Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000245796
Ethics application status
Approved
Date submitted
25/02/2013
Date registered
1/03/2013
Date last updated
9/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-management and Multiple Sclerosis: The impact of a community-based exercise and education program
Scientific title
A pilot randomised controlled trial investigating the effectiveness and feasibility of a self-management community group program (MANAGE) for improving mobility in Multiple Sclerosis.
Secondary ID [1] 282019 0
Nil Known
Universal Trial Number (UTN)
U1111-1139-8360
Trial acronym
MANAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 288465 0
Condition category
Condition code
Neurological 288810 288810 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 288811 288811 0 0
Physiotherapy
Public Health 288852 288852 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants will attend a 12 week program twice a week, consisting of twice weekly group exercise (60 minutes duration each) and once weekly education sessions (60 minutes duration) for six weeks, based at the Physiotherapy Department. Their exercise program will be individually-tailored after a physiotherapy assessment. In week 7 participants will complete their twice weekly group exercise sessions at a community gym. In week 8 participants will be accompanied to a local community exercise option, chosen in the first 6 weeks, with a hospital based health professional. They will be supported to attend this option for a minimum of once weekly for the remainder of the program (weeks 9-12) with support from hospital and trained community exercise location staff. The education sessions will cover principles of self-management, redefining problems, goal setting, facilitators to exercise, solutions to exercise barriers, strategies to manage fatigue & exercise, and community resources. The education sessions will be facilitated by a physiotherapist and an exercise physiologist in a group setting with 6 participants.
Intervention code [1] 286600 0
Rehabilitation
Comparator / control treatment
The control group will be a waitlist control group. They will continue with no treatment and will attend assessment sessions only. This group will be offered the opportunity to participate in a program after study completion.
Control group
Active

Outcomes
Primary outcome [1] 288951 0
Walking speed as measured with then 10 metre walk test with a minimal detectable change of 0.1 metres per second.
Timepoint [1] 288951 0
Baseline, 6 weeks, 12 weeks, 24 weeks after intervention commencement.
Secondary outcome [1] 301422 0
Walking endurance as measured with the 6 minute walk test
Timepoint [1] 301422 0
Baseline, 6 weeks, 12 weeks, 24 weeks after intervention commencement.
Secondary outcome [2] 301423 0
Standing balance as measured with the functional reach test.
Timepoint [2] 301423 0
Baseline, 6 weeks, 12 weeks, 24 weeks after intervention commencement.
Secondary outcome [3] 301424 0
Fatigue as measured by the Fatigue Severity Scale.
Timepoint [3] 301424 0
Baseline, 6 weeks, 12 weeks, 24 weeks after intervention commencement.
Secondary outcome [4] 301425 0
Broad impact of Multiple Sclerosis as measured by the Multiple Sclerosis Impact Scale
Timepoint [4] 301425 0
Baseline, 6 weeks, 12 weeks, 24 weeks after intervention commencement.
Secondary outcome [5] 301426 0
Perceived benefits and barriers to exercise as measured by the Exercise Benefits and Barriers Scale.
Timepoint [5] 301426 0
Baseline, 6 weeks, 12 weeks, 24 weeks after intervention commencement
Secondary outcome [6] 301427 0
Physical activity levels via self-report for the week prior to assessment.
Timepoint [6] 301427 0
Baseline, 24 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Multiple Sclerosis diagnosed by medical practitioner, Extended Disability Status Scale (EDSS) 0-6.5 (i.e. at a minimum be able to walk 20m with bilateral support), reside within RMH RPC Community Therapy Service catchment area, and currently not receiving or wait-listed for outpatient therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medically unstable (e.g. unstable cardiovascular disease or uncontrolled seizures) or other medical condition that would preclude participation in the program or confound results of the trial (e.g. severe arthritis, amputation or other neurological disorder).

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)
The MS clinic register at the RMH Royal Park Campus will be screened for potential eligible participants. Potential participants will be contacted by telephone utilising a standardised script to ascertain interest in study participation. Informed consent will be obtained from participants at the baseline assessment. Following baseline assessment, participants will be randomly allocated to intervention or usual care group using an electronic randomisation schedule managed by a clinician not involved in the research. Allocation will be concealed from the blinded assessor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated simple randomisation into intervention or usual care group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Baseline characteristics and feasibility data will be summarised using descriptive statistics and groups will be compared with respect to demographic and prognostic factors using Independent t-tests or Mann-Whitney-U tests. Repeated measures analysis of variance (ANOVA) will be used to compare changes over time and between group comparisons of changes in the primary and secondary outcome measures. Descriptive statistics will be used to summarise the characteristics of any drop outs and to analyse feasibility outcomes. The level of significance will be set at 0.05. Analyses will be on an intention-to-treat basis and results will be reported in accordance with the CONSORT criteria

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/03/2013
Actual
17/04/2013
Date of last participant enrolment
Anticipated
31/01/2014
Actual
30/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 668 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 6406 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 286794 0
Hospital
Name [1] 286794 0
Melbourne Health Research Funding Program
Country [1] 286794 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
The Royal Melbourne Hospital – Royal Park Campus, 34-54 Poplar Road, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 285585 0
None
Name [1] 285585 0
Address [1] 285585 0
Country [1] 285585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288861 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 288861 0
The Royal Melbourne Hospital
Office for Research
Level 6 East, Main Building,
300 Grattan St, Carlton VIC 3050
Ethics committee country [1] 288861 0
Australia
Date submitted for ethics approval [1] 288861 0
Approval date [1] 288861 0
15/01/2013
Ethics approval number [1] 288861 0
2012.242

Summary
Brief summary
This pilot study will investigate if an exercise and education program is useful to help keep persons with Multiple Sclerosis exercising in the community by themselves. We hypothesise that the program will improve walking speed and be a feasible and safe program.
Trial website
Trial related presentations / publications
Louie, J., Baquie K.A., Offerman J., Bower K.J., Granger C.L., Khan, F. (2015) Maximising abilities, negotiating and generating exercise options (manage) program: a pilot randomised controlled trial in persons with Multiple Sclerosis. Physiotherapy; 101, supplement 1. (02/05/2015)
Public notes

Contacts
Principal investigator
Name 38118 0
Ms Julie Louie
Address 38118 0
Physiotherapy Department
The Royal Melbourne Hospital – Royal Park Campus
34-54 Poplar Road, Parkville VIC 3052
Country 38118 0
Australia
Phone 38118 0
+61 3 83872685
Fax 38118 0
+61 3 83872109
Email 38118 0
[email protected]
Contact person for public queries
Name 38119 0
Ms Julie Louie
Address 38119 0
Physiotherapy Department
The Royal Melbourne Hospital – Royal Park Campus
34-54 Poplar Road, Parkville VIC 3052
Country 38119 0
Australia
Phone 38119 0
+61 3 83872685
Fax 38119 0
+61 3 83872109
Email 38119 0
[email protected]
Contact person for scientific queries
Name 38120 0
Ms Julie Louie
Address 38120 0
Physiotherapy Department
The Royal Melbourne Hospital – Royal Park Campus
34-54 Poplar Road, Parkville VIC 3052
Country 38120 0
Australia
Phone 38120 0
+61 3 83872685
Fax 38120 0
+61 3 83872109
Email 38120 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
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Documents added automatically
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