|
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:
|
2 November 2015 |
|
Main ID: |
NCT02317094 |
|
Date of registration:
|
10/12/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Blood-flow Restricted Exercise in Inclusion Body Myositis
|
|
Scientific title:
|
Low-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled Trial |
|
Date of first enrolment:
|
January 2015 |
|
Target sample size:
|
22 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02317094 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Anders N Jørgensen, PhD Student |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Southern Denmark |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Clinical features
- Duration of weakness > 12 months
- Weakness of finger flexors > shoulder abductors AND knee extension > hip flexion
Pathologic features
- Invasion of nonnecrotic fibres of mononuclear cells or rimmed vacuoles or
- increased major histocompatibility complex I (MHC-1) but no intracellular amyloid
deposits or 15-18nm filaments
Exclusion Criteria:
- Lack of gait function
- Co-morbidity contraindicating the use of blood-flow restricted training (previous
deep vein thrombosis/pulmonary embolism or known peripheral ischemic disease).
- Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled
hypertension (systolic > 160mmHg, diastolic > 100mmHg), severe knee/hip arthritis)
Age minimum:
35 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Sporadic Inclusion Body Myositis
|
|
Intervention(s)
|
|
Drug: Care as usual
|
|
Other: Blood-flow restricted training
|
|
Primary Outcome(s)
|
|
Patient reported physical function (health survey (SF-36) subscale: Physical Function)
[Time Frame: 12 wks]
|
|
Secondary Outcome(s)
|
|
Health assessment questionnaire (HAQ)
[Time Frame: 12 wks]
|
|
Manual Muscle Testing (MMT)
[Time Frame: 12 wks]
|
|
Myositis Damage Index
[Time Frame: 12 wks]
|
|
Chair rise
[Time Frame: 12 wks]
|
|
Inclusion body myositis functional rating scale (IBMFRS)
[Time Frame: 12 wks]
|
|
Physician/Patient Global Damage (VAS scale)
[Time Frame: 12 wks]
|
|
Timed up & go
[Time Frame: 12 wks]
|
|
2-min walk test
[Time Frame: 12 wks]
|
|
Physician/Patient Global activity (VAS scale)
[Time Frame: 12 wks]
|
|
Myositis Disease Activity Assessment Tool (MDAAT)
[Time Frame: 12 wks]
|
|
Secondary ID(s)
|
|
S-20120166
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|