Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000706673
Ethics application status
Approved
Date submitted
27/06/2014
Date registered
4/07/2014
Date last updated
23/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Sydney Trial Of Prevention: Group based Exercise and Education for Prevention of Low Back Pain: A Feasibility Study
Scientific title
In patients recently recovered from low back pain is an 8 week supervised group exercise and education program, compared to a minimal 30 minute advice session, feasible and acceptable?
Secondary ID [1] 284878 0
nil
Universal Trial Number (UTN)
Trial acronym
STOP Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 292314 0
Condition category
Condition code
Musculoskeletal 292653 292653 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 292692 292692 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group exercise and education program

Participants in the group ‘exercise and education program’ are to receive a single 1 hour assessment session followed by an 8 week group exercise program that is both graded and progressed, supervised by an exercise provider (registered physiotherapist). The sessions will be conducted once per week and will run for one hour. The program will run at a ratio of between 4 - 10 participants per physiotherapist. The program will also include one-on-one time with the physiotherapist to facilitate the commencement of a home exercise program (HEP) which will build upon the exercise conducted within the sessions and enable continuance of exercises once the supervised group exercise program has been completed. The participants will be provided with a single 30 minute HEP session specifically for addressing any barriers to exercise associated with the home exercise program. This HEP session will occur between group sessions three and five.
The exercises / activities implemented as a part of this intervention will focus on four key areas of exercise training identified by the American College of Sports Medicine (cardiorespiratory, resistance, flexibility and neuromotor). All participants will be directed to meet the American College of Sports Medicine’s guidelines for cardiorespiratory exercise with specific resistance, flexibility and neuromotor components implemented according to areas of deficit identified in the initial assessment. The progression of the program will conform to the American College of Sports Medicine’s position statement.

Assessment Session
The purpose of the assessment session is to enable the exercise provider to determine the appropriate level (quantity, intensity and type) of exercises and general activity most suitable for the participant. Time will also be set aside for the implementation of the HEP.

Group Sessions
Exercises conducted in the group sessions will be focused on increasing strength, endurance and coordination of the trunk musculature. Specific exercises in the program may focus on a single area or include aspects from two or more areas above and will emphasise performance of functional everyday activities. Exercise providers will work with participants to provide an individualised and graded exercise program that reflects the participant’s physical capacity and the nature of the work, household, social and sporting activities the participant is involved in. All exercises will be conducted using the participant’s current level of fitness and ability as a starting point, and progress using the position statement on Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise as a guide. Exercise providers will use their clinical judgement to determine what aspects of exercise (cardiorespiratory, resistance, flexibility and neuromotor) to concentrate on in the group sessions. Attendance at group sessions will be recorded.

Educational component
The educational component includes education on basic anatomy and kinesiology, posture and movement, causes and management of low back pain and the benefits of exercise. The delivery of these educational components will be integrated with the provision of exercises such that as the participant is learning to perform the exercise they are also learning the theory behind what they are doing and why it is important to them. This will help in retaining the key principles of both the exercise and the education and assist in self-identification of any possible deconditioning that may occur after the exercise program has been completed.

Home exercise program
Participants will be given two opportunities to discuss their home exercise program one-on-one with their exercise provider: The first will be during the initial assessment; the second will be at the separate HEP session. The aim of the HEP is to have a program in place that will enable participants to continue exercising beyond the duration of the group exercise program. Compliance with the HEP will be measured using a participant exercise diary.
Intervention code [1] 289688 0
Prevention
Intervention code [2] 289728 0
Rehabilitation
Comparator / control treatment
Participants will receive the ‘Guide to Positively Managing Back Pain’ booklet and a single half-hour appointment one-on-one with the exercise provider where they will be taken through the booklet and have it explained to them. Included in this time will be opportunity for the participant to ask any questions they might have about the booklet or its contents. Participants will have the opportunity to contact the exercise provider by phone one time after the end of the session to clarify the information contained in the booklet or ask further questions. In order to maintain the minimalist nature of this intervention exercise providers conducting the intervention are not to volunteer information that goes beyond the scope of the booklet.

The ‘Guide to Positively Managing Back Pain’ booklet has been developed by Bupa and is a publicly available resource. It includes advice on self-management and prevention of back pain as well as a brief overview of types of exercise
Control group
Active

Outcomes
Primary outcome [1] 292495 0
Average number of patients recruited per week.
Timepoint [1] 292495 0
from start of recruitment till enrolment of 40th participant
Primary outcome [2] 292496 0
% of patients maintaining follow-up for the 10 week period.
Timepoint [2] 292496 0
at 10 week follow-up
Secondary outcome [1] 309100 0
% of patients maintaining 80% attendance or higher at group sessions
Timepoint [1] 309100 0
at 10 week follow-up.
Secondary outcome [2] 309101 0
% of patients maintaining 80% compliance with home exercise program.

Compliance with the home exercise program (HEP) will be monitored using a participant exercise diary. Each week the exercise provider will check the diary and note whether the participant has been compliant with the HEP in the preceding week.
Timepoint [2] 309101 0
at 10 week follow-up
Secondary outcome [3] 309102 0
% of patients with valid physical activity measurements.

Physical activity will be objectively assessed with the Actigraph GT3X-Plus accelerometer at baseline and at 10 weeks. It records activity counts and steps taken, which are converted to time spent in sedentary, light, moderate, and vigorous intensity physical activity. The Actigraph is a non-invasive, small, lightweight device that is worn during waking hours for 7 consecutive days on the right hip.
Timepoint [3] 309102 0
at 10 week follow-up

Eligibility
Key inclusion criteria
Recovered from a previous episode of non-specific LBP within the last month. Non-specific low back pain is defined as pain in the area between the 12th rib and buttock crease not attributed to a specific diagnosis such as sciatica, ankylosing spondylitis, vertebral fracture etc. The date of recovery is defined as the 30th consecutive day with pain no greater than 1 on a 0-10 scale.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Previous spinal surgery.
- Any co-existing medical condition which would restrict or prevent safe participation in the exercise program e.g. traumatic brain injury.
- Inadequate English to complete outcome measures.
- Currently participating in an exercise program similar to the one we will evaluate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to treatment group. Consecutively numbered, sealed, opaque envelopes will be used to conceal randomisation.
Allocation will occur immediately following the baseline assessment. At this time, the researcher conducting the baseline assessment will give the envelope containing the allocation to the exercise provider. The researcher will record the participant number, time and place of randomisation and then leave. The exercise provider will open the envelope and record both the randomisation number and treatment group. The exercise provider will organise for the provision of the prescribed intervention, either minimal intervention or group exercise. Participants will be considered to have entered the study at the time that the envelope is given to the exercise provider.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by an independent investigator by means of a computer program using the simple randomisation method. There will be a single sequence generated and enough to allow for the recruitment of up to 40 participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a pilot study there is no sample size required to achieve a given power. It was decided that 40 participants would provide a reasonable assessment of feasibility.
- Rate of uptake will be expressed as number of patients recruited per week
- Compliance with the exercise program will be measured by % of patients maintaining 80% compliance or higher.
- Compliance with wearing the Actigraph will be measured by % participants with valid data at each time point.
- Dropout rate will be measured by % of patients maintaining follow-up for the 10 week period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2014
Actual
17/09/2014
Date of last participant enrolment
Anticipated
31/10/2014
Actual
16/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8366 0
2112 - Ryde
Recruitment postcode(s) [2] 8367 0
2031 - Randwick
Recruitment postcode(s) [3] 8368 0
2220 - Hurstville
Recruitment postcode(s) [4] 8369 0
2088 - Mosman
Recruitment postcode(s) [5] 8370 0
2148 - Blacktown
Recruitment postcode(s) [6] 8371 0
2031 - Clovelly
Recruitment postcode(s) [7] 8372 0
2150 - Parramatta
Recruitment postcode(s) [8] 8373 0
2010 - Darlinghurst
Recruitment postcode(s) [9] 8374 0
2032 - Kingsford

Funding & Sponsors
Funding source category [1] 289497 0
University
Name [1] 289497 0
University of Sydney bridging support grant
Country [1] 289497 0
Australia
Primary sponsor type
University
Name
The George Institute for Global Health, Sydney Medical School, The University of Sydney
Address
PO Box M201, Missenden Road, Sydney NSW 2050 Australia
Country
Australia
Secondary sponsor category [1] 288180 0
None
Name [1] 288180 0
Address [1] 288180 0
Country [1] 288180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291250 0
University of Sydney Human Research Ethics Commitee
Ethics committee address [1] 291250 0
Level 6, Jane Foss Russell, The University of Sydney, NSW 2006
Ethics committee country [1] 291250 0
Australia
Date submitted for ethics approval [1] 291250 0
Approval date [1] 291250 0
02/05/2014
Ethics approval number [1] 291250 0
2014/238

Summary
Brief summary
This study will take 40 participants who have recently recovered from low back pain and randomly allocate them to either an 8 week comprehensive, supervised group exercise and education program or a minimal intervention consisting of one 30 minute education and advice session. Outcomes will be assessed at 10 weeks. The aims of the STOP Pilot are to: 1) Test feasibility of recruitment and enrolment procedures; 2) Test acceptability and adherence to the intervention; and 3) Test our processes and procedures for collecting outcome data.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 49510 0
Prof Chris Maher
Address 49510 0
The George Institute for Global Health
PO Box M201, Missenden Road, Sydney NSW 2050 Australia
Country 49510 0
Australia
Phone 49510 0
+61 2 96570382
Fax 49510 0
+61 2 96570301
Email 49510 0
[email protected]
Contact person for public queries
Name 49511 0
Mr Matthew Stevens
Address 49511 0
The George Institute for Global Health
PO Box M201, Missenden Road, Sydney NSW 2050 Australia
Country 49511 0
Australia
Phone 49511 0
+61 2 96570346
Fax 49511 0
+61 2 96570301
Email 49511 0
[email protected]
Contact person for scientific queries
Name 49512 0
Prof Chris Maher
Address 49512 0
The George Institute for Global Health
PO Box M201, Missenden Road, Sydney NSW 2050 Australia
Country 49512 0
Australia
Phone 49512 0
+61 2 96570382
Fax 49512 0
+61 2 96570301
Email 49512 0
[email protected]

No information has been provided regarding IPD availability


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.