ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000357358

Ethics application status

Approved

Date submitted

5/01/2017

Date registered

8/03/2017

Date last updated

22/10/2021

Date data sharing statement initially provided

9/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Improving long term physical activity before and after joint replacement surgery.

Scientific title

Improving physical activity, pain and function in patients waiting for hip and knee arthroplasty by combining targeted exercise training with behaviour change counselling.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Exercise aNd beHaviour chANge CounsElling (ENHANCE)

Linked study record

Health condition

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

Osteoarthritis

Physical activity

Joint replacement

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention program will consist of group exercise sessions conducted twice per week over a 12-week period (minimum of 24 x 1 hour sessions) using behavioural change principles informed by Health Action Process Approach (HAPA). Each session will run for 60 minutes.

The intervention will comprise of three parts: a) information; b) developing personal action and coping plans; and c) group discussion. The delivery of HAPA will be face-to-face within the exercise session and there will be time for individualised delivery.

The exercise program will be individualised based on the assessment at entry by an accredited exercise physiologist with experience in delivery of exercise to people with chronic health conditions and the intensity and progression of exercises will be determined on an as needs basis.
The required elements of the exercise program will be based on clinical evidence for hip and knee osteoarthritis. Dose will be determined by the supervising Exercise Professional in negotiation with the participant’s preferences.
1. An aerobic component of low to moderate intensity (40-60%HR max, RPE 12-14). In addition to in class exercise that may include walking, cycling or ergometry, a home program aiming to accumulate 20-30 minutes a day on 2-5 days a week will be progressively introduced where safe and practical.
2. Flexibility component initially once daily at home with static stretching to comfortable end of range (up to 15 second holds). Static stretching will also be included in the supervised exercise classes building to 3-5 stretches of up to 30 second duration daily during the program.
3. Isometric strengthening will initially be conducted in supervised exercise classes at 40% Maximal Voluntary Contraction (MVC) with up to 10 holds for up to 6 seconds. Where safe and practical this will be expanded to the home exercise program and repeated daily.
4. Isotonic strengthening will commence at low levels (40% MVC and higher reps – between 10-15) and progress as able to include higher loads and lower repetitions to stimulate strength gains. These will be supervised in class twice a week with one weekly home session with Therabands.

Cognitive components: HAPA focuses on the complex, dynamic relationships between the individual, health behaviours and their environment, where all elements interact and influence each other. This theory postulates that people’s beliefs about their capabilities are a better predictor of their behaviour than are their actual capabilities. For example, people with high self-efficacy regard tasks as a challenge rather than a risk, setting goals for themselves and staying committed to them. People with low self-efficacy avoid difficult tasks; they have low aspirations and a weak commitment to their goals. To increase self-efficacy, strategies to improve goal achievement are embedded throughout the intervention. The intervention is based on the SMART (Specific, Measurable, Achievable, Realistic and Timely) concept, therefore assisting individuals to improve their exercise self-efficacy. People perform better when they are committed to achieving certain goals. Through an understanding of the effect of goal setting on individual performance, health professionals are able to use goal setting to benefit participants. Three moderators indicate goal setting success: i) the importance of the expected outcomes of goal attainment, ii) self-efficacy—one's belief that they are able to achieve the goals, and iii) commitment to others—promises or engagements to others can strongly improve commitment.
The elements described above in relation to such as self-efficacy, planning and self-monitoring will be taught to individuals as part of the group exercise classes. Participants will have the opportunity to create meaningful functional goals for themselves at this time.

We propose to maximise ongoing participation in, and benefits of, the program through the implementation of:
i) individualised exercise intervention with a group setting to improve physical activity through reductions in pain, and improvements in functional capacity
ii) structured psychological frameworks that promote self-efficacy, and
iii) activity self-monitoring via diaries and smart activity monitoring technology for the primary outcome of step count.

Participants will be recruited from the waitlist, it is acknowledged that some participants whilst enrolled in the exercise program may be advised that their surgery has been scheduled and may be unable to complete the trial. This will be accounted for in our analysis.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

Treatment: Other

Comparator / control treatment

Control group will be invited to participate in this study, where they will be asked to complete some questionnaires about their health and activity levels and wear an activity monitor on 3 occasions; when they enter the study, after 24 weeks and again at 6 months after their surgery. We will also check people's blood pressure, walking speed and blood sugar levels using a finger prick test. The group control group will be given some educational materials from Exercise Sport Science Australia about general physical activity guidelines about healthy levels of physical activity.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome measure is daily physical activity (daily step count). Participants will wear an activity monitor (activePAL) for seven consecutive days. Data from the device will be recorded and uploaded to a computer. This data will be averaged over the seven days of activity to calculate a daily step count. Percentage of the day spend in sedentary activities will also be recorded.

Timepoint [1]