Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000490673
Ethics application status
Approved
Date submitted
15/04/2014
Date registered
12/05/2014
Date last updated
12/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of eccentric exercise on calf muscle contracture in people with multiple sclerosis
Scientific title
In people with multiple sclerosis, do eccentric exercises, compared with routine stretching, reduce contracture in ankle joint and calf muscle?
Secondary ID [1] 284444 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle joint contracture 291653 0
Multiple sclerosis 291654 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292040 292040 0 0
Physiotherapy
Musculoskeletal 292041 292041 0 0
Other muscular and skeletal disorders
Neurological 292042 292042 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in intervention group will be exercising under supervision at a university-based gym two times each week for twelve weeks. Each exercise session will last about 45-60 minutes. The exercise involves walking backwards and downhill on a treadmill. This type of exercise is known to produce muscle soreness - the same sort of soreness that people normally experience after they participate in unaccustomed physical activity. We expect that, if participants in intervention group will experience muscle soreness. However, the soreness will gradually be less and less over the 12-week period. To minimize this muscle soreness, participants will be trained at low intensity at start and gradually increased intensity over the first 8 sessions.
Intervention code [1] 289196 0
Rehabilitation
Intervention code [2] 289345 0
Treatment: Other
Comparator / control treatment
home-based exercises, including stretching the ankle, to practice at home for 20-30 minutes at least 2 times per week over the 12 week treatment period. Home-based exercises will involve strengthening exercises for affected muscle groups (e.g. hip flexors, knee flexors or ankle dorsiflexors). Participants will learn these exercises at base line testing. The exercises will be either recorded on participant's smart phone or on papers if they do not use smart phones. Adherence to exercises will be monitored monthly by phone calls.
Control group
Active

Outcomes
Primary outcome [1] 291921 0
passive ankle dorsiflexion range of motion of the affected leg at 12Nm using a Cybex equipment (Humac Norm)
Timepoint [1] 291921 0
Baseline (before training) and at completion of 12-week training (or 24 sessions)
Secondary outcome [1] 307823 0
The passive mechanical properties of the gastrocnemius muscle including: passive slack length of the gastrocnemius muscle-tendon unit, passive muscle fascicle slack length as well as length–tension curves of the muscle fascicles and tendons. The outcomes are derived from using ultrasound in combination with measurements of passive ankle torques at difference knee angles (Hoang et al, 2007).
Timepoint [1] 307823 0
Baseline (before training) and at completion of 12-week training (or 24 sessions)
Secondary outcome [2] 307824 0
Mobility capacity (10-meter and 6-minute Walk tests)

Timepoint [2] 307824 0
Baseline (before training) and at completion of 12-week training (or 24 sessions)
Secondary outcome [3] 307825 0
Gait parameters (step length and gait symmetry) using Gaitrite mat
Timepoint [3] 307825 0
Baseline (before training) and at completion of 12-week training (or 24 sessions)
Secondary outcome [4] 307826 0
Frequency of accidental falls during the intervention and 3 months after completion. Incidents of falls are collected by using Falls diary: participants in both groups will be given 6 monthly calendars and 6 "reply paid" envelopes. Participants will be asked to record date and time falls (defined as inadvertently ended on the ground during daily activities) and consequences if any (e.g. bruise, broken bones). Calendars are sent back to investigators monthly.
Timepoint [4] 307826 0
During 12-week training and 3 month follow-up after completion of training

Eligibility
Key inclusion criteria
* A definite diagnosis of multiple sclerosis (MS), confirmed by neurologists
* Less than 90 degrees of ankle dorsiflexion range of motion when a dorsiflexion torque of 12 Nm is applied to the relaxed ankle
* Have EDSS scale between 1 and 5
* Able to understand spoken English and follow instructions during testing and exercise
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Being unable to give informed consent, or
* Have received a Botox injection for their calf muscles in the past 6 months or expect to receive a Botox injection for their calf muscles in the subsequent 12 weeks
* Have been advised by a medical doctor not to do exercise
* Had a relapse (or attack) of MS in the previous 30 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to one of two groups - an Eccentric Training group or a Control group - using a simple (unrestricted) allocation procedure. The allocation schedule will be drawn up by a person who is not otherwise involved in the trial. This will be concealed from the researchers involved in recruitment, consent and assessment procedures. After potential participants have given consent and baseline measures have been taken the allocation will be determined by contacting the person holding the allocation sequence. The participant will be considered to have entered the trial when the allocation is divulged.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289094 0
Other
Name [1] 289094 0
Neuroscience Research Australia
Country [1] 289094 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Street Address:
NeuRA
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 287755 0
Charities/Societies/Foundations
Name [1] 287755 0
Multiple Sclerosis Research Australia
Address [1] 287755 0
Street address:
Level 26, Northpoint, 100 Miller Street, North Sydney NSW 2060
Country [1] 287755 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290881 0
Australia Catholics University HREC
Ethics committee address [1] 290881 0
Ethics committee country [1] 290881 0
Australia
Date submitted for ethics approval [1] 290881 0
Approval date [1] 290881 0
28/11/2013
Ethics approval number [1] 290881 0
2013 312N
Ethics committee name [2] 290882 0
University of New South Wales HREC
Ethics committee address [2] 290882 0
Ethics committee country [2] 290882 0
Australia
Date submitted for ethics approval [2] 290882 0
18/04/2014
Approval date [2] 290882 0
Ethics approval number [2] 290882 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 33 33 0 0
/AnzctrAttachments/366173-Approval from ACU.pdf
Attachments [2] 34 34 0 0
/AnzctrAttachments/366173-Previous UNSW Ethics Approval.pdf
Attachments [3] 35 35 0 0
/AnzctrAttachments/366173-HC14073 Letter from 01 Apr2014 Meeting-1.pdf

Contacts
Principal investigator
Name 47750 0
Dr Phu Hoang
Address 47750 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031

Country 47750 0
Australia
Phone 47750 0
+61 2 9399 1832
Fax 47750 0
Email 47750 0
[email protected]
Contact person for public queries
Name 47751 0
Phu Hoang
Address 47751 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031
Country 47751 0
Australia
Phone 47751 0
+61 2 9399 1832
Fax 47751 0
Email 47751 0
[email protected]
Contact person for scientific queries
Name 47752 0
Phu Hoang
Address 47752 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031
Country 47752 0
Australia
Phone 47752 0
+61 2 9399 1832
Fax 47752 0
Email 47752 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.