Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001276741
Ethics application status
Approved
Date submitted
16/09/2022
Date registered
29/09/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
29/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing Safety and Treatment Efficacy of Running On Intervertebral Discs (ASTEROID)
Scientific title
Effects of progressive cardiovascular exercise on intervertebral disc health, pain intensity and disability in adults with chronic low back pain
Secondary ID [1] 307986 0
None
Universal Trial Number (UTN)
Trial acronym
ASTEROID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 327649 0
Condition category
Condition code
Musculoskeletal 324736 324736 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 324737 324737 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three unsupervised community-based 30-minute exercise training sessions per week for 12 weeks prescribed by an accredited exercise physiologist from the research team. The setting in where the intervention will be performed is outdoors within the participants local community (e.g. walking/running track, local sports oval). Participants will require a mobile device and the RunKeeper app (ASICS Runner App, Inc.) to guide run/walk intervals and track exercise training data (i.e. speed, duration). As the intervention will be performed in the community, no additional equipment will be required. Exercise training sessions will be individualised based on participant capacity and rating of perceived exertion determined during a 30-minute initial assessment. Exercise training sessions will consist of a 5-minute general warm up followed by interval-based locomotive cardiovascular exercise training (e.g. walking or jogging) and will be progressed weekly as guided by an accredited exercise physiologist from the research team. Participants will receive educational content throughout the intervention covering how to safely exercise and avoid injury. Participants will receive educational materials through an online questionnaire database (RedCap), which is anonymously linked to each participant. Educational content will be provided to the participants fortnightly over the first eight weeks of the intervention. Educational material will cover the following topics: ideal running speed, footwear selection, benefits of running/physical activity and dealing with setbacks. The education materials will be designed specifically for the study by accredited exercise physiologists, with the aim of increasing adherence and minimising attrition. Educational materials are expected to take less than five minutes to review. Weekly 15-minute video calls with a member of study team to discuss exercise training program. Weekly video calls will discuss how progress/regress the program as required, adherence, any adverse effects and any other concerns or questions participants may have about the program or their low back pain. Adherence to the educational content will be monitored during the weekly zoom meeting by asking the participant: 'Have you read the educational content RE: 'X'. Can I answer any questions you may have?'

The cardiovascular exercise program will consist of short running intervals interspersed with rest periods of walking. The rest periods between running intervals start at 115-120 seconds (depending on start point) and decrease by 15-25 seconds at each stage down to a possible minimum of 15 seconds. This type of interval-based training is an effective way to increase running capacity in untrained novice runners and is recommended following hip and lower limb injuries as a way to safely return to running. Participants enter the interval training program at stage one, two or three as determined by their performance on a 2-minute run test at the initial physical assessment. During the test participants will be instructed to run at a slow to moderate pace for as long as they are comfortable up to a maximum of two minutes. A slow or moderate running pace will be defined as less 10km per hour (6 mins/km). This is likely to translate to a running speed that is optimal to influence the intervertebral discs. Participants who can jog comfortably for: 1) 0-44 seconds will start at stage one of the program; 2) 45-89 seconds will start at stage two of the program; and 3) 90-120 seconds will start at stage three of the program. If preferred, participants also have the option to choose their starting point (stage one, two or three) in consultation with the accredited exercise physiologist irrespective of the test results. Each stage will consist of 6-10 repeats (participant to choose) with the running interval duration starting at 15-45 seconds (depending on start point) and increasing by 15 seconds each stage up to a maximum of 210 seconds. For example, at stage two, participants can select to complete between six and 10 repeats of 30 seconds jogging. This accounts for the daily fluctuations in pain intensity observed in up to 35% of individuals with chronic low back pain while promoting self-efficacy through autonomy and shared decision making. Once participants can complete the upper repeat range in each week, they progress to the next stage the following week. To reduce risk of injury due to the rate of progression, participants can only increase one stage per week and must complete at least two sessions per week before progressing to the following stage. The increase in average running time per week is greater over the first six weeks (20-100%) due to a conservatively chosen starting point (i.e. 1.5 mins total jogging time per session at stage one) before levelling off to increases of approximately 10-15% thereafter. Importantly, in novice runners there is no difference in the prevalence of running related injuries between training programs that adhere to a strict 10% weekly increase and those that include greater weekly progressions up to 50%. If participants reach the final stage before the end of the intervention, they will remain at this stage for the remaining weeks. Throughout the intervention participants will be advised to jog at a slow to moderate pace which corresponds with velocities thought to have a positive stimulus on the intervertebral disc, with higher running speeds correlated with poorer disc health outcomes. In collaboration with the accredited exercise physiologist, participants will have the option to regress to an earlier stage of the interval program if deemed necessary (e.g. significantly increased low back pain, other injury/soreness, following periods of poor adherence). Sessions recorded in the RunKeeper app will be reviewed by an accredited exercise physiologist. Subjective recall of completed sessions will also be recorded during the weekly zoom meetings.
Intervention code [1] 324442 0
Rehabilitation
Intervention code [2] 324467 0
Treatment: Other
Comparator / control treatment
Participants will be asked to manage their low back pain per usual (e.g. general practitioner management, over-the-counter pharmacotherapy). No intervention will be provided during 12-week follow-up. Following completion of the study, these participants will be offered a similar exercise training program and 1-on-1 consultation with an accredited exercise physiologist from the research team.
Control group
Active

Outcomes
Primary outcome [1] 332556 0
lumbar intervertebral disc T2-time (magnetic resonance imaging)
Timepoint [1] 332556 0
Baseline, 6-week post-baseline, 12-week post-baseline (primary endpoint)
Primary outcome [2] 332557 0
Low back pain intensity (visual analogue scale)
Timepoint [2] 332557 0
Baseline, 6-week post-baseline, 12-week post-baseline (primary endpoint)
Primary outcome [3] 332558 0
Disability (Oswestry Disability Index)
Timepoint [3] 332558 0
Baseline, 6-week post-baseline, 12-week post-baseline (primary endpoint)
Secondary outcome [1] 413897 0
Lumbar intervertebral disc height and volume (magnetic resonance imaging)
Timepoint [1] 413897 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [2] 413898 0
Paraspinal muscle (multifidus, erector spinae, psoas major, quadratus lumborum) volume and size (magnetic resonance imaging)
Timepoint [2] 413898 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [3] 413899 0
Paraspinal muscle (multifidus, erector spinae, psoas major, quadratus lumborum) fat fraction (magnetic resonance imaging)
Timepoint [3] 413899 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [4] 413900 0
Vertebral body (multifidus, erector spinae, psoas major, quadratus lumborum) fat fraction (magnetic resonance imaging)
Timepoint [4] 413900 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [5] 413902 0
Sleep quality (Pittsburgh Sleep Quality Index)
Timepoint [5] 413902 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [6] 413903 0
Insomnia severity (Insomnia Severity Index)
Timepoint [6] 413903 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [7] 413904 0
Health-related quality of life (EQ-5D-5L)
Timepoint [7] 413904 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [8] 413905 0
Inflammatory blood markers (C-reactive protein, tumour necrosis factor alpha, interleukin-1 beta, interleukin-4, interleukin-6, interleukin-8, interleukin-12, interferon-gamma, prostaglandin E2)
Timepoint [8] 413905 0
Baseline, 12-week post-baseline
Secondary outcome [9] 413906 0
Habitual physical activity (International Physical Activity Questionnaire)
Timepoint [9] 413906 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [10] 413908 0
Recovery expectations (to measure general expectations of recovery responses) are rated from 0 to 10 points, where zero indicates no improvement and 10 indicates complete recovery. This format of question and rating scale are commonly used in the literature to measure recovery expectations)
Timepoint [10] 413908 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [11] 413909 0
Activity-specific beliefs (A 6-item questionnaire designed specifically for this study will be used to assess the beliefs of safety towards specific physical activities. Participants are asked whether they think a specific exercise/movement is safe for them. Responses to 20 common physical activities are rated on a five point Likert item from definitely no to definitely yes)
Timepoint [11] 413909 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [12] 413910 0
Kinesiophobia (Tampa Scale for Kinesiophobia)
Timepoint [12] 413910 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [13] 413911 0
Mood (Depression Anxiety and Stress Scale)
Timepoint [13] 413911 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [14] 413912 0
Pain catastrophising (Pain Catastrophising Scale)
Timepoint [14] 413912 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [15] 413913 0
Pain self-efficacy (Pain self-efficacy Questionnaire)
Timepoint [15] 413913 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [16] 413914 0
Social support (Multidimentional Scale of Perceived Social Support)
Timepoint [16] 413914 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [17] 413915 0
Adverse events (defined as medical illness, musculoskeletal injury or missed sessions due to pain and/or injury and will be classified as serious or non-serious. Serious adverse events will be any event that leads to either death, hospitalisation or a serious risk of deterioration in health. All other reported adverse events will be defined as non-serious, for example, an increase in pain or injury which causes a missed session. Adverse events will be deemed study related if considered most likely or definitely resulting from the participants involvement in the intervention or testing procedures. Possible adverse events include minor discomfort, muscle soreness or increased pain following physical baseline tests or post exercise session. Less likely adverse events include injury sustained during an exercise session, tingling or heating sensations during magnetic resonance imaging, minor pain or bruising following blood draws). Participants will be advised to contact one of the research team if they encounter an adverse event throughout the 12-week intervention. The total number of serious and non-serious adverse events will be collected via RedCap, including details on when and how the adverse event occurred and whether it was deemed study related.
Timepoint [17] 413915 0
Monitored for continuously for the duration of the 12-week intervention period
Secondary outcome [18] 414013 0
Feasibility (recruitment: [1] enrolled participants compared to total screened potential participants, [2] reasons for ineligibility or declined participation, [3] enrolment timeline, [4] efficacy of recruitment pathways [i.e. enrolled participants compared to total screened potential participants by pathway]). Outcomes will be collected during study recruitment with data captured via RedCap.
Timepoint [18] 414013 0
Upon completion of recruitment
Secondary outcome [19] 414014 0
Feasiblity (attrition: [1] number of participants available for follow-up, [2] reasons for loss to follow-up). Data on attrition will be collected by audit of study data in RedCap.
Timepoint [19] 414014 0
Upon completion of collection of follow-up data
Secondary outcome [20] 414015 0
Feasibility (adherence: [1] overall training session attendance, [2] within session training load completed). Data on adherence will be collected by accessing participant training data recorded via the RunKeeper app and transferred to RedCap on a fortnightly basis.
Timepoint [20] 414015 0
Upon completion of the 12-week intervention
Secondary outcome [21] 414016 0
Feasibility (data collection: [1] missing data, [2] reasons for missing data). Data on missingness will be collected by audit of study data in RedCap.
Timepoint [21] 414016 0
Upon completion of data collection
Secondary outcome [22] 414018 0
Acceptability will be measured with a system usability survey delivered via RedCap. Responses to 10 questions will be recorded on a scale from 1 to 5 where one represents completely disagree and five represents completely agree.
Timepoint [22] 414018 0
Upon completion of the 12-week intervention
Secondary outcome [23] 414131 0
Treatment specific expectations to the intervention (to measure expectations that the treatment will be beneficial) are rated from 0 to 10 points, where zero indicates not at all helpful and 10 indicates extremely helpful. This format of question and rating scale are commonly used in the literature to measure treatment expectations)
Timepoint [23] 414131 0
Baseline, 6-week post-baseline, 12-week post-baseline
Secondary outcome [24] 414132 0
Participant feedback will be taken during a 60-minute semi-structured interview conducted with face-to-face one of the research team.
Timepoint [24] 414132 0
Upon completion of the 12-week intervention
Secondary outcome [25] 416683 0
Feasibility (pain intensity - intervention group only). Data on pain intensity will be collected fortnightly during zoom meetings in the intervention group only to assist with assessing the feasibility of the running intervention.
Timepoint [25] 416683 0
Fortnightly for the 12-week intervention
Secondary outcome [26] 416684 0
Pressure-pain thresholds assessed at the forearms, lumbar spine and calves via digital algometry
Timepoint [26] 416684 0
Baseline, 12-weeks post-baseline
Secondary outcome [27] 416685 0
Exercise-induced hypoalgesia (via pressure-pain threshold assessement pre/post an acute exercise stimulus). The acute exercise stimulis between each pressure-pain threshold assessment will be a 3-minute isometric wall squat. A digital algometer will be used to assess pressure-pain threholds.
Timepoint [27] 416685 0
Baseline, 12-weeks post-baseline

Eligibility
Key inclusion criteria
Adults (>18 years) with non-specific (no known specific pathology) chronic (>12 weeks) low back pain (pain located between the costal margin and above the inferior gluteal folds, with or without leg pain).
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include: (a) history of spinal surgery, spine trauma (e.g. fracture or car accident), cauda equina symptoms, known structural scoliosis requiring surgical consultation, symptomatic radiculopathy (diagnosed via medical professional or leg pain greater than back pain), inflammatory spondyloarthropathies, or non musculoskeletal causes of low back pain (e.g. infection), (b) inability to communicate in English, (c) pregnancy, lactating or <1 year postnatal, (d) current or prior elite athletes (member of Australian Institute of Sport, State Institutes or Academies of Sport or the national squad of any sport), (e) any absolute contraindications for magnetic resonance imaging, (f) any absolute contraindication for exercise training, (g) participation in running or sport that involves running in the last three months (>1 session per month), (h) experienced a lower limb injury in the last six weeks, (i) deemed higher risk of adverse event due to physical activity per the Adult Pre-Exercise Screening System, (j) unable to access a smartphone with a cellular internet connection.

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)
A team member who will have no contact with participants will obtain and employ the randomisation schedule (creating sequentially numbered, opaque, sealed envelopes).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned (1:1) using block randomisation with random block lengths (between two to six per block), and stratification for sex, to either intervention or waitlist control. The randomisation schedule will be developed using the ‘blockrand’ package in R version 4.1.2 (https://www.r-project.org/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Linear mixed models with random effects (participants) and an intention-to-treat approach will be used to evaluate within- and between-group changes by time. All linear mixed models will allow for heterogeneity of variance according to study date and employ restricted maximum likelihood estimations. An a of 0.05 will be adopted for all analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2022
Actual
1/12/2022
Date of last participant enrolment
Anticipated
1/04/2023
Actual
9/02/2023
Date of last data collection
Anticipated
24/06/2023
Actual
16/05/2023
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312251 0
University
Name [1] 312251 0
Deakin University
Country [1] 312251 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gheringhap St, Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 313790 0
None
Name [1] 313790 0
Address [1] 313790 0
Country [1] 313790 0
Other collaborator category [1] 282425 0
University
Name [1] 282425 0
Hochschule für Gesundheit
Address [1] 282425 0
Gesundheitscampus 6-8, 44801, Bochum
Country [1] 282425 0
Germany
Other collaborator category [2] 282426 0
University
Name [2] 282426 0
Victoria University of Wellington
Address [2] 282426 0
Victoria University of Wellington, PO Box 600, Wellington 6140
Country [2] 282426 0
New Zealand
Other collaborator category [3] 282427 0
University
Name [3] 282427 0
Victoria University
Address [3] 282427 0
70/104 Ballarat Rd, Footscray VIC 3011
Country [3] 282427 0
Australia
Other collaborator category [4] 282428 0
Commercial sector/Industry
Name [4] 282428 0
Imaging @ Olympic Park
Address [4] 282428 0
AAMI Park, 60 Olympic Boulevard, Melbourne VIC 3004
Country [4] 282428 0
Australia
Other collaborator category [5] 282429 0
University
Name [5] 282429 0
Central Queensland University
Address [5] 282429 0
114-190 Canning St, The Range QLD 4700
Country [5] 282429 0
Australia
Other collaborator category [6] 282430 0
University
Name [6] 282430 0
University of Cologne
Address [6] 282430 0
100 Albertus-Magnus-Platz, D-50923 Cologne
Country [6] 282430 0
Germany
Other collaborator category [7] 282431 0
University
Name [7] 282431 0
Brigham Young University
Address [7] 282431 0
268 SFH, Provo UT 84602
Country [7] 282431 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311626 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 311626 0
Ethics committee country [1] 311626 0
Australia
Date submitted for ethics approval [1] 311626 0
30/05/2022
Approval date [1] 311626 0
26/08/2022
Ethics approval number [1] 311626 0
2022-162

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

Contacts
Principal investigator
Name 121770 0
Dr Patrick J Owen
Address 121770 0
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 121770 0
Australia
Phone 121770 0
+61 03 92445013
Fax 121770 0
Email 121770 0
[email protected]
Contact person for public queries
Name 121771 0
Patrick J Owen
Address 121771 0
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 121771 0
Australia
Phone 121771 0
+61 03 92445013
Fax 121771 0
Email 121771 0
[email protected]
Contact person for scientific queries
Name 121772 0
Patrick J Owen
Address 121772 0
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 121772 0
Australia
Phone 121772 0
+61 03 92445013
Fax 121772 0
Email 121772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
In accordance with Australian ethical standards, all de-identified electronic data will be made available in an open access data repository.
When will data be available (start and end dates)?
Indefinitely (no end date) upon completion of the study.
Available to whom?
Anyone.
Available for what types of analyses?
Any, assuming appropriate acknowledgement of the original trial and research team.
How or where can data be obtained?
Data will be made available via a publicly accessible data repository (e.g. Open Science Framework) or by contacting the principal investigator, Dr Patrick J Owen ([email protected]).


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
SourceTitleYear of PublicationDOI
EmbaseAssessing safety and treatment efficacy of running on intervertebral discs (ASTEROID) in adults with chronic low back pain: Protocol for a randomised controlled trial.2023https://dx.doi.org/10.1136/bmjsem-2022-001524
N.B. These documents automatically identified may not have been verified by the study sponsor.