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Trial registered on ANZCTR


Registration number
ACTRN12615000015549
Ethics application status
Approved
Date submitted
10/12/2014
Date registered
14/01/2015
Date last updated
6/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Prescribing the maximum tolerated dose of walking for people with severe knee osteoarthritis: A Phase II, Randomised Controlled Trial
Scientific title
What are the effects of a prescribed walking program of 70 minutes per week for 12 weeks versus standard care only for pain, cardiovascular risk, function and quality of life for people with severe knee osteoarthritis and at least moderate risk of cardiovascular disease - a randomised controlled trial.
Secondary ID [1] 285821 0
Nil
Universal Trial Number (UTN)
U1111-1165-0716
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 293731 0
Cardiovascular disease 293732 0
Condition category
Condition code
Musculoskeletal 294030 294030 0 0
Osteoarthritis
Cardiovascular 294082 294082 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to standard care, participants in the intervention group will be prescribed a walking dose of 70 minutes per week, of at least moderate intensity using the rate of perceived exertion scale with a a score of at least 3/10, in bouts of at least 10 minutes. The weekly dose will be completed for 12 weeks in the community. The walking doses will be completed in the community using normal assistive devices, such as a walking stick if required. Participants will continue taking their usual medications and other normal strategies to manage their knee osteoarthritis.

To increase the likelihood of adherence to the intervention and maximise the effectiveness of the intervention, we will use the following behavioural change techniques and strategies: Single planning session of up to 30 minutes with goal setting - a physiotherapist will assist the participant to determine when and where to complete the dose of walking; Supervision - physiotherapist supervision of one session of walking weekly; Monitoring - each participant will wear a pedometer to self monitor the number of steps each week. They will also complete a logbook to record number of steps and time spent walking each week. A physiotherapist will monitor their progress with a weekly phone call or send weekly SMS reminders; Engaging social supports - each participant will be encouraged to walk with a friend, or family member or other research participant.
Intervention code [1] 290797 0
Rehabilitation
Comparator / control treatment
Standard care is non-operative management to manage pain and symptoms and may include pharmacological or non-pharmacological interventions providing these do not include prescription of physical activity.
Control group
Active

Outcomes
Primary outcome [1] 293807 0
The primary outcome is average knee pain over the previous week measured by a 0-10 Numerical Pain Rating Scale.
Timepoint [1] 293807 0
Baseline and post intervention (Week 12)
Secondary outcome [1] 311909 0
Physical activity level measured by activity monitor worn continuously for 7-days

Timepoint [1] 311909 0
Baseline and post intervention (week 12)
Secondary outcome [2] 311910 0
Resting blood pressure - systolic and diastolic (mm Hg) using a blood pressure monitor
Timepoint [2] 311910 0
Baseline and post intervention (week 12)
Secondary outcome [3] 311911 0
Body mass index (kg/m2) using scales for weight and tape measure for height
Timepoint [3] 311911 0
Baseline and post intervention (week 12)
Secondary outcome [4] 311912 0
Waist circumference (cm) using a tape measure
Timepoint [4] 311912 0
Baseline and post intervention (week 12)
Secondary outcome [5] 312041 0
Total cholesterol (mmol/L), low-density lipoprotein (mmol/L), high-density lipoprotein (mmol/L), triglycerides (mmol/L), and fasting glucose level (mmol/L) using single blood test via local pathology department.
Timepoint [5] 312041 0
Baseline and post intervention (week 12)
Secondary outcome [6] 312042 0
Pain, stiffness and activity limitation using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [6] 312042 0
Baseline and post intervention (week 12)
Secondary outcome [7] 312043 0
40 metre (4 x 10 metres) fast paced walk test as per OARSI functional performance measure guidelines
Timepoint [7] 312043 0
Baseline and post intervention (week 12)
Secondary outcome [8] 312044 0
30-second chair stand test as per OARSI fucntional performance measure guidelines
Timepoint [8] 312044 0
Baseline and post intervention (week 12)
Secondary outcome [9] 312045 0
Health-related quality of life using the EuroQol (EQ-5D and EQ-VAS) questionnaire
Timepoint [9] 312045 0
Baseline and post intervention (week 12)

Eligibility
Key inclusion criteria
(1) Adult aged at least 50 years and living independently in the community.
(2) Diagnosed with severe knee osteoarthritis rated as grade III or IV determined radiogaphically.
(3) Have a cardiovascular risk profile with at least 2 total risk factors using stage 2 of the Adult Exercise Screening Tool.
(4) Able to participate safely in the moderate-intensity physical activity trial using stage 1 of the Adult Exercise Screening Tool.
(5) Able to understand English.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Live in supported accommodation such as a nursing home.
(2) Report daily resting level of pain to be 9 or 10 on a 0 (no pain) to 10 (worst possible pain) Numerical Pain Rating Scale.
(3) Have very high levels of psychological distress as measured by the Kessler 10 questionnaire with a K10 score > 29.
(4) Have an intellectual impairment as measured by the Short Portable Mental Status Questionnaire with a score of 7 or less.
(5) Have a systemic arthritic condition such as rheumatoid arthritis.
(6) Have a neurological condition that affects walking.
(7) Had knee surgery or intra-articular corticosteroid injection within past six months.
(8) Using oral corticosteroids within four weeks.

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)
Participants will be randomly assigned using sealed opaque envelopes prepared by an independent researcher with no role in recruitment or assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design with a computer random number generator
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)
Efficacy
Statistical methods / analysis
We aim to recruit 44 participants (22 in each group allowing for 10% loss to follow up) providing 80% power of detecting a difference of 2.8 units for the primary outcome of pain, assuming SD of 3.0 units, at a 5% significance level using a two tailed test.

Intention to treat analysis will be performed including all available data regardless of adherence to protocol.

Data analysis will use ANCOVA to compare the two groups using post intervention (week 12) data for all the primary and secondary outcome measures. Baseline measures will be used as the covariate.

Adherence will be reported using the percentage of scheduled sessions completed and percentage of the prescribed walking dosage completed each week. Any adverse events will be reported in the manuscript.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3244 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 3245 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 9030 0
3128 - Box Hill
Recruitment postcode(s) [2] 9031 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 290381 0
University
Name [1] 290381 0
La Trobe University
Rehabilitation Research Focus Area
Sport, Exercise and Rehabilitation
Address [1] 290381 0
La Trobe University
Bundoora VIC 3086
Country [1] 290381 0
Australia
Primary sponsor type
Individual
Name
Jason Wallis
Address
Box Hill Hospital
Building B - Level 3
8 Nelson Rd
Box Hill VIC 3128
Country
Australia
Secondary sponsor category [1] 289108 0
Individual
Name [1] 289108 0
Nicholas Taylor
Address [1] 289108 0
La Trobe University and Eastern Health
Level 2, 5 Arnold Street
Box Hill VIC 3128
Country [1] 289108 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292085 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 292085 0
Level 2, 5 Arnold Street
Box Hill VIC 3128
Ethics committee country [1] 292085 0
Australia
Date submitted for ethics approval [1] 292085 0
26/11/2014
Approval date [1] 292085 0
10/03/2015
Ethics approval number [1] 292085 0
E11-2014

Summary
Brief summary
Low physical activity levels and poor cardiovascular health are big problems for people with severe knee osteoarthritis. This study is the first in the world to find out if a walking program can make a difference to their knee pain and cardiovascular health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53410 0
Mr Jason Wallis
Address 53410 0
Box Hill Hospital
Building B, Level 3
8 Arnold Street
Box Hill VIC 3128
Country 53410 0
Australia
Phone 53410 0
+61 3 9895 3715
Fax 53410 0
Email 53410 0
jason.wallis@easternhealth.org.au
Contact person for public queries
Name 53411 0
Mr Jason Wallis
Address 53411 0
Box Hill Hospital
Building B, Level 3
8 Arnold Street
Box Hill VIC 3128
Country 53411 0
Australia
Phone 53411 0
+61 3 9895 3715
Fax 53411 0
Email 53411 0
jason.wallis@easternhealth.org.au
Contact person for scientific queries
Name 53412 0
Mr Jason Wallis
Address 53412 0
Box Hill Hospital
Building B, Level 3
8 Arnold Street
Box Hill VIC 3128
Country 53412 0
Australia
Phone 53412 0
+61 3 9895 3715
Fax 53412 0
Email 53412 0
jason.wallis@easternhealth.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary