ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000227594

Ethics application status

Approved

Date submitted

6/01/2015

Date registered

12/03/2015

Date last updated

10/05/2023

Date data sharing statement initially provided

30/10/2018

Date results provided

3/05/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Stepped Care Approach for Medial Tibiofemoral Osteoarthritis (STrEAMline)

Scientific title

STrEAMline: The remission of symptoms in Tibiofemoral Osteoarthritis following an adaptive treatment strategy in overweight/obese participants

Secondary ID [1]

NIL

Universal Trial Number (UTN)

U1111-1165-7198

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Medial tibiofemoral Osteoarthritis

Obesity

Depression

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Mental Health

Depression

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1 – 18 week diet and exercise as prescribed by the Healthy Weight for Life program (healthyweightforlife.com.au)
The Healthy Weight for Life is a specialised arthritis chronic disease management program that targets multiple modifiable OA risk factors by carefully integrating:
a. Weight loss and improved nutrition - a stepped intervention designed to achieve a progressive and practical implementation of normal, healthy portion-controlled eating and drinking, through education and resources. The participants will receive a resource pack that contains the Portion Planning eating system and tools (Healthy Weight for Life week-by-week guide book, KickStart (trademark) meal replacement, portion planner disc, reusable drink bottle, insulated combined lunch and snack bag and a tape measure for taking waist measurements) and the relevant instructions on how to use it. Throughout the program, the participants will be given a choice of meal replacement flavours and provided access to recipes for low fat and low glycaemic index meals. During the first 6 weeks (Motivational Loss Phase) 2 meals each day are replaced with a VLCD meal replacement KicStart (trademark). As patients move through the remaining 2 phases of the Integrated Osteoarthritis Management program, the number of meals replaced with KicStart (trademark) is gradually reduced to zero as they progressively build up the new sustainable healthy eating and lifestyle habits that are needed to keep weight under control in the longer term. Adequate hydration will also be encouraged using “free drinks” (e.g. mineral water, vegetable juice). Online healthy eating and lifestyle education will be provided, as will coaching and personalised telephone motivation, support and advice.
b. Muscle strengthening - an exercise program focused on balance, strengthening and improving range of motion of quadriceps, calf, hamstrings, gluteal and hip flexor and abductor muscles. This is a home-based intervention for which the participants will receive resources developed in collaboration with physiotherapists. The resources and tools included are a manual with step-by-step instructions for 42 different exercises across 3 levels, a DVD demonstrating and explaining each of the 42 exercises, resistance exercise tube and a hot and cold pack for pain management. Participants will be encouraged to maintain a routine of 3 sets of 10 minutes of physical daily activity (such as walking or water based), and between 12 to 15 level 1 strength, balance and mobility exercises that should be performed at least 3 times per week, on phase 1 (weeks 1-6) of the program, ideally separating each session by a day or two. Once comfortably completing the level 1 exercises, there to move Phase 2 (weeks 7-12), which will require a 1 x 30 minutes (or more) of daily physical activity (either land or water based), and between 12 to 15 level 2 strength, balance and mobility exercises that should be performed at least 3 times per week, ideally separating each session by a day or two. Finally, phase 3 (weeks 13 - ongoing) will require 30 minutes (or more) of physical activity daily (either land or water based) or the use of a pedometer to target 10,000 steps per day and between 12 to 15 level 3 strength, balance and mobility exercises that should be performed at least 3 times per week, ideally separating each session by a day or two. The time taken to perform the strength, balance and mobility exercises is not prescribed. Participants are asked to only exercise within their physical capabilities and to not continue exercising with increasing pain or pain that is moderate to severe. No specific target intensity is prescribed as the range of capabilities varies widely. If there are particular exercises in a level that they cannot do for any reason, they are to continue with the exercises that can be comfortably managed.
c. Monitoring and Engagement - A central team of clinical, navigation and logistical staff provide personalised engagement to each individual. PrimaLinx (Trademark) software enables extensive "real time" monitoring and analysis of each individual's symptom, biometric, satisfaction and engagement data. A live dashboard then directs proactive engagement by the central team through a multi-channel 2-way person communication (phone, SMS, email, electronic message board and reply paid post). All participants complete a weekly online weight and waist circumference tracking record that is monitored for progress towards set targets and engagement. Participants also have the option to complete a Diet and Activity Journal to identify where portions or habits can be improved.

- Reassessment at 20 weeks – If participants have achieved a PASS score that is equivalent to disease remission they will continue on the diet and exercise protocol until the 32 week mark.
- Participants that have not achieved remission will enter the Adaptive Treatment Stage

Arm 2 – Adaptive Treatment Stage
- At this stage, participants will be evaluated for referral into one of the three treatment arms depending on which of the following impediments present as the most significant:

- Depression: For patients that score less than or equal to 14 on the DASS-21, defined as moderately depressed.
Referred to CRUFAD – an online Cognitive Behavioural Therapy (CBT) course for the treatment of depression. This course involves 6 online lessons to be completed over 12-week period. The approximate duration is 30 minutes per session. This course provides a structured learning plan, downloadable materials, and guidance from a dedicated Clinical Psychologist at St Vincent’s Hospital who is experienced in the treatment of depression and anxiety. Research shows that online CBT programs can be just as effective as face-to-face CBT, whilst being quicker to access and more convenient than face-to-face treatments.
COURSE CONTENT:
- Lesson 1 - The diagnosis: Learning about the symptoms of depression
- Lesson 2 - Monitoring Your Thoughts and Activities: Identify the things a person does and the things a person thinks that maintain their symptoms of depression (that keeps their symptoms going)
- Lesson 3 - Learn to Improve Your Activities and Thoughts: Learn to challenge unhelpful thoughts and self-criticism.
- Lesson 4 - Facing Your Fears: Learn about how to confront your fears with step-by-step exercises.
- Lesson 5 - Being Assertive: Learn how to be assertive with effective communication techniques.
- Lesson 6 - Preventing Relapse: Learn about relapse prevention and how to stay well over the long-term.
CRUFAD research shows that three quarters of people who complete the depression course recover from symptoms of depression, and stay well over the longer term.
By the end of the program, the participant will be able to:
a. Identify their own symptoms of depression,
b. Identify the things that they do, and the thinking habits that maintain their symptoms of depression
c. Understand how depression is treated.
d. Learn and practice skills and techniques that will help them get better control over their symptoms.
e. Feel more confident in their ability to stay well over the long-term, and control heir symptoms of depression.

- Varus Thrust: Measured by clinical examiners through visual gait analysis, and if confirmed Varus Thrust, then by three-dimensional knee kinematics assessment (KneeKG System).
Participants with a varus thrust and varus malalignment of greater than or equal to 6 degrees will receive treatment to correct it via an unloader knee brace (provided free of charge to the participants).
- The Unloader FIT knee brace, developed and commercialised by Ossur, will be provided to the participants by the Australian Orthotic Technologies free of charge.
- The knee brace will be measured and fitted by a certified trained practitioner at the time of the participant's visit and inclusion to this treatment group.
- Participants will be advised to wear the brace throughout the day for normal activities of daily living. The brace will be worn for the whole duration of the Adaptive Treatment Stage (week 20 to 32).
- When first using the brace, the advice will be to gradually buildup the usage time, starting with up to 3 hours a day in active use and increase by a maximum of 1-2 hours each day.
- Participants with peripheral vascular disease, neuropathy, and sensitive skin will be monitored for any adverse reaction and will receive the appropriate required medical supervision.
- The Unloader FIT is field adaptable to relieve knee pain. Modifications to flexion/extension stops, DFS straps (Upper Dynamic Force Straps) and shell contour will only be made by certified practitioners.

- Quadriceps Weakness: Compared to normative data (maximum voluntary contraction test – dynamometer).
- Participants will follow a strengthening program designed and published by Bennell et al, 2008.
- The aim of the program is to improve the strength of the quadriceps. The participants in the quadriceps strengthening group will complete five specific non-weight-bearing exercises with the affected (most symptomatic or right) leg:
1. Quads over a roll (inner range knee extension)-using resistance of ankle weights.
2. Knee extension in sitting - start sitting with knee at 90 degrees flexion, fully extend using resistance of ankle weights.
3. Knee extension with hold at 30 degrees knee flexion - start sitting with knee at 90 degrees flexion, extend to 30 degrees using resistance of ankle weights.
4. Straight leg raise - start supine, raise leg to 30 degrees hip flexion using resistance of ankle weights.
5. Elastic band exercise - start sitting with knee at 90 degrees flexion, extend to 60 degrees against resistance of elastic band.
Ten repetitions will be performed in each set of quadriceps exercises. Two sets will be performed at the start of the program, progressing to three sets as quickly as possible. The starting weight should be the participant's 10-repetition maximum weight if possible. However, the starting weight can also be determined by asking the participant their level of effort, which should be 5-8 out of ten (hard to very hard) on the modified Borg RPE CR-10 scale for strength training. Each repetition will be performed slowly and in a controlled manner. The end position is held for five seconds initially and progressed to ten seconds. Breath holding during the isometric component of the exercises can increase blood pressure; therefore participants will be instructed to continue breathing throughout each phase (concentric, isometric and eccentric) of the exercises. Exercises should be carried out within tolerable levels of pain. The same pain monitoring scale as described above will be used and pain should subside to usual levels by the next day with no increase in swelling following the exercise session. If joint swelling or 'unacceptable' pain occurs, the resistance, frequency and/or number of repetitions will be reduced. Progression is again an important part of the program and participants will aim to increase their ankle weight or elastic band resistance at regular intervals during the program as guided by their physiotherapist. During all exercises, the level of effort experienced should be self-rated as at least five out of ten (hard) on a RPE CR-10 scale for strength training.
- Participants will be asked to perform the prescribed exercises at home four times per week, and are expected to take approximately 30-45 minutes to complete them.
- They will also be asked to have booster session visits, which will consist of 7 face to face sessions, over the 12-week period for the Adaptive Treatment Stage. These sessions will be performed on a group basis, under the supervision of a physiotherapist, and are expected to take approximately 30-45 minutes.
- There will be no formal control of adherence to the home exercise program, but the participants will be checked for form and execution, by the physiotherapist, during their booster visit sessions

- Participants with multiple problems at 20-weeks
- For those participants who fit the criteria for entry into more than one treatment arm at the 20-week assessment the following decision-making matrix will be implemented in order to categories each participant:
Depression > Varus thrust > Quadriceps weakness
- In accordance with this matrix, any participant who qualifies for multiple treatment arms – of which depression is one of them – will be treated for their depression over any problems with alignment and muscle weakness. Similarly, if a participant has both a varus thrust and quadriceps weakness they will enter the treatment arm for varus thrust.
The decision to rank these treatment modalities in this way is due to the level of impact each of these problems has to achieving remission of OA. A recent study by Shimura et al, 2014 found that pain severity in patients with depression was significantly increased in comparison to that in those without depression, suggesting that depression complicated with knee OA is associated with the symptoms rather than the severity of the disease. Furthermore, depression has a high impact on not only OA but also quality of life. For this reason, it is extremely important that all participants with depression receive adequate treatment.
Ranking varus thrust ahead of quadriceps weakness was decided with the hope that correcting existing malalignment will help to improve the mechanical functioning of the joint, and in doing so will allow the muscles that act on the knee joint to function correctly.

Final assessment at 32 weeks
- Participants in both the active treatment and control group will be reassessed at 32 weeks for their weight and BMI measurements and will have their final PASS score calculated.

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Devices

Intervention code [3]

Behaviour

Comparator / control treatment

The Control Group will be provided with a selection of education pamphlets. These fact sheets will be taken from MyJointPain.org.au, a website which was launched in partnership with Arthritis Australia and is a source of reliable information for individuals with OA. It can inform patients if they have the disease and how to manage it. Similarly, it provides users with a collection of OA healthcare services in order to allow patients to determine who is best suited to manage their disease.

Control group

Active

Outcomes

Primary outcome [1]

Disease Remission to be measured by the Patient Acceptable Symptom State Score (PASS)

Timepoint [1]

At Baseline and at 20 and 32 weeks after intervention commencement

Secondary outcome [1]

Knee pain as assessed using a Visual Analogue Scale

Timepoint [1]