|
|
Behavioral: Regular exercise
|
|
Dietary Supplement: Protein-carbohydrate supplementation
|
|
Primary Outcome(s)
|
|
6MWT
[Time Frame: up to Week 12]
|
|
Maximal oxygen consumption test
[Time Frame: up to Week 12]
|
|
Secondary Outcome(s)
|
|
Blood samples
[Time Frame: week: 0, 4, 7, 10, 12]
|
|
Daily activity level
[Time Frame: week: 0 and 12]
|
|
Risk of falls
[Time Frame: week: 0 and 12]
|
|
Secondary ID(s)
|
|
H-1-2011-149
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|