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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
Scientific title
Community Exercise for persons with multiple sclerosis - effect on exercise participation
Secondary ID [1] 296856 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis 311337 0
Condition category
Condition code
Neurological 309975 309975 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 313518 0
Lifestyle
Intervention code [2] 313617 0
Treatment: Other
Comparator / control treatment
The usual care will follow participants’ normal care. They will be requested to continue usual behaviour.
Control group
Active

Outcomes
Primary outcome [1] 318892 0
Exercise Participation via Godin Leisure Time Exercise Questionnaire
Timepoint [1] 318892 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
Secondary outcome [1] 366340 0
Mobility via the Multiple Sclerosis Walking Scale
Timepoint [1] 366340 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
Secondary outcome [2] 366791 0
Balance via Activities Balance Confidence Questionnaire
Timepoint [2] 366791 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
Secondary outcome [3] 366792 0
Fatigue via Fatigue Severity Scale
Timepoint [3] 366792 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
Secondary outcome [4] 366799 0
Anxiety and depression via Hospital Anxiety and Depression Scale
Timepoint [4] 366799 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
Secondary outcome [5] 366800 0
Quality of life via Leeds MS Quality of Life Scale
Timepoint [5] 366800 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
Secondary outcome [6] 366802 0
Quality of life via EuroQoL quality of life scale
Timepoint [6] 366802 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
Secondary outcome [7] 366811 0
Exercise related social cognitive factors associated with adherence via the Exercise Self efficacy scale.
Timepoint [7] 366811 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
Secondary outcome [8] 366812 0
Exercise related social cognitive factors associated with adherence via Behavioural Regulation in Exercise Questionnaire
Timepoint [8] 366812 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11
Secondary outcome [9] 366817 0
Exercise related social cognitive factors associated with adherence via the Psychological Need Satisfaction scale
Timepoint [9] 366817 0
Primary end point is Month 4
Assessments taken at
Baseline Line, Month 4, Month 5, Month 11

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
randomisation by computer
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/01/2020
Actual
Date of last participant enrolment
Anticipated
24/07/2021
Actual
Date of last data collection
Anticipated
24/08/2022
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301428 0
University
Name [1] 301428 0
Murdoch University
Country [1] 301428 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch, WA 6150
Country
Australia
Secondary sponsor category [1] 301569 0
None
Name [1] 301569 0
Address [1] 301569 0
Country [1] 301569 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302161 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 302161 0
Ethics committee country [1] 302161 0
Australia
Date submitted for ethics approval [1] 302161 0
18/02/2019
Approval date [1] 302161 0
Ethics approval number [1] 302161 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89338 0
Dr Yvonne Learmonth
Address 89338 0
Murdoch University
90 South St, Murdoch, WA 6150
Country 89338 0
Australia
Phone 89338 0
+61 893606373
Fax 89338 0
Email 89338 0
[email protected]
Contact person for public queries
Name 89339 0
Yvonne Learmonth
Address 89339 0
Murdoch University
90 South St, Murdoch, WA 6150
Country 89339 0
Australia
Phone 89339 0
+61 893606373
Fax 89339 0
Email 89339 0
[email protected]
Contact person for scientific queries
Name 89340 0
Yvonne Learmonth
Address 89340 0
Murdoch University
90 South St, Murdoch, WA 6150
Country 89340 0
Australia
Phone 89340 0
+61 893606373
Fax 89340 0
Email 89340 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
University embargo


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Still continuing

Documents added automatically
No additional documents have been identified.