Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001070426
Ethics application status
Approved
Date submitted
29/07/2016
Date registered
10/08/2016
Date last updated
10/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Test a new physiotherapy intervention to encourage people with multiple sclerosis to do more physical activity
Scientific title
Developing an intervention to promote physical activity engagement for people with multiple sclerosis living in rural settings: a feasibility study
Secondary ID [1] 289787 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 299786 0
Condition category
Condition code
Neurological 299622 299622 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 299655 299655 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Web-based Physiotherapy (WBP) and Blue prescription (BP) combination group: The 12 weeks of WBP will be delivered via a website designed and evaluated for people with multiple sclerosis (pwMS), containing a library of over 200 exercises, each exercise page consists of a video clip, audio, and text description of each exercise and a timer. Some local NZ registered physiotherapists will have one face-to-face visit (one hour) with each participant. Based on this first visit, exercise goals with the participant will be agreed and an individualised exercise programme prescribed using the web-based resource. Participants will be asked to complete a digital diary of exercise participation via the internet, available for remote viewing by the physiotherapist who can alter the patient's programme, dependent on progress, and monitor adherence and adverse events. After 12 weeks of WBP, participants will then receive the BP approach for 12 weeks. Participants will be have given a “Zoom visit” for 30 minutes, Zoom is similar to Skype but has been found to be more user friendly and require less broadband, by the same physiotherapist and, using the technique of motivational interviewing, together decide on a programme of physical activity (the participant chooses a physical activity they would like to do), how often and for how long. The physiotherapist will conduct a second “Zoom visit” approximately two weeks later, providing further advice or information. In the third “Zoom visit” (12 weeks later), the physiotherapist will ask the participant to identify any barriers to ongoing physical activity participation, encouraging the participant to problem-solve to maintain engagement. During this 12 week period, the therapist and the participant will also be in contact via telephone, email or text message to enable the physiotherapist to support the participant’s engagement in physical activity. Also, the WBP website will be accessible for the participant to use until the follow-up session (one year after baseline). The control group will be asked to complete all the five questionnaires and send them to research assistance at baseline then they have to wait for six months. Within this six-month they will receive another same questionnaire packs in the weeks 12 and 24. Then,
Each participants’ diary on the WBP website (in WBP and BP combination group) will be used to address three items. Firstly, the number of days participants use the diary will be assumed to be an indicator of participation. Secondly, participants will report difficulties encountered on the WBP website diary as well as in their emails, text messages, emails or telephone calls. Thirdly, participants will record on the WBP site when the complete each exercise, this will be taken as their physical activity.
Intervention code [1] 295454 0
Rehabilitation
Intervention code [2] 295455 0
Behaviour
Intervention code [3] 295479 0
Treatment: Other
Comparator / control treatment
The control group will be asked to complete all the five questionnaires and send them to research assistant at baseline then they have to wait for six months. In the waiting time, they will have their usual activities. Within this six-month they will receive the same questionnaire packs in weeks 12 and 24. Then, the control group will receive the same interventions as the experimental group. Their next assessments will be in weeks 36 and 48.
Control group
Active

Outcomes
Primary outcome [1] 299092 0
1. Qualitative evaluation:(composite primary outcome)
To explore participants’ perceptions of the combined interventions, outcome measures, and adverse events, semi-structured, in-depth interviews will be held once, via a Zoom meeting, at the completion of the interventions. The interviews will be recorded by Zoom application facilities and then transcribed word for word. Pain, muscle soreness, and new relapse will be considered as adverse reactions. The pain and muscle soreness will be assessed by registered physiotherapists and their reports will be used in this respect. New relapse will be acceptable if the participants' GPs report it.
Timepoint [1] 299092 0
It will be after the end of week 24.
Primary outcome [2] 299119 0
2. Diary:
Each participants’ diary on the WBP website (in WBP and BP combination group) will be used to address their participation. the number of days participants use the diary will be assumed to be an indicator of participation.
Timepoint [2] 299119 0
It will be checked every week until 12 months post-commencement of intervention.
Primary outcome [3] 299120 0
3. Completion
Completion and attrition ratios can be assumed as good indicators to evaluate the acceptability and feasibility. The participants will be assumed as a “complete case” if they finish 12 weeks each of their both interventions.
Timepoint [3] 299120 0
It will be assessed after the end of week 24.
Secondary outcome [1] 326120 0
Multiple Sclerosis Impact Scale 29 (MSIS-29) V2: evaluates the quality of life in multiple sclerosis.
Timepoint [1] 326120 0
1) Baseline, one week before interventions, 2) after 12 weeks, 3) after 24 weeks 4) 6-month follow-up ( one year after baseline). The control group will have five evaluation sessions: 1) Baseline, 2) After 12 weeks, 3) After 24 weeks, 4) After36 weeks (WBP part of their intervention), and 5) at the ends of their interventions at 48 weeks (after BP part of their intervention).
Secondary outcome [2] 326235 0
Modified Fatigue Impact Scale (MFIS): assesses fatigue.
Timepoint [2] 326235 0
1) Baseline, one week before interventions, 2) after 12 weeks, 3) after 24 weeks 4) 6-month follow-up ( one year after baseline). The control group will have five evaluation sessions: 1) Baseline, 2) After 12 weeks, 3) After 24 weeks, 4) After36 weeks (WBP part of their intervention), and 5) at the ends of their interventions at 48 weeks (after BP part of their intervention).
Secondary outcome [3] 326236 0
Exercise Self-efficacy Scale (EXSE): estimates the effect of the interventions on exercise and physical activity self-efficacy.
Timepoint [3] 326236 0
1) Baseline, one week before interventions, 2) after 12 weeks, 3) after 24 weeks 4) 6-month follow-up ( one year after baseline). The control group will have five evaluation sessions: 1) Baseline, 2) After 12 weeks, 3) After 24 weeks, 4) After36 weeks (WBP part of their intervention), and 5) at the ends of their interventions at 48 weeks (after BP part of their intervention)
Secondary outcome [4] 326237 0
Hospital Anxiety and Depression Scale (HADS):(composite secondary outcome)
evaluates the level of depression and anxiety in people with multiple sclerosis
Timepoint [4] 326237 0
1) Baseline, one week before interventions, 2) after 12 weeks, 3) after 24 weeks 4) 6-month follow-up ( one year after baseline). The control group will have five evaluation sessions: 1) Baseline, 2) After 12 weeks, 3) After 24 weeks, 4) After36 weeks (WBP part of their intervention), and 5) at the ends of their interventions at 48 weeks (after BP part of their intervention)
Secondary outcome [5] 326238 0
The Godin leisure-time Exercise Questionnaire (GLTEQ): measures physical activity participation.
Timepoint [5] 326238 0
1) Baseline, one week before interventions, 2) after 12 weeks, 3) after 24 weeks 4) 6-month follow-up ( one year after baseline). The control group will have five evaluation sessions: 1) Baseline, 2) After 12 weeks, 3) After 24 weeks, 4) After36 weeks (WBP part of their intervention), and 5) at the ends of their interventions at 48 weeks (after BP part of their intervention)
Secondary outcome [6] 326397 0
Diary (primary outcome)
participants will report difficulties encountered on the WBP website diary as well as in their emails, text messages, emails or telephone calls.
Timepoint [6] 326397 0
It will be checked every week until 12 months post-commencement of intervention.
Secondary outcome [7] 326398 0
Diary (primary outcome)
participants will record on the WBP site when the complete each exercise, this will be taken as their physical activity.
Timepoint [7] 326398 0
It will be checked every week until 12 months post-commencement of intervention.
Secondary outcome [8] 326567 0
attrition ratios
Timepoint [8] 326567 0
if some participants will not participate in the 24-week assessment, they pull out from the calculation. A completion level of greater than 95% will indicate the high feasibility/acceptability and between 80 to 95% an acceptable one reasonable feasibility/acceptability.

Eligibility
Key inclusion criteria
a diagnosis of MS of any type, aged 18-85 years, presenting with a moderate to high level of disability based on EDSS scale. Participants will be required to have computer and internet access (compatible with Zoom and the WBP) and have basic computer skills (or have a person who can help them to use a computer). Participants will live in a rural area as determined by their residential postal address.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current or recent disease relapse (< 3 months), currently participating in regular exercise or physical activity programmes, receiving regular rehabilitation or participating in other clinical trials, and the presence of co-morbidities, such as cardiac, orthopaedic or neurological conditions that prevent them from taking part in physical activity. The Physical Activity Readiness Questionnaire(PARQ) will be administered to assess the latter criteria and any positive answer in participant’s PARQ will check with their GPs to omit any potential harm.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A thematic framework analysis will be used to analyse participants’ interview data. After familiarisation with the data, a coding and charting process will be used to identify potential patterns and associations in the data. Diary data will be analysed in two ways. First, the number of days that the intervention group participants used the diary. Second, all diary entries will be read carefully to identify difficulties encountered and adverse events as a result of participating in the programme. These findings will be reported narratively. The normality of continuous data (quantitative parts) will be tested and confirmed by the Kolmogorov-Smirnov test. Descriptive statistics, such as standard deviation, average, and range will be reported. Repeated measurement analysis will be used to investigate the between-group effects on the quantitative outcome measures with the simultaneous effect of time and group variables (interaction effect) analysed. The effect of other factors such as gender (male-female), age, and EDSS as confounding factors will be entered into the model. The significance level will be considered to be p< 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/08/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 8059 0
New Zealand
State/province [1] 8059 0
Otago
Country [2] 8060 0
New Zealand
State/province [2] 8060 0
Southland

Funding & Sponsors
Funding source category [1] 294170 0
University
Name [1] 294170 0
University of Otago
Country [1] 294170 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
325 Great King
Dunedin central, 9016
Country
New Zealand
Secondary sponsor category [1] 293002 0
None
Name [1] 293002 0
Address [1] 293002 0
Country [1] 293002 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295578 0
The University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 295578 0
Ethics committee country [1] 295578 0
New Zealand
Date submitted for ethics approval [1] 295578 0
14/06/2016
Approval date [1] 295578 0
07/07/2016
Ethics approval number [1] 295578 0
H16/078

Summary
Brief summary
This study aims to increase physical activity in people with MS living in rural settings. According to the Transtheoretical Theory (Hayden 2014), behaviour change is a process that occurs in stages. Therefore, the Web-Based Physio (WBP) intervention may help the person to progress from the precontemplation or contemplation stages to the action stage (in other words get the person started in an exercise programme in their homes). This intervention can then be followed with the Blue Prescription intervention which might encourage the person to move through the Action stage to the Maintenance stage.
This feasibility study will be a wait list randomised mixed method design. Twenty participants will be recruited and will be divided into two groups, experimental and control. Each participant in the experimental group will receive the WBP intervention for 12 weeks followed by the BP intervention for 12 weeks. Participants will be assessed at baseline, after the first 12 weeks and after the second 12 weeks. One follow-up evaluation will be conducted at 6 months after the combined intervention. People in the control group will wait for six months and then commence the interventions
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 978 978 0 0
/AnzctrAttachments/371190-Final Approval Letter.pdf
Attachments [2] 979 979 0 0
/AnzctrAttachments/371190-Feasibility study protocol Plan D, Draft 5.docx

Contacts
Principal investigator
Name 67818 0
Dr Catherine M. Smith
Address 67818 0
School of physiotherapy, University of Otago
325 Great king
Dunedin Central, 9016
Country 67818 0
New Zealand
Phone 67818 0
+643479 7473
Fax 67818 0
Email 67818 0
[email protected]
Contact person for public queries
Name 67819 0
Mr Bahram Sangelaji
Address 67819 0
School of physiotherapy, University of Otago
325 Great king
Dunedin Central, 9016
Country 67819 0
New Zealand
Phone 67819 0
+6434799619
Fax 67819 0
Email 67819 0
[email protected]
Contact person for scientific queries
Name 67820 0
Mr Bahram Sangelaji
Address 67820 0
School of physiotherapy, University of Otago
325 Great king
Dunedin Central, 9016
Country 67820 0
New Zealand
Phone 67820 0
+6434799619
Fax 67820 0
Email 67820 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23452Clinical study reportSangelaji, B. (2018). Developing an intervention to promote physical activity engagement for people with multiple sclerosis living in rural settings (Thesis, Doctor of Philosophy). University of Otago. Retrieved from http://hdl.handle.net/10523/8371https://ourarchive.otago.ac.nz/handle/10523/8371[email protected]

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.