ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000076976

Ethics application status

Approved

Date submitted

8/01/2020

Date registered

30/01/2020

Date last updated

30/01/2020

Date data sharing statement initially provided

30/01/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Finding the right balance with participation in exercise and sport for individuals with multiple sclerosis

Scientific title

Finding the right balance with participation in exercise and sport for individuals with multiple sclerosis: A protocol for a pre/post intervention feasibility study.

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multiple sclerosis

Condition category

Condition code

Neurological

Multiple sclerosis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All participants will undertake a Flexible Exercise Participation Program (FEPP) which is a 12-week program, in which participants choose their preferred mode of aerobic exercise (e.g. running, cycling, swimming, walking) as well as the time and location (e.g. indoor or outdoor setting) for exercise. The FEPP is a personally tailored exercise program to achieve exercise participation goals specific to the individual and is guided by the individual’s perceived energy levels.

The FEPP has two streams to enable progression of activity level relative to the individual’s baseline activity level. Stream 1 is for participants who do not meet the MS general aerobic exercise guidelines of at least 30 minutes of moderate intensity aerobic exercise three times per week (1). Moderate intensity exercise is defined as 40-59% of heart rate reserve and can be scored as 12-13 on a 6-20 rating of perceived exertion (RPE) scale (2). Participants progress through the stream modifying frequency and duration of exercise, guided by the FEPP, until they reach the MS general aerobic exercise guidelines (1). Participants can opt to maintain this activity level for the remainder of the program if they are satisfied with their participation in their chosen sport or exercise in accordance with their goals. Alternatively, participants can progress through stream 2.

Stream 2 is for participants who meet MS general aerobic exercise guidelines. This stream is designed to incrementally progress exercise towards meeting or exceeding the MS advanced aerobic exercise guidelines (1). These guidelines recommend an exercise duration approaching 40 minutes; frequency approaching 5 days per week and intensity approaching 15 on a 6-20 point RPE scale (1). Participants progress through the stream by modifying frequency, intensity and duration of exercise until they are satisfied with their participation in their chosen sport or exercise in accordance with their goals. Participants continue with their optimum participation for the duration of the program.

Prior to and throughout the 12-week period, participants will be supported to participate in exercise or sport via a 30-minute coaching session with a physiotherapist, once each week, via telephone. Behaviour change techniques known to assist with participation in exercise and sport (3) will be used. These techniques are: goal setting; action planning; barrier identification; self-monitoring and performance feedback. Goal setting, action planning and barrier identification will be explored in the initial interview with the participant. Weekly coaching sessions will continue to explore action planning and address any ongoing barriers if present. Self-monitoring will be weekly via completion of the exercise diary. Performance feedback will occur weekly in the coaching session. Goals will be reviewed in accordance with the time frame of the set goals.

Progression of exercise with the FEPP is guided by the individual’s perceived energy levels. Participants will monitor and respond to energy levels, use a pacing technique to manage energy effectively, thereby enabling participation. A FEPP flowchart will also guide the participant to incrementally progress, maintain or regress their exercise based on performance feedback. The FEPP flowchart has been based on existing aerobic exercise guidelines for individuals with MS (1).

An exercise diary will be used to record exercise adherence and participation.

1. Kim Y, Lai B, Mehta T, et al. Exercise training guidelines for multiple sclerosis, stroke, and Parkinson disease: Rapid review and synthesis. Am J Phys Med Rehabil. Jul 2019;98(7):613-621. doi: 10.1097/PHM.0000000000001174.
2. American College of Sports Medicine. ACSM's guidelines for exercise testing and prescription 10th ed. Philadelphia, Pennsylvania: Wolters Kluwer Health; 2018.
3. Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. Nov 2011;26(11):1479-1498. doi: 10.1080/08870446.2010.540664.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary outcome is assessment of feasibility metrics in each of the following domains: process, resources, management and scientific. Assessment of the feasibility metrics will be via audit of the collected data for each domain. Further data on each domain and documentation of the collected data is provided below:

Process Metrics:
• Recruitment
• Eligibility
• Refusals
• Retention
• Attrition
• Adherence
Process Documentation Examples: Contact with potential participants. Participant flow through study. Adherence via exercise diary.

Resource Metrics:
• Communication
• Finance
Resource Documentation Examples: Duration and frequency of communication between participants/staff (email, telephone, face to face contact). Communication difficulties (assessment via focus group interviews and participant questionnaire which was designed specifically for the study). All costs associated with study which include: research costs (e.g. staffing, blood analysis, phone bills) and participant costs (e.g. exercise participation/equipment and transport costs).

Management Metrics:
• Data management
• Staff management
Management Documentation Examples: Data collection times. Data entry and checking of data. Staffing requirements.

Scientific Metrics:
• Adverse events
• Safety
• Compliance
Scientific Documentation Examples:
Documentation of adverse and serious adverse events (e.g. falls, heat fatigue) via - exercise diary ; weekly check-in with physiotherapist; reporting safety concerns and adverse events as per university policy.
Documentation of compliance - via exercise diary and weekly check-in.

Timepoint [1]

Feasibility metrics collected throughout the 12 week period and finalised at 12 weeks after intervention commencement

Secondary outcome [1]

Level of exercise participation assessed using the Goal Attainment Scale

Timepoint [1]

12 weeks after intervention commencement

Secondary outcome [2]

Composite secondary outcome
Plasma cytokine levels (IL-2, IL-4, IL-6, IL-10, IFN-gamma and TNF), using the commercially available kit: BD Cytometric Bead Array (CBA) Hu Th1/Th2 Cytokine Kit II.

Timepoint [2]

Baseline and 13 weeks after intervention commencement

Secondary outcome [3]

Subjective vitality measured using the Subjective Vitality Scale

Timepoint [3]

Baseline, weeks 4, 8 and 12

Secondary outcome [4]

High level mobility measured using the High-level mobility assessment tool (HiMAT)

Timepoint [4]

Measured at baseline and 13 weeks after intervention commencement

Secondary outcome [5]

Exercise activity measured with a weekly exercise diary

Timepoint [5]

Every week for the 12 weeks of intervention

Secondary outcome [6]

Participants' perception of the FEPP will be measured by a questionnaire which was designed specifically for this study. Three key areas: satisfaction, usability and suitability, will be explored in a short survey using a five-point Likert scale based on similar surveys used with individuals with MS 1,2.

1. Learmonth YC, Adamson BC, Kinnett-Hopkins D, Bohri M, Motl RW. Results of a feasibility randomised controlled study of the guidelines for exercise in multiple sclerosis project. Contemp Clin Trials. Mar 2017;54:84-97. doi: 10.1016/j.cct.2016.11.012.
2. Aminian S, Motl RW, Rowley J, Manns PJ. Management of multiple sclerosis symptoms through reductions in sedentary behaviour: protocol for a feasibility study. BMJ Open. Apr 1 2019;9(4):e026622. doi: 10.1136/bmjopen-2018-026622.

Timepoint [6]

Following completion of the intervention at 12 weeks

Secondary outcome [7]

Participants' perceptions of the FEPP measured by focus group interviews

Timepoint [7]

During a 6 week period post 12 week intervention

Eligibility

Key inclusion criteria

(i) diagnosis of relapsing remitting MS as defined by the 2017 McDonald criteria; (ii) independent mobility as defined by Expanded Disability Status Scale (EDSS) level 0-3.5 33; (iii) stable i.e. not worsening in past three months on disease modifying drugs (e.g. alemtuzamab, natalizumab and ocrelizumab); (iv) aged 18 years or over; (v) able to provide informed consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(i) any concomitant neurological condition or (ii) an additional health condition that would prohibit their participation in aerobic exercise or sport.

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

31/01/2020

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4811 - James Cook University

Funding & Sponsors

Funding source category [1]

University

Name [1]

James Cook University

Address [1]

I Douglas Drive, Townsville, QLD, 4811

Country [1]

Australia

Primary sponsor type

University

Name

Moira Smith

Address

College of Healthcare Sciences
James Cook University
1 Douglas Drive
Townsville
QLD
4811

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

James Cook University, Human Research Ethics Committee

Ethics committee address [1]

Human Ethics, Research Office
James Cook University, Townsville, Qld, 4811

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2019

Approval date [1]

06/12/2019

Ethics approval number [1]

H7956

Summary

Brief summary

The objective of this study is to assess the feasibility of a Flexible Exercise Participation Program (FEPP) for people with minimal disability from multiple sclerosis. The 12-week FEPP will guide participants to independently participate in their preferred sport or exercise at a location of their choice. Exercise progression will be guided by individual energy levels and a weekly telephone coaching session with a physiotherapist. Participation in exercise or sport will be recorded in parallel with assessment of disease biomarkers, subjective vitality and high-level mobility. The aim of the study is to help increase participation in sport or exercise for people with multiple sclerosis.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Moira Smith

Address

Building 043-114
James Cook University
1 Douglas Drive
Townsville
QLD
4814

Country

Australia

Phone

+61 7 47816003

Fax

[email protected]

Contact person for public queries

Name

Ms Moira Smith

Address

Building 043-114
James Cook University
1 Douglas Drive
Townsville
QLD
4814

Country

Australia

Phone

+61 7 47816003

Fax

[email protected]

Contact person for scientific queries

Name

Ms Moira Smith

Address

Building 043-114
James Cook University
1 Douglas Drive
Townsville
QLD
4814

Country

Australia

Phone

+61 7 4781 6003

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6345	Study protocol				Awaiting publication

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Finding the right balance with participation in exercise and sport for individuals with multiple sclerosis: Protocol for a pre and post intervention feasibility study.	2020	https://dx.doi.org/10.1136/bmjopen-2019-035378

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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