Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000270617
Ethics application status
Approved
Date submitted
5/03/2014
Date registered
14/03/2014
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Date results information initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-paced walking for chronic low back pain
Scientific title
Effectiveness of affect-regulated walking on disability and physical activity levels of adults with chronic low back pain
Secondary ID [1] 284196 0
Nil
Universal Trial Number (UTN)
U1111-1154-0745
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 291301 0
Condition category
Condition code
Musculoskeletal 291653 291653 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291654 291654 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Affect-regulated walking intervention: 8-week home-based walking intervention using affect-regulation to an intensity to feel 'fairly good' (using the Feeling Scale). The intervention dosage is aiming to achieve Australian physical activity guidelines of 30-60 minutes of walking on 5 or more days each week. Accelerometers will collect objectively measured physical activity levels during week 3, 6 and 8 of the intervention to monitor adherence, and the participants will complete a pen and paper walking diary as an additional adherence measure.
Intervention code [1] 288892 0
Treatment: Other
Intervention code [2] 288893 0
Rehabilitation
Intervention code [3] 288894 0
Behaviour
Comparator / control treatment
Usual advise walking: 8-week home-based walking intervention. The intervention dosage is aiming to achieve Australian physical activity guidelines of 30-60 minutes of walking on 5 or more days each week. No specific advice or education will be provided regarding exercise intensity regulation. Accelerometers will collect objectively measured physical activity levels during week 3, 6 and 8 of the intervention to monitor adherence, and the participants will complete a pen and paper walking diary as an additional adherence measure.
Control group
Active

Outcomes
Primary outcome [1] 291582 0
Disability as assessed via the Oswestry Disability Questionnaire (mean score)
Timepoint [1] 291582 0
baseline, completion of intervention (week 8) and 3 months post intervention
Secondary outcome [1] 307115 0
Physical activity as measured using 7 day accelerometry (GENEActive) (mean total counts/day)
Timepoint [1] 307115 0
baseline, end of intervention (week 8) and 3 month post intervention as effectiveness outcome measure

additional time points week 3 and week 6 of intervention to monitor adherence
Secondary outcome [2] 307116 0
exercise capacity as measured using the 6 minute walk test (mean distance walked in m)
Timepoint [2] 307116 0
baseline, end of intervention and 3 months post intervention
Secondary outcome [3] 307117 0
Exercise self-efficacy as measured by the Barriers Self-Efficacy Scale
Timepoint [3] 307117 0
baseline, end of intervention and 3 months post intervnetion
Secondary outcome [4] 307118 0
Health-related quality of life by the RAND-36 questionnaire
Timepoint [4] 307118 0
baseline, end of intervention, 3 months post intervention
Secondary outcome [5] 307119 0
Pain using a 0-10 numerical rating scale
Timepoint [5] 307119 0
baseline, end of intervention and 3 months post intervention and
Secondary outcome [6] 307120 0
adherence using a self-report daily walking diary (mean minutes walked/day)
Timepoint [6] 307120 0
duration of 8 week intervention
Secondary outcome [7] 307121 0
Participant satisfaction using questionnaire developed for the study
Timepoint [7] 307121 0
end of intervention

Eligibility
Key inclusion criteria
age 18-64 years to align with the Australian Physical Activity Guidelines bracket,with chronic low back pain (current symptoms persisting longer than 3 months) not achieving Australian physical activity guidelines (30-60 minutes of moderate intensity physical activity on 5 or more days each week)
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
meeting or exceeding current Australian physical activity guidelines; pregnancy (or intended pregnancy for duration of intervention); any other condition deemed as a contraindication to increasing physical activity levels e.g. unstable cardiac conditions (including cardiac medications) or musculoskeletal conditions; predominantly bed-ridden; - previous spinal surgery; medico-legal involvement; unable to speak and understand English fluently; unable to attend all testing sessions

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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2014
Actual
8/04/2014
Date of last participant enrolment
Anticipated
Actual
27/11/2017
Date of last data collection
Anticipated
10/04/2018
Actual
17/05/2018
Sample size
Target
62
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 288829 0
University
Name [1] 288829 0
University of South Australia
Country [1] 288829 0
Australia
Primary sponsor type
Individual
Name
Dr Katia Ferrar
Address
University of South Australia, North Terrace, Adelaide,
South Australia, 5000
Country
Australia
Secondary sponsor category [1] 287523 0
None
Name [1] 287523 0
Address [1] 287523 0
Country [1] 287523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290669 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 290669 0
GPO Box 2471, Adelaide, South Australia, 5001
Ethics committee country [1] 290669 0
Australia
Date submitted for ethics approval [1] 290669 0
23/01/2014
Approval date [1] 290669 0
24/02/2014
Ethics approval number [1] 290669 0
0000032487

Summary
Brief summary
The individual and community cost of chronic low back pain (CLBP) is staggering. Guidelines recommend physical activity (PA) as a management for CLBP. Adults with CLBP report unique barriers to PA which need to be overcome to facilitate long term PA behaviour change. Walking, regulated by an internal sense of emotion (affect-regulated), may provide an effective approach to increase PA in people with CLBP. The primary hypothesis is that affect-regulated walking (ARW) will lead to improved disability status and increased PA levels compared with usual advice walking (UAW).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46678 0
Dr Katia Ferrar
Address 46678 0
University of South Australia
City East Campus, Cnr North Terrace and Frome Road,
Adelaide, South Australia, 5000
Country 46678 0
Australia
Phone 46678 0
+ 61883022554
Fax 46678 0
Email 46678 0
[email protected]
Contact person for public queries
Name 46679 0
Dr Katia Ferrar
Address 46679 0
University of South Australia
City East Campus, Cnr North Terrace and Frome Road,
Adelaide, South Australia, 5000
Country 46679 0
Australia
Phone 46679 0
+61883022554
Fax 46679 0
Email 46679 0
[email protected]
Contact person for scientific queries
Name 46680 0
Dr Katia Ferrar
Address 46680 0
University of South Australia
City East Campus, Cnr North Terrace and Frome Road,
Adelaide, South Australia, 5000
Country 46680 0
Australia
Phone 46680 0
+61883022554
Fax 46680 0
Email 46680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Research team yet to discuss/decide.


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.