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Trial registered on ANZCTR
Registration number
ACTRN12624000624583
Ethics application status
Approved
Date submitted
18/04/2024
Date registered
14/05/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
14/05/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Effects of resistance training on pain, well-being, and inflammation in chronic low back pain
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Scientific title
Effects of resistance training on pain, well-being, and inflammation in chronic low back pain
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Secondary ID [1]
311636
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain
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Condition category
Condition code
Physical Medicine / Rehabilitation
329766
329766
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0
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Physiotherapy
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Musculoskeletal
330330
330330
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will complete a 12-week supervised resistance training program. Across this time, they will attend two group-based (3-4 participants) 60-minute face-to-face resistance training sessions per week (24 total sessions), prescribed and supervised by a qualified physiotherapist from the research group. Before the start of the intervention, a physical assessment (health history; lower back assessment and blood pressure) will be conducted by the physiotherapist. Resistance training sessions will be individualised based on the participant’s muscle strength. After learning the correct technique of each exercise, muscle strength will be determined by a series of submaximal strength tests in week three to determine the required training intensity. Resistance training sessions will consist of a ten-minute general warm up, including dynamic exercises for the trunk, legs, and shoulders. After warm-up, participants will perform 3 sets and 8-12 repetitions of the following resistance exercises with a barbell and weights: squat (1), barbell row (2), deadlift (3), and bench press (4). The selection of exercises is based on a prior study with a similar population and was considered safe. The training intensity will initially be 50% of the maximal strength (adaptation phase) and will gradually increase by 10% every 3 weeks, which is informed by previous studies. Adherence to the resistance training sessions will be assessed by documenting the overall training session attendance, within-session training load completed and rate of perceived exertion (RPE) for each training session.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
Participants will be asked to manage their low back pain as usual (e.g. GP management, over-the-counter pharmacotherapy). No intervention will be provided during the 12-week follow-up. Following completion of the study, participants will be offered a consultation with a qualified physiotherapist from the research group to conduct the same physical assessment (health history; lower back assessment and blood pressure) that the intervention group received to establish an individualised one-off home-based strength training program for the participant. The strength training program will be tailored to the participant's needs and abilities and will include whole-body exercises to improve back pain (e.g., planks, bridging, bird dog).
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain intensity
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Assessment method [1]
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100mm visual analogue scale
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Timepoint [1]
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Baseline, 6- and 12-week after intervention commencement
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Primary outcome [2]
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Well-being (will be assessed as a composite outcome)
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Assessment method [2]
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The Depression Anxiety and Stress Scale will be used to measure the negative emotional states of depression, anxiety and stress.
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Timepoint [2]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [1]
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Disability
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Assessment method [1]
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The Oswestry Disability Index will be used to quantify disability (poor physical function) due to low back pain.
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Timepoint [1]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [2]
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Sleep quality
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Assessment method [2]
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The Pittsburgh Sleep Index will be used to quantify sleep quality and duration over the previous month.
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Timepoint [2]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [3]
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Insomnia severity
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Assessment method [3]
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The Insomnia Severity Index will be used to assess the nature, severity, and impact of insomnia.
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Timepoint [3]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [4]
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Health-related quality of life
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Assessment method [4]
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The EuroQol 5 Dimension 5 Level (EQ-5D-5L) will be used to quantify health-related quality of life.
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Timepoint [4]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [5]
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Habitual physical activity
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Assessment method [5]
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The International Physical Activity Questionnaire (Short Form) will be used to quantify habitual physical activity.
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Timepoint [5]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [6]
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Healthcare professional and treatment expectations (assessed as a composite outcome)
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Assessment method [6]
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A 3-item questionnaire, which has been specifically designed for this study, will be used to assess general recovery expectations and treatment-specific expectations. To measure general expectations of recovery by 6 and 12 weeks, responses are rated from 0 to 10, where zero indicates no improvement and 10 indicates complete recovery. To measure treatment specific expectations to the intervention, responses are rated from 0-10 where zero indicates not at all helpful and 10 indicates extremely helpful.
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Timepoint [6]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [7]
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Activity specific beliefs
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Assessment method [7]
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A 6-item questionnaire will be used to assess the beliefs of safety towards specific physical activities. Questions 1-4 relate to the current and past involvement in a range of physical activities, while questions 5-6 evaluate the belief of safety.
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Timepoint [7]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [8]
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Kinesiophobia
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Assessment method [8]
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Tampa Scale for Kinesiophobia
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Timepoint [8]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [9]
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Pain catastrophising
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Assessment method [9]
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Pain Catastrophising Scale
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Timepoint [9]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [10]
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Pain self-efficacy
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Assessment method [10]
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Pain Self-efficacy Questionnaire
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Timepoint [10]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [11]
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Social Support
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Assessment method [11]
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Multidimensional Scale of Perceived Social Support
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Timepoint [11]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [12]
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Social cohesion
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Assessment method [12]
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Physical Activity Group Environment Questionnaire
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Timepoint [12]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [13]
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Social cohesion
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Assessment method [13]
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Psychological State component of the Sense of belonging instrument
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Timepoint [13]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [14]
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Inflammation
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Assessment method [14]
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Venous blood draws will enable examination of systemic inflammatory markers (e.g., C-reactive protein, interleukin-6)
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Timepoint [14]
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Baseline and 12-week after intervention commencement
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Secondary outcome [15]
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Recruitment
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Assessment method [15]
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The following domains will be documented via audit of recruitment records: [1] enrolled participants compared to total screened potential participants, [2] reasons for ineligibility or declined participation, [3] enrolment timeline, [4] efficacy of recruitment pathways
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Timepoint [15]
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Upon conclusion of the study
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Secondary outcome [16]
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Attrition
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Assessment method [16]
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The following domains will be documented via audit of attrition records: [1] number of participants available for follow-up, [2] reasons for loss to follow-up
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Timepoint [16]
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Upon conclusion of the study
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Secondary outcome [17]
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Adherence
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Assessment method [17]
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The following domains will be documented via audit of adherence records: [1] overall training session attendance, [2] within-session training load completed, [3] rate of perceived exertion (RPE) for each session
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Timepoint [17]
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Upon conclusion of the study
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Secondary outcome [18]
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Data collection
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Assessment method [18]
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The following domains will be documented via audit of data collection records: [1] missing data, [2] reasons for missing data
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Timepoint [18]
434489
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Upon conclusion of the study
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Secondary outcome [19]
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Safety
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Assessment method [19]
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The following domains will be documented via audit of safety records and graded using Common Terminology Criteria for Adverse Events (CTCAE) v5.0: [1] number of adverse events [2] type of adverse events (e.g., pain flare-up, muscle strain), [2] severity of adverse events
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Timepoint [19]
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Every session throughout the 12-week intervention
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Secondary outcome [20]
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Cognitive function (Processing speed)
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Assessment method [20]
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Cognitive function (Processing speed) will be assessed using the Trail Making Test (Trails A) via the NeuRA Trails (NeuRA, Randwick, NSW) application on an iPad.
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Timepoint [20]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [21]
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Cognitive function (Executive function)
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Assessment method [21]
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Cognitive function (Executive function) will be assessed using the Trail Making Test (Trails B) via the NeuRA Trails (NeuRA, Randwick, NSW) application on an iPad.
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Timepoint [21]
434818
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [22]
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Cognitive function (Psychomotor speed and visual tracking)
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Assessment method [22]
434819
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Motor Praxis Task via the Joggle application (Joggle Research, Seattle, WA) on an iPad.
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Timepoint [22]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [23]
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Cognitive function (Attention, working memory)
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Assessment method [23]
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Digital Symbol Substitution Task via the Joggle application (Joggle Research, Seattle, WA) on an iPad.
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Timepoint [23]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [24]
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Cognitive function (Visuospatial orientation)
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Assessment method [24]
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Line Orientation Task via the Joggle application (Joggle Research, Seattle, WA) on an iPad.
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Timepoint [24]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [25]
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Cognitive function (Psychomotor speed, vigilant attention)
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Assessment method [25]
434822
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Psychomotor vigilance task via the Joggle application (Joggle Research, Seattle, WA) on an iPad.
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Timepoint [25]
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Baseline, 6- and 12-week after intervention commencement
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Secondary outcome [26]
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Cognitive function (Working memory)
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Assessment method [26]
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Visual Object Learning Task via the Joggle application (Joggle Research, Seattle, WA) on an iPad.
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Timepoint [26]
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Baseline, 6- and 12-week after intervention commencement
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Eligibility
Key inclusion criteria
(a) adult (aged 18-55 years), (b) has non-specific (no known specific pathology) chronic (12 weeks or longer) low back pain (pain located between the costal margin and above the inferior gluteal folds, with or without leg pain).
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(a) history of spinal surgery, spine trauma (e.g. fracture or car accident), cauda equina symptoms, known structural scoliosis, symptomatic radiculopathy, inflammatory spondyloarthropathies, or non-musculoskeletal causes of low back pain (LBP) (e.g. infection), (b) inability to communicate in English, (c) pregnancy, lactating or <1 year postnatal, (d) any absolute contraindication for exercise training, (e) participation in resistance training or sport that involves resistance training in the last three months (>1 session per month), (f) experienced an injury in the last six weeks.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A team member without contact with participants will obtain and employ the randomisation schedule (creating sequentially numbered, opaque, sealed envelopes).
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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 2 and 6 per block) and stratification for sex to either intervention or control group. The randomisation schedule will be developed using the online software application for randomising participants (https://www.sealedenvelope.com/).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Stata (v17, StataCorp, College Station, Texas, United States of America) will be used for all statistical analyses. Normality of the distribution will be assessed by generating histograms and quantile-quantile plots of residuals. Within-group and between-group changes by time on well-being, inflammation and pain intensity will be examined using linear mixed models with random effects, adjusting for variability within participants. A restricted maximum likelihood fit, providing unbiased estimates and an intention-to-treat approach will be applied. An alpha level of 0.05 will be set for all analyses.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/06/2024
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Actual
24/07/2024
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Date of last participant enrolment
Anticipated
31/12/2024
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
22
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Deakin University
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318105
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Country [1]
318105
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Deakin University Human Research Ethics Committee (DUHREC)
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Ethics committee address [1]
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https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168
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Ethics committee country [1]
314786
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Australia
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Date submitted for ethics approval [1]
314786
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12/02/2024
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Approval date [1]
314786
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04/03/2024
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Ethics approval number [1]
314786
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2024-044
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Summary
Brief summary
A 12-week parallel-group randomised controlled trial examining the effects of a supervised resistance training on pain intensity, well-being, and inflammation compared to usual care in adults with chronic non-specific low back pain will be conducted. It is hypothesised that 12 weeks of resistance training will improve pain intensity, well-being and inflammation compared to usual care in adults with chronic non-specific low back pain.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Luana Main
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Address
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Deakin University, Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, 221 Burwood Hwy, 3125 Burwood, Victoria
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Country
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Australia
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Phone
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+61 392445030
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Luana Main
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Address
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Deakin University, Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, 221 Burwood Hwy, 3125 Burwood, Victoria
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Country
132727
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Australia
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Phone
132727
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+61 392445030
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Fax
132727
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Email
132727
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[email protected]
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Contact person for scientific queries
Name
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Luana Main
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Address
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Deakin University, Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, 221 Burwood Hwy, 3125 Burwood, Victoria
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Country
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Australia
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Phone
132728
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+61 392445030
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Fax
132728
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Email
132728
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial, after deidentification.
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When will data be available (start and end dates)?
Immediately after publication. No end date.
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Available to whom?
Researchers who provide a methodologically sound proposal.
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Available for what types of analyses?
Any purpose
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How or where can data be obtained?
Access subject to approvals by Principal Investigator (
[email protected]
).
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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.
Download to PDF