Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001266651
Ethics application status
Approved
Date submitted
1/11/2023
Date registered
6/12/2023
Date last updated
6/12/2023
Date data sharing statement initially provided
6/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Walking without Pain: Piloting a digital program for people 50 years and over experiencing chronic low back pain
Scientific title
Walking without Pain: Piloting a digital physical activity intervention and online psychological program targeting daily walk time in people 50 years and over experiencing chronic low back pain
Secondary ID [1] 310660 0
None
Universal Trial Number (UTN)
Trial acronym
WWoP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain (CLBP) 331558 0
Condition category
Condition code
Musculoskeletal 328297 328297 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name:
Walking without Pain

What materials:
Participants in the intervention group will receive:
• The Pain Course (eCentreClinic) – an online psychological program designed for people managing different pain conditions. The aims of the course are to provide information about chronic pain and to share skills for managing the impact of chronic pain on daily life and emotional wellbeing.
• An Individual Walking Program (IWP) – a digitally delivered, tailored and progressive walking program targeting daily walk time.
• Physical Activity Coaching – 2-5 telehealth sessions with an Exercise Physiologist to support participants during the IWP. Sessions delivered by the Exercise Physiologist will be guided by a script.
Participants in the intervention group will be provided:
• An Actigraph (GT9X) - a wrist-worn physical activity monitoring device to support them during the Individual Walking Program (IWP).

What procedures:
Pain Course:
• Participants will be onboarded (pre-arranged appointment) remotely to the Pain Course by the Clinical Psychologist, who is a member of the research team.
• The Pain Course will be delivered by the eCentre Clinic and will run for 8 weeks with lessons in weeks 1, 2, 4, 5, & 7. Total time involvement is expected to amount to 4hrs/week with optional weekly support (pre-arranged) via telephone or private messaging platform with the Clinical Psychologist.

Content summary:

The Pain Course is a validated Internet-delivered pain management program that is based on the principles of cognitive-behavioral therapy and transdiagnostic psychological intervention. It consists of 5 modules, delivered as a slide show, and 5 downloadable homework assignments to assist participants in learning and applying the skills described in the lessons. Detailed case stories and examples are included throughout all materials. Additional resources on related topics (eg, managing sleep, problem solving) are also available. Materials are released systematically over 8 weeks. Brief module contents:

a. Week 1 - Psychoeducation about chronic pain and symptoms of anxiety and depression. Introduction of a CBT model incorporating pain, physical symptoms, thoughts, and behaviours.
b. Week 2 and 3 - Education about the importance of managing thoughts to help manage pain. Thought monitoring and cognitive challenging.
c. Week 4 - Physical symptoms of anxiety and depression and their relationship to managing the impact of chronic pain. Controlled breathing and activity scheduling.
d. Week 5 and 6 - Behavioural symptoms of anxiety, depression and chronic pain. Activity pacing and a guide for gradual increase in activity.
e. Week 7 and 8 - Information about lapses in chronic pain, depression and anxiety. Relapse prevention planning and goal-setting.

Mode of training: materials are presented as slide shows consisting of static text and images. These are also available as PDF downloads.

Duration of onboarding: approximately 10 minutes.

Adherence: the eCentreClinic website records % completion for each module.

Individual Walking Program (IWP):
Participants will:
• Wear a waist-worn activity monitoring device (McRoberts Monitor) for 7 days at baseline to determine baseline physical activity levels.
• Be onboarded remotely (pre-arranged appointment) to the IWP and wrist-worn physical activity monitoring device in week 3.
• Receive REDCap delivered email or text message reminders to charge the device daily.
• Receive tailored daily step goals sent weekly via REDCap and delivered as an email or text message.

Participants will be asked to wear an activity monitor for 7 days at baseline. The device will record their daily steps. An average will be taken from the days recorded to determine their baseline activity levels.

Participants will receive 2-5 telehealth physical activity coaching sessions with a member of the research team. These sessions are scheduled to take place at week 3, 6, 8, 10 and 12 of the 14-week intervention period to coincide with the Walking Program (12-weeks) and Pain Course (8-weeks).

During these coaching sessions, participants will be supported with their physical activity behaviour – daily walking. This will include reviewing individual effort/adherence (number of daily walks/week, daily steps), individual tailoring, addressing barriers etc. Participants will be loaned a wrist worn physical activity monitoring device throughout the intervention in order to monitor their own daily step count. When the intervention is complete, these devices will be returned and the data extracted (daily walk time, steps).

Physical Activity Coaching:
• Participants will be offered 5 physical activity coaching sessions (pre-arranged appointments).
• 2 of the 5 sessions are essential (week 3 and 6). The first (week 3) coincides with the onboarding to the IWP and the Actigraph GT9X and is expected to take 45 minutes. The second (week 6), is estimated to take 30 minutes and aligns with Pain Course lessons about activity scheduling, activity pacing, and graded exposure.
• The remaining three sessions (week 8, 10, 12) are for review/feedback and are optional. We expect they will take participants 10 minutes each.

Session 1 week 3 (45 minutes): the purpose of this contact is to onboard the participant to the IWP and activity monitoring device (wrist worn). Encourage goal setting and action planning, introduce habit formation including prompts/cues.

Session 2 week 6 (30 minutes): the purpose of this contact is to review goal progress, support problem solving, discuss Pain Course lesson 3,4 (activity scheduling, activity pacing, graded exposure) in relation to their daily walking goal.

Session 3,4,5 week 8,10,12 (10 minutes): participants can opt in/out (via survey) of a review phone call (scheduled) every 2 weeks for the remainder of the IWP. The purpose of these contacts is to check in, support the participant via tailoring, problem solving, etc.

Session attendance will be monitored in the study database.

Who:
Individual Walking Program (IWP) and Physical Activity Coaching: Delivered by an Exercise Physiologist. Exercise Physiologists are university qualified allied health professionals, trained in clinical exercise interventions and behaviour change.
Pain Course: Developed by the eCentre Clinic, (a specialist research unit at Macquarie University), is an internet delivered pain management program, supported by a Clinical Psychologist.

How:
Individual Walking Program (IWP): internet delivered, tailored daily step goals sent weekly via REDCap and delivered as an email or text message.
Physical Activity Coaching: delivered via telehealth (telephone or videoconference (zoom) with or without video based on participant preference).
Pain Course: internet delivered, contact via phone or private messaging platform from Clinical Psychologist.

Where:
NeuRA and the eCentre Clinic are both located in Sydney, Australia. Participants from the intervention group and waitlist control group will attend NeuRA once to complete a baseline assessment.
The intervention itself is completed remotely. Intervention participants do not need to attend NeuRA or the eCentre Clinic during the intervention or follow-up period. Based on the inclusion criteria, participants will reside within the Sydney Metropolitan area.

When and how much:

The intervention period will be 14 weeks long with a 6-month follow-up period calculated from the the baseline. Participants will not be required to perform any study related tasks between the 15-week timepoint and 6-month timepoint.

Individual Walking Program (IWP): starts in week 3 and is 12-weeks in duration. Participants receive a daily step goal calculated from their baseline activity levels, and is gradually increased by 10% each week, with the overall aim of 7,000 – 10,000 steps per day by the end of the 12-weeks.
Physical Activity Coaching: 2-5 sessions, with 2 of these sessions required (week 3 and 6). The required sessions coincide with the IWP, with session 1 and 2 estimated to take 45 minutes and 30 minutes respectively. The remaining 3 sessions (week 8, 10, 12) are optional and are estimated at 10 minutes each.
Pain Course: 8 weeks, 5 lessons, 4hrs/week, weekly optional contact (10-20 minutes)

Tailoring:
Individual Walking Program (IWP): At baseline, participants will receive a waist-worn physical activity monitoring device (McRoberts Monitor) via post and be asked to wear this for 7 days, returning it via reply paid envelope. The data from the device will be analysed and used to tailor the IWP. Participants will receive a daily step target based on their baseline activity levels. This step target will gradually increase by 10% (or slightly more) of their baseline daily steps each week, to ensure that at the end of the 12 weeks, their daily steps meet the target of between 7,000-10,000 steps per day. To achieve the step target, participants will be encouraged to engage in an extra exercise walk each day. This means that participants will be asked to go for an exercise walk of approximately 4 minutes (based on step count and average walking speed in week 1), gradually building up to a walk of a maximum of 48 minutes over the 12 weeks.
Physical Activity Coaching: The sessions will encourage positive behaviour change through 1) conversation guided by motivational interviewing (MI), and 2) behaviour change techniques (BCTs) such as goals and planning, feedback and monitoring, shaping knowledge, habit formation (associations, repetition and substitution). The Exercise Physiologist delivering these sessions will refer to a script to guide the conversation, however as it is guided by MI, coaching is flexible and therefore not linear.
Pain Course: The Pain Course comes with a recommended timeline (5 lessons across week 1, 2, 4, 5, 7). Participants are encouraged to read all of the materials particularly focusing on the materials that are most relevant to them. A clinical psychologist from the eCentre Clinic will contact participants throughout the Pain Course in an optional guided arrangement. The clinical psychologist will contact participants at the start of the Pain Course to orient them to the course and find out about participant contact preferences. Some participants may choose weekly contact, while others may choose to contact the clinical psychologist as needed, or to be contacted less frequently e.g., at the mid-point, and the end, of the Pain Course.
Intervention code [1] 327095 0
Rehabilitation
Intervention code [2] 327096 0
Lifestyle
Intervention code [3] 327097 0
Behaviour
Comparator / control treatment
Participants in the waitlist control group will receive usual care. This may include, but is not limited to, components such as general health promotion education programs. However, no intervention will be provided by the research team. Following the 6-month follow-up period waitlist control participants will be enrolled in the Pain Course. Additionally, waitlist control participants will be provided with details of the Heart Foundations Personal Walking Plan.
Control group
Active

Outcomes
Primary outcome [1] 336191 0
Daily walk time
Timepoint [1] 336191 0
Baseline, 15-weeks post baseline, 6-months post baseline .
Secondary outcome [1] 427265 0
Quality of life
Timepoint [1] 427265 0
Baseline, 15-weeks post baseline
Secondary outcome [2] 427266 0
Mental health and well-being
Timepoint [2] 427266 0
Baseline, 15-weeks post baseline
Secondary outcome [3] 427267 0
Mental health and well-being - pain self-efficacy (composite measure) i.e., an individual’s belief in their ability to complete activities with ongoing pain
Timepoint [3] 427267 0
Baseline, 15-weeks post baseline
Secondary outcome [4] 427268 0
Mental health and well-being – depression screener
Timepoint [4] 427268 0
Baseline, 5 weeks post intervention commencement, 9 weeks post intervention commencement (1 week post Pain Course completion), 15-weeks post baseline, 6-months post baseline.
Secondary outcome [5] 428436 0
Mental health and well-being - Brief screening tool for generalised anxiety
Timepoint [5] 428436 0
Baseline, 5 weeks post intervention commencement, 9 weeks post intervention commencement (1 week post Pain Course completion), 15-weeks post baseline, 6-months post baseline.
Secondary outcome [6] 428437 0
Mental health and well-being - (composite measure) location, severity, and duration of a person's pain as well as the level of interference associated with pain
Timepoint [6] 428437 0
Baseline, 5 weeks post intervention commencement, 9 weeks post intervention commencement (1 week post Pain Course completion), 15-weeks post baseline, 6-months post baseline.
Secondary outcome [7] 428438 0
Mental health and well-being - (composite measure) impact of pain on an individual’s functional health and wellbeing
Timepoint [7] 428438 0
Baseline, 5 weeks post intervention commencement, 9 weeks post intervention commencement (1 week post Pain Course completion), 15-weeks post baseline, 6-months post baseline.
Secondary outcome [8] 428439 0
Mental health and well-being - (composite measure) self-reported measure of pain, monitor pain over time
Timepoint [8] 428439 0
Baseline, 15-weeks post baseline
Secondary outcome [9] 428440 0
Health Behaviour - individual belief/confidence in their capacity to exercise/continue exercise
Timepoint [9] 428440 0
Baseline, 9 weeks post intervention commencement (1 week post Pain Course completion), 15-weeks post baseline
Secondary outcome [10] 428441 0
Health Behaviour - (composite measure) evaluate incidental and planned exercise during a week
Timepoint [10] 428441 0
Baseline, 15-weeks post baseline, 6-months post baseline .
Secondary outcome [11] 428443 0
Health Behaviour - the automaticity of a behaviour, in this case daily walking
Timepoint [11] 428443 0
Baseline, 15-weeks post baseline
Secondary outcome [12] 428444 0
Falls
Timepoint [12] 428444 0
6-months post baseline questionnaire.

Eligibility
Key inclusion criteria
- Aged 50 years or older (self-reported)
- Have had chronic low back pain for 3 months or longer (self-reported)
- Living independently in the community (self-reported)
- Able to walk for 100 metres without stopping OR 300 metres with stopping (with or without walking aid) (self-reported)
- Able to communicate (verbal and written) and understand English proficiently (self-reported)
- Access to a computer or tablet and internet (self-reported)
- Reside within the Sydney Metropolitan area (self-reported)
- Willing to participate in the study and able to provide informed consent
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Already achieving the physical activity guidelines of 150 minutes of moderate-intensity or 75 minutes of high-intensity, or an equal combination of, aerobic physical activity per week (mode: walking) (self-reported)
- Medical conditions that preclude exercise participation (self-reported) such as:
- Progressive neurological disease such as Parkinson’s disease
- Uncontrolled medical conditions such as diabetes, hypertension, angina
(Addressed in screening questionnaire and confirmed via telephone communication prior to eligibility status)
- Major cognitive impairment (screened using a Short Portable Mental Status Questionnaire (SPMSQ) score <8)
- Visual and/or hearing impairment that would impede the adequate operation of electronic devices (self-reported)
- Imminent risk of suicide or unable to keep themselves safe (screened using a Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 15 or answering “Yes” to the suicidality question, they will be referred to the eCentreClinic for a psychological risk assessment prior to confirmation of eligibility status)
- Does not have access to a computer or tablet and the internet
- Unable to read and understand English
- Have contraindications that will prevent assessment using Magnetic Resonance Imaging (MRI) (self-reported), such as:
- Protheses and implants (e.g., pacemakers, internal hearing devices, vascular clips),
- Presence of metallic foreign body (e.g. small metal fragments in the eye),
- Conductors (e.g., wires, metallic surgical)

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)
Eligible, consenting individuals will be randomly allocated to the intervention (n= 20) or waitlist control group (n=20). Participants will be randomly allocated after they have completed the baseline assessment. Due to the nature of the intervention, participants cannot be blinded.

Research staff performing the assessments will be blinded to the group allocation.

Follow up calls will be completed by a blinded research assistant

Participants will be randomly allocated after they have completed the baseline assessment.

Allocation will be performed using a custom randomisation program by an investigator not involved in assessments or delivery of the intervention.

People living in the same household will be treated as one unit to avoid contamination.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/12/2023
Actual
Date of last participant enrolment
Anticipated
24/01/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314879 0
Other Collaborative groups
Name [1] 314879 0
SPHERE Neuroscience, Mental health and Addictions Clinical Academic Group
Country [1] 314879 0
Australia
Funding source category [2] 314953 0
Government body
Name [2] 314953 0
NHMRC Investigator Grant (Prof Delbaere)
Country [2] 314953 0
Australia
Funding source category [3] 315363 0
Other
Name [3] 315363 0
Newman Family Foundation
Country [3] 315363 0
United States of America
Primary sponsor type
Other
Name
Neuroscience Research Australia (NeuRA)
Address
139 Barker Street Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 316953 0
None
Name [1] 316953 0
Address [1] 316953 0
Country [1] 316953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313877 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 313877 0
UNSW Sydney High St Kensington NSW 2052
Ethics committee country [1] 313877 0
Australia
Date submitted for ethics approval [1] 313877 0
Approval date [1] 313877 0
26/09/2023
Ethics approval number [1] 313877 0
HC230496

Summary
Brief summary
This project aims to gain insight into the effect of a digital physical activity intervention (tailored walking program and physical activity coaching) and an online psychological program (Pain Course) in people 50 years and over living with chronic low back pain (CLBP).
Does a tailored walking intervention combined with an online psychological program improve physical activity levels measured by daily walk time in people 50 years and older with chronic low back pain (CLBP)?
We hypothesise that our intervention will lead to an increase in physical activity levels (daily walk time) over 6-months.
This project is a two-arm, single-blinded, interventional, randomised control trial with a 14-week intervention period and a 6-month follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129638 0
Prof Kim Delbaere
Address 129638 0
Neuroscience Research Australia (NeuRA) 139 Barker Street, Randwick NSW 2031
Country 129638 0
Australia
Phone 129638 0
+61 02 9399 1066
Fax 129638 0
Email 129638 0
k.delbaere@neura.edu.au
Contact person for public queries
Name 129639 0
Miss Amy Perram
Address 129639 0
Neuroscience Research Australia (NeuRA) 139 Barker Street, Randwick NSW 2031
Country 129639 0
Australia
Phone 129639 0
+61 02 9399 1123
Fax 129639 0
Email 129639 0
a.perram@neura.edu.au
Contact person for scientific queries
Name 129640 0
Dr Kim S van Schooten
Address 129640 0
Neuroscience Research Australia (NeuRA) 139 Barker Street, Randwick NSW 2031
Country 129640 0
Australia
Phone 129640 0
+61 02 9399 1087
Fax 129640 0
Email 129640 0
k.vanschooten@neura.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All registered data available. After publication of main results. Shared in a format that will not identify the individual (re-identifiable format, identifiers such as name, address, date of birth will be replaced with a unique code).
When will data be available (start and end dates)?
Beginning directly following main results publication and ending 15 years later (data retention period)
Available to whom?
Approved research investigators (must provide a methodologically sound proposal).
Available by emailing the data custodian (k.vanschooten@neura.edu.au)
Available for what types of analyses?
Consent is obtained for the research team to share or use the information collected in future research that will be specific to the aims of this research.
How or where can data be obtained?
Information collected in an electronic format, and or audio/video recording will be stored on a password-protected server at Neuroscience Research Australia and/or the University of New South Wales, only accessible to the approved research investigators. Available by emailing the data custodian (k.vanschooten@neura.edu.au).


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.