Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000998549
Ethics application status
Approved
Date submitted
2/08/2024
Date registered
16/08/2024
Date last updated
16/08/2024
Date data sharing statement initially provided
16/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of online delivery of the MS-Get-a-Head-Start programme on physical activity self-efficacy of people with multiple sclerosis: a randomised pilot trial.
Scientific title
The effect of online delivery of the MS-Get-a-Head-Start programme on physical activity self-efficacy of people with multiple sclerosis: a randomised pilot trial.
Secondary ID [1] 312628 0
None
Universal Trial Number (UTN)
U1111-1311-2025
Trial acronym
MSGHS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 334580 0
Condition category
Condition code
Neurological 331178 331178 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 331305 331305 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Name:
The online MS Get a Head Start (MSGHS)

2. What:
This study specifically refers to the ONLINE Multiple Sclerosis (MS) Get a Head Start programme. The six-week interval-based exercise and education programme is delivered fully online via prerecorded videos. The programme commences with participants watching a 20-minute welcome video that introduces them to the programme and outlines what they should expect. It also covers educational information on proactive heat sensitivity management and setting up a safe exercise space. Each week the participants receive an email with two exercise videos and one education video to watch.

All participants receive an online PDF course handbook prior to starting and are also offered a physical copy of the programme posted to them. The handbook provides all the supporting education material for the intervention. This includes the education sections for each week as well as goal setting, activity diary recording, and weekly reflective work.

Participants are encouraged to have a sturdy chair and either an exercise mat or a towel /rug on which they can complete floor exercises. No further exercise equipment is needed.

3. Procedure for the Auckland University of Technology (AUT) “The effect of online delivery of the MS-Get-a-Head-Start programme on physical activity self-efficacy of people with multiple sclerosis: a randomised pilot trial”
a. Advertising flyer distributed
b. Potential participants directed to the website with the participant information form and short explanatory video
c. Interested participants email the researcher and can ask any further questions about the study via email or a scheduled a phone call. If still interested, the researcher then emails them a link to fill out a form gathering key screening information. If suitable, they are directed to complete the following screening questionnaires;
i. Physical Activity Readiness Questionnaire
ii. The patient-determined disease steps screening measure
d. If the participants meet the inclusion requirements they will be emailed a link to complete the consent form online.
e. Once the consent form is completed they will then be randomized into either the intervention group or the waitlist control group. The intervention group will be sent a link to register themselves to the online MSGHS programme, this will then start the automated programme. Both groups will be emailed a link which asks them to provide some basic demographic data (age, gender, ethnicity, and which region they live in) and will be asked to complete the outcome measures at week 0, week 7 and week 12.
f. Once the intervention group registers for the MSGHS programme they receive an automated welcome email containing the supporting PDF booklet, welcome video and the link to complete the outcome measures. They can download and save the workable PDF booklet on their own computer. We do not collect any data from the PDF workbook. They will be given the option to request a hard copy of the booklet to be sent to them if they prefer.
g. The intervention group then receives one email each week for 6 weeks. This email contains two exercise videos and one education video. It also details what the expected course work is for that week and asks the participants to reply to the email if they have experienced and injuries, issues or adverse events during the programme.
h. The exercise videos deliver interval training, which gradually increases over the 6 weeks. The rest period to exercise is a 1:1 ratio between each set. There are nine different exercises delivered in each video. Participants are encouraged to take at least a 1 minute rest after the third and sixth exercise, but can pause the video to extend this rest if needed.
i. The nine exercises are a combination of cardiovascular, strength and balance exercises. Participants are encouraged to work as hard as they can during each exercise. Encouraging a vigorous level of intensity as 8/10 on BORG rating of perceived exertion. An explanation on what “hard” can feel like safely is explained in the welcome video. Each exercise is demonstrated and then options of regressions and progressions are demonstrated to allow participants to find a level that is appropriate for them. The exercise videos last for approximately 35 – 45 minutes and safety introduction is provided at the start of each video. Participants are encouraged to leave at least one day between completing the first exercise video of the week and then the second.
j. For an example of exercises provided, exercises delivered in week 1 session 1; calf raises, sit to stand, speed box, 4 point kneeling leg extension, bridging, plank, standing feet together head turns, tandem stand, toe extension stretch. Exercises delivered in week 1 session 2; seated dorsiflexion, seated wrist extension, standing 1 leg alphabet, supine table top holds, side plank, side leg lifts, standing knee flexion, heel kicks in standing, prone quad stretch.
k. Each education video lasts approximately 30 – 40 minutes and the PDF handout of the power point presented is attached to each weekly email. The six topics discussed are fatigue management, exercise prescription, pain management, cognitive management and psychological wellbeing, other services, where to from here. The main education points are also delivered within the MSGHS PDF booklet.
l. Each week participants are also asked to complete course work weekly, include goal setting, exercise schedule and diary, reflections and key activities to support regularly physical activity.
m. All the participants have access to all the exercise and education videos provided at the end of the programme via their own login to the MSGHS website. They have access to these for 12 months.

4. Who is Providing:
Gilly Davy is the founder and clinical lead of the MSGHS programme and has provided all online recordings. She has a BSc Hons Physiotherapy and Post Grad Certificate in Health and Rehabilitation Science. With 20 years of experience as a clinical neurological physiotherapist, she has spent the last 15 years specialising in assessing and treating individuals with multiple sclerosis.

MSGHS is a company that also provides health professional education courses both online and in person www.ms-ghs.com

5. How:
The programme is delivered online via pre-recorded material that is provided in automated weekly emails. Each email contains two exercise videos and one education video. The email also includes the course work for each week and asks participants to respond if they have perceived any incidents or adverse effects during the programme.

6. Where:
As MSGHS online intervention is provided fully online via pre-recoded material and automated delivered, participants can choose where and when they want to complete the intervention each week.

7. When and How Much:
Participants complete a minimum of the two exercise videos each week, lasting approximately 35- 45 minutes. They also watch the education video lasting approximately 30 -40 minutes and then have approximately 30 minutes of course week to complete each week. The participants can choose to complete any part of the intervention at a time that suits them during the week.

8. Tailoring:
Each exercise is demonstrated and a regression and progression option are provided so individuals could choose on the day which level of the exercise they want to do. They are encouraged to complete the whole video in one go, but can pause and rest as many times as they need.
They are encouraged to complete the two exercise videos and reassured that they can repeat the video sessions more times through the week if they choose to. The course work which they are encouraged to complete in the PDF booklet also helps to make the programme tailored.

9. Modifications:
Each exercise is demonstrated and a regression and progression option are provided so individuals could choose on the day which level of the exercise they want to do.
Intervention code [1] 329146 0
Rehabilitation
Intervention code [2] 329147 0
Lifestyle
Intervention code [3] 329148 0
Behaviour
Comparator / control treatment
Once the consent form is completed they will then be randomized into either the intervention group or the waitlist control group. The waitlist control group will be emailed a link which asks them to provide some basic demographic data (age, gender, ethnicity, and which region they live in) and will be asked to complete the outcome measures at week 0, week 7 and week 12. The control group are not asked to participate in any thing different to their normal day to day life.
After the outcome measures have been completed in week 12 the waitlist control group will be notified that they can access and complete the online MSGHS programme. The waitlist group will have the identical experience and access to the programme as the intervention group (but will not be asked to complete the outcome measures).
Control group
Active

Outcomes
Primary outcome [1] 338940 0
Physical activity self efficacy
Timepoint [1] 338940 0
Baseline, week 7 and week 12 post-baseline
Primary outcome [2] 339066 0
Self-management self-efficacy
Timepoint [2] 339066 0
Baseline, week 7 and week 12 post-baseline
Primary outcome [3] 339067 0
Self-efficacy of functional gait
Timepoint [3] 339067 0
Baseline, week 7 and week 12 post-baseline
Secondary outcome [1] 437965 0
Self-reported physical activity level
Timepoint [1] 437965 0
Baseline, week 7 and week 12 post-baseline
Secondary outcome [2] 437966 0
software usability
Timepoint [2] 437966 0
Week 12 post-baseline
Secondary outcome [3] 438461 0
Self-reported physical activity level
Timepoint [3] 438461 0
Baseline, week 7 and week 12 post-baseline

Eligibility
Key inclusion criteria
• Men and women nationwide between the ages of 18 and 70 years
• Have a diagnosis of MS
• If they have been assessed using the Expanded Disability Status Scale (EDSS) they need to have a score between 0 – 4 (which means participants would have mild disability and be able to walk unaided)
• Score “no” to all questions on the Physical Activity Readiness Questionnaire. If a “yes” was scored on the first question, they can seek medical approval from their GP. They will not be considered if they scored “yes” on any of the other questions.
• Score 3 or less on the Patient-Determined Disease Steps questionnaire
• Able to get on and off the ground independently.
• Have access to the internet
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study for the following reasons:
• If they state they are not able to follow a remote video lead exercise programme
• If they have had a relapse within the last 3 months
• If they are not able to access the internet on a twice-weekly basis to watch the education and exercise sessions
• If they have previously been treated clinically by Gilly Davy or already participated in the MSGHS programme
• If they have heart disease, high blood pressure, any respiratory condition (mild asthma excluded), any illness, infection or injury that prevents them from participating in an exercise programme.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator, randomly numbers from 1 –35 allocation via a odd/even number to intervention or control.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2024
Date of last participant enrolment
Anticipated
Actual
31/07/2024
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
35
Accrual to date
Final
35
Recruitment outside Australia
Country [1] 26475 0
New Zealand
State/province [1] 26475 0

Funding & Sponsors
Funding source category [1] 317063 0
Charities/Societies/Foundations
Name [1] 317063 0
New Zealand Multiple Sclerosis Research Trust
Country [1] 317063 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 319330 0
None
Name [1] 319330 0
none
Address [1] 319330 0
Country [1] 319330 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315812 0
Auckland University of Technology Ethics Committee
Ethics committee address [1] 315812 0
Ethics committee country [1] 315812 0
New Zealand
Date submitted for ethics approval [1] 315812 0
24/01/2024
Approval date [1] 315812 0
28/05/2024
Ethics approval number [1] 315812 0
24/7

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

Contacts
Principal investigator
Name 135882 0
Mrs Gillian Davy
Address 135882 0
MS Get a Head Start, PO Box 79242, Royal Heights, Auckland 0656
Country 135882 0
New Zealand
Phone 135882 0
+64220440295
Fax 135882 0
Email 135882 0
gilly@ms-ghs.com
Contact person for public queries
Name 135883 0
Gillian Davy
Address 135883 0
MS Get a Head Start, PO Box 79242, Royal Heights, Auckland 0656
Country 135883 0
New Zealand
Phone 135883 0
+64220440295
Fax 135883 0
Email 135883 0
gilly@ms-ghs.com
Contact person for scientific queries
Name 135884 0
Gillian Davy
Address 135884 0
MS Get a Head Start, PO Box 79242, Royal Heights, Auckland 0656
Country 135884 0
New Zealand
Phone 135884 0
+64220440295
Fax 135884 0
Email 135884 0
gilly@ms-ghs.com

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


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.