Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000086662
Ethics application status
Approved
Date submitted
15/01/2014
Date registered
23/01/2014
Date last updated
20/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Resistance training with Partial Vascular Occlusion (VOT) in Inclusion Body Myositis (IBM). A single group interventional study: a pilot study to corroborate prior findings of VOT in the IBM population
Scientific title
Low intensity resistance training with blood flow to targeted muscles partially restricted: an effective strengthening regime for those with Inclusion Body Myositis?
Secondary ID [1] 283534 0
NONE
Universal Trial Number (UTN)
U1111-1152-1750
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inclusion Body Myositis 290447 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290838 290838 0 0
Physiotherapy
Inflammatory and Immune System 291335 291335 0 0
Other inflammatory or immune system disorders
Musculoskeletal 291336 291336 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 hour, 3 times/per 18 week strength exercise program in 2 phases targeting the quadriceps muscles in people in IBM. Sessions will held in as a group and supervised by a senior physiotherapist in a tertiary hospital.
Phase 1: establishing baseline. 5-6weeks of traditional moderate intensity strength training program (1 hour 3x/wk).
Exercises: squats, leg extensions, inner range quadriceps exercises, leg press.
repetitions: 8-12, 3 sets
Load: approx 60% of maximum lift

Phase 2: 12 weeks strength training at low intensity accompanied by partial occlusion of blood flow to quadriceps via blood pressure cuff placed around thigh. The cuff will remain inflated and around the thigh during exercises.
exercises: as above
repetitions: 15
load: 20-50% of maximum lift
occlusion pressures: ~50% of systolic blood pressure
Intervention code [1] 288597 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291267 0
Quadriceps strength:
Isokinetic and Isometric (at 15 and 90 degrees) using BioDex System 3 Dynamometer
Timepoint [1] 291267 0
Beginning of trial.
Commencement of training with partial occlusion.
End of training with partial occlusion
3 months following cessation of training.
Primary outcome [2] 291314 0
Mobility: Timed up and Go test (TUG)
Timepoint [2] 291314 0
Beginning of trial.
Commencement of training with partial occlusion.
End of training with partial occlusion
3 months following cessation of training.
Primary outcome [3] 291315 0
Functional questionnaire: Inclusion Body Myositis Functional Rating Scale (IBM-FRS)
Timepoint [3] 291315 0
Beginning of trial.
Commencement of training with partial occlusion.
End of training with partial occlusion
3 months following cessation of training.
Secondary outcome [1] 306381 0
Creatine Kinase
Timepoint [1] 306381 0
Beginning of trial.
Commencement of training with partial occlusion.
End of training with partial occlusion
3 months following cessation of training.
Secondary outcome [2] 306498 0
Falls Diary
Timepoint [2] 306498 0
Beginning of trial.
Commencement of training with partial occlusion.
End of training with partial occlusion
3 months following cessation of training.

Eligibility
Key inclusion criteria
Diagnosis of Inclusion Body Myositis
A minimum of household ambulant with or without an aid
Willing to participate exclusively in the studies exercise program (ie not participate in a formal concurrent thigh strengthening program)
Full range of knee extension
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-ambulant, unable to walk 10 meters
Peripheral vascular disease and/or compromised lower limb circulation
Coexistent neurological or psychiatric disease
Severe patella-femoral pain, knee osteoarthritis
Unstable medical condition - unstable angina, uncontrolled diabetes, uncontrolled hypertension

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potentially suitable subjects will be identified by a Consultant Neurologist. These subjects will then be phoned and invited to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/01/2015
Actual
29/01/2015
Date of last participant enrolment
Anticipated
27/02/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288555 0
Hospital
Name [1] 288555 0
Physiotherapy Department
Sir Charles Gairdner Hospital
Country [1] 288555 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital Physiotherapy Department
Address
QEII Medical Centre
Hospital Ave
Nedlands, WA
6009
Country
Australia
Secondary sponsor category [1] 287268 0
None
Name [1] 287268 0
None
Address [1] 287268 0
none
Country [1] 287268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290419 0
Sir Charles Gairdner Hospital Group Human Research Ethics Committee
Ethics committee address [1] 290419 0
2nd floor, A Block
QEII Medical Centre
Hospital Ave
Nedlands, WA
6009
Ethics committee country [1] 290419 0
Australia
Date submitted for ethics approval [1] 290419 0
06/11/2013
Approval date [1] 290419 0
17/01/2014
Ethics approval number [1] 290419 0
2013-198

Summary
Brief summary
To explore whether the relatively new form of resistance exercise which employs low resistances accompanied by restricting blood flood to targeted muscles (as know in Japan as Kaatsu training) can play a role in reducing the disability caused by inclusion body myositis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44126 0
Mr Dave Hathorn
Address 44126 0
Physiotherapy Department
SCGH
QE II Medical Centre, Grd floor A block
Hospital Ave
Nedlands, WA
6009
Country 44126 0
Australia
Phone 44126 0
+61 8 9346 2337
Fax 44126 0
Email 44126 0
[email protected]
Contact person for public queries
Name 44127 0
Mr Dave Hathorn
Address 44127 0
Physiotherapy Department
SCGH
QE II Medical Centre, Grd floor A block
Hospital Ave
Nedlands, WA
6009
Country 44127 0
Australia
Phone 44127 0
+61 8 9346 2337
Fax 44127 0
Email 44127 0
[email protected]
Contact person for scientific queries
Name 44128 0
Mr Dave Hathorn
Address 44128 0
Physiotherapy Department
SCGH
QE II Medical Centre, Grd floor A block
Hospital Ave
Nedlands, WA
6009
Country 44128 0
Australia
Phone 44128 0
+61 8 9346 2337
Fax 44128 0
Email 44128 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.