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Trial registered on ANZCTR
Registration number
ACTRN12619000228189p
Ethics application status
Not yet submitted
Date submitted
31/01/2019
Date registered
18/02/2019
Date last updated
1/11/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Community Exercise for persons with multiple sclerosis
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Scientific title
Community Exercise for persons with multiple sclerosis - effect on exercise participation
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Secondary ID [1]
296856
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis
311337
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Condition category
Condition code
Neurological
309975
309975
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0
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Multiple sclerosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A home-based exercise programme will be delivered to persons with MS for up to 5 months as part of a randomised controlled study. This will be supervised by a physiotherapist or a supervised exercise physiologist student.
The exercise programme will be incrementally progressed over the first four months of the program to maximise participant success and adherence
The program will include 30 minute sessions of moderate-intensity aerobic walking and sessions approximately 30 minutes long of moderate-intensity resistance training per week. Please refer to Step 5 Eligibility, participants who respond yes to eligibility criteria (f) non-exercisers will follow the General aerobic activity and strength training plan which is 2 sessions of aerobic exercise and 2 sessions of resistance exercise per week. Participants who respond yes to eligibility criteria (g) aerobic exercisers will follow the Advanced aerobic activity and strength training plan which is 5 sessions of aerobic exercise and two sessions of resistance exercise per week.
Resistance exercises will target the lower body, upper body and core muscle groups, and example exercise are Chair Raises, and Shoulder Rows.
The incrementally progression of aerobic exercise will follow a general planned pattern; beginning with 10 min walking with the addition of 5 minutes every 2 weeks.
The incrementally progression of resistance exercise will follow a general planned pattern; beginning with 1 set, 10 repetitions of 5 exercise with increases of repetitions, then sets, and then number of exercises every 2 weeks.
Participants who choose to increase exercise above this amount will not be discouraged but will be asked to note this in their exercise diaries.
Participants will rate intensity using a Borg RPE scale.
Participants will complete exercise journal/diaries to promote adherence. Participants will receive text messages to encourage exercise, and telephone/video calls to encourage participation amd modify technique.
This addition will be for participants who on entering the study already engage in structured aerobic exercise on 2 or more occasions per week (and this information will be established on recruitment on the screening questionnaire)
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Intervention code [1]
313518
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Lifestyle
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Intervention code [2]
313617
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Treatment: Other
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Comparator / control treatment
The usual care will follow participants’ normal care. They will be requested to continue usual behaviour.
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Control group
Active
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Outcomes
Primary outcome [1]
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Exercise Participation via Godin Leisure Time Exercise Questionnaire
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Assessment method [1]
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Timepoint [1]
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Secondary outcome [1]
366340
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Mobility via the Multiple Sclerosis Walking Scale
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Assessment method [1]
366340
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Timepoint [1]
366340
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Secondary outcome [2]
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Balance via Activities Balance Confidence Questionnaire
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Assessment method [2]
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Timepoint [2]
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Secondary outcome [3]
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Fatigue via Fatigue Severity Scale
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Assessment method [3]
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Timepoint [3]
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Secondary outcome [4]
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Anxiety and depression via Hospital Anxiety and Depression Scale
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Assessment method [4]
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Timepoint [4]
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Secondary outcome [5]
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Quality of life via Leeds MS Quality of Life Scale
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Assessment method [5]
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Timepoint [5]
366800
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Secondary outcome [6]
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Quality of life via EuroQoL quality of life scale
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Assessment method [6]
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Timepoint [6]
366802
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Secondary outcome [7]
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Exercise related social cognitive factors associated with adherence via the Exercise Self efficacy scale.
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Assessment method [7]
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Timepoint [7]
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Secondary outcome [8]
366812
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Exercise related social cognitive factors associated with adherence via Behavioural Regulation in Exercise Questionnaire
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Assessment method [8]
366812
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Timepoint [8]
366812
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Secondary outcome [9]
366817
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Exercise related social cognitive factors associated with adherence via the Psychological Need Satisfaction scale
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Assessment method [9]
366817
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Timepoint [9]
366817
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Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
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Eligibility
Key inclusion criteria
(a) age above 18 years; (b) diagnosis of MS; (c) Patient Determined Disability Steps (PDDS) scale score equals 4.0 (i.e., mild or moderate disability consistent with the recommendations in the guidelines for exercise in MS); (d) relapse free in past 30 days; (e) willing and able to participate in a 5-month home-based exercise program and a 6 month follow-up; (f) non-exercisers (operationalized to be not engaging in 30 or more minutes of moderate intensity aerobic exercise on more than 2 days/week and 30 or more minutes of resistance training on more than 2 days/week); and (g) aerobic exercisers (operationalized to be engaging in 30 or more minutes of moderate intensity aerobic exercise on more than 2 days/week)
Participants who respond yes to eligibility criteria (f) non-exercisers will follow the General aerobic activity and strength training plan. Participants who respond yes to eligibility criteria (g) aerobic exercisers will follow the Advanced aerobic activity and strength training plan.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
None
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The effect of the intervention on primary and secondary outcomes will be examined using Condition by Time mixed-model ANOVA. Condition will be a between-subjects factor and
time will be a within-subjects factor. Interactions will be decomposed using post-hoc analyses with a correction of alpha. Effect sizes associated with F-statistics will be expressed as eta-squared. Effect sizes based on a difference in mean scores will be expressed as Cohen's d.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
16/01/2020
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Actual
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Date of last participant enrolment
Anticipated
24/07/2021
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Actual
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Date of last data collection
Anticipated
24/08/2022
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Murdoch University
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Address [1]
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90 South Street, Murdoch, WA 6150
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Country [1]
301428
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Australia
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Primary sponsor type
University
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Name
Murdoch University
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Address
90 South Street, Murdoch, WA 6150
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Country
Australia
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Secondary sponsor category [1]
301569
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None
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Name [1]
301569
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Address [1]
301569
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Country [1]
301569
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
302161
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Murdoch University Human Research Ethics Committee
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Ethics committee address [1]
302161
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90 South Street, Murdoch, WA 6150
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Ethics committee country [1]
302161
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Australia
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Date submitted for ethics approval [1]
302161
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18/02/2019
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Approval date [1]
302161
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Ethics approval number [1]
302161
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Summary
Brief summary
This project will seek to identify
1) If a home based exercise programme which includes telephone/internet calls and an email newsletter to encourage compliance and long term adherence can be delivered by healthcare professionals to persons with mild to moderate MS living in rural Australia.
2) What is the best model of delivery by first establishing a 1:1 (1 healthcare professional to 1 person with MS) method, and next establishing a 1:group (1 healthcare professional to >2 person with MS) method.
3) The training requirements for healthcare professionals to deliver the program.
4) What are the effects of the exercise program on outcomes of physical activity, MS symptoms, and exercise adherence.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Yvonne Learmonth
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Address
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Murdoch University
90 South St, Murdoch, WA 6150
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Country
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Australia
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Phone
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+61 893606373
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Yvonne Learmonth
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Address
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Murdoch University
90 South St, Murdoch, WA 6150
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Country
89339
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Australia
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Phone
89339
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+61 893606373
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Fax
89339
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Email
89339
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[email protected]
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Contact person for scientific queries
Name
89340
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Dr Yvonne Learmonth
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Address
89340
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Murdoch University
90 South St, Murdoch, WA 6150
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Country
89340
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Australia
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Phone
89340
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+61 893606373
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Fax
89340
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Email
89340
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
University embargo
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4110
Plain language summary
No
Still continuing
Documents added automatically
No additional documents have been identified.
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