Trial Review

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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
Date results information 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] 290842 0
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 301518 0
Physical activity 302130 0
Joint replacement 302131 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301236 301236 0 0
Physiotherapy
Musculoskeletal 301237 301237 0 0
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] 296772 0
Lifestyle
Intervention code [2] 296773 0
Behaviour
Intervention code [3] 296774 0
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] 300652 0
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] 300652 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [1] 330511 0
Pain (visual analogue scale)
Timepoint [1] 330511 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [2] 330522 0
The SF-36 has been changed to the 'Quality of life' SF-12.
Timepoint [2] 330522 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [3] 330523 0
The items used to measure the HAPA model have been adapted from those used in previous studies of physical activity. However are designed specifically for this study. The items will assess task self-efficacy, five items, eg, “I am confident I can do regular exercise over the next week, even when....."
Timepoint [3] 330523 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [4] 330524 0
Function (Oxford Hip and Knee Score)
Timepoint [4] 330524 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [5] 331835 0
The items used to measure the HAPA model have been adapted from those used in previous studies of physical activity. However are designed specifically for this study. The items will assess habit behaviour, four items, eg, “Do you agree that doing regular exercise is something..."
Timepoint [5] 331835 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [6] 331836 0
The items used to measure the HAPA model have been adapted from those used in previous studies of physical activity. However are designed specifically for this study. The items will assess attitude, three items, eg, “Doing regular exercise over the next week would be..."
Timepoint [6] 331836 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [7] 331837 0
The items used to measure the HAPA model have been adapted from those used in previous studies of physical activity. However are designed specifically for this study. The items will assess intention, three items, eg, “In regards to doing regular exercise over the next week, do you agree that..."
Timepoint [7] 331837 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [8] 331838 0
Mobility assessed using Timed Up and Go
Timepoint [8] 331838 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [9] 332522 0
The items used to measure the HAPA model have been adapted from those used in previous studies of physical activity. However are designed specifically for this study. The items will assess social influences, four items, eg, “In regards to doing regular exercise over the next week, do you agree that..."
Timepoint [9] 332522 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [10] 332523 0
The items used to measure the HAPA model have been adapted from those used in previous studies of physical activity. However are designed specifically for this study. The items will assess perceived behavioural control, four items, eg, “In regards to doing regular exercise over the next week, do you agree that... ..."
Timepoint [10] 332523 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).
Secondary outcome [11] 332524 0
The items used to measure the HAPA model have been adapted from those used in previous studies of physical activity. However are designed specifically for this study. The items will assess action planning, four items, eg, “I have made a plan regarding … ."
Timepoint [11] 332524 0
This measure will be taken upon entry to the study (TEST 1), and at approximately six months (TEST 2), and then six months after surgery (TEST 3).

Eligibility
Key inclusion criteria
All new and existing (<6 months on list) patients on the LGH surgery wait list, 18 - 80 years and under.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable medical conditions whereby participation in exercise may present an additional health risk as determined by the consulting surgeon. Participants with Parkinson's disease or similar progressive neurological conditions and participants confined to a wheelchair will be excluded. As well, potential participants unable to attend testing sessions, commit to 12 continuous weeks of exercise classes, or unable to provide independent informed consent to participate will be excluded.

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)
The method to be used to implement random allocation will be an envelope system where an independent source will prepare and order the envelopes to ensure that the sequence is concealed until groups are assigned to participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be carried out by an independent source using a computerised statistical package.
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
Between group differences will be analysed using a two-way repeated measures ANOVA to determine differences between groups (exercise vs usual care) and between time points (TEST 1, TEST 2 and TEST 3).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2017
Actual
11/08/2017
Date of last participant enrolment
Anticipated
Actual
26/04/2019
Date of last data collection
Anticipated
30/03/2020
Actual
19/01/2021
Sample size
Target
110
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 7219 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 14984 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 295275 0
Charities/Societies/Foundations
Name [1] 295275 0
Clifford Craig Medical Trust
Country [1] 295275 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Locked Bag1322
Launceston
TAS
7250
Country
Australia
Secondary sponsor category [1] 294099 0
None
Name [1] 294099 0
Address [1] 294099 0
Country [1] 294099 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296610 0
Tasmania Health & Medical Human Research Ethics Committee (EC00337
Ethics committee address [1] 296610 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart
TAS
7001
Ethics committee country [1] 296610 0
Australia
Date submitted for ethics approval [1] 296610 0
14/11/2016
Approval date [1] 296610 0
20/03/2017
Ethics approval number [1] 296610 0
H0016201

Summary
Brief summary
Waiting for publicly funded hip or knee joint replacements (arthroplasty) can take over 12 months, and low physical activity levels while waiting for surgery may contribute to development of secondary diseases and reduce health benefits post-surgery.

The aim of the project is to quantify the benefits of combining a group exercise training program with targeted behaviour change counselling on ongoing physical activity participation and health related outcomes in patients on the hip or knee arthroplasty wait list. The objectives are to compare the effectiveness of this unique intervention compared to a usual care control group on daily physical activity (daily step count and percentage of day spent in sedentary activities), pain ratings and function as well as changes in clinical markers linked with potential common chronic diseases (diabetes and cardiovascular disease).

This study seeks to determine if a novel intervention that combines effective behaviour change based on Social Cognitive Theory (SCT) with an exercise training program can elicit long term increases in physical activity in patients requiring hip or knee arthroplasty, and reduce comorbidity development while waiting for surgery. Such a model is likely to be of benefit through decreased disability, reductions in multi-morbidities, reduced pain and medication use, and earlier return to activities of daily living post-surgery. These benefits capitalise on the investment cost associated with surgery.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 70286 0
A/Prof Andrew Williams
Address 70286 0
University of Tasmania
Locked Bag 1322
Launceston
TAS
7250
Country 70286 0
Australia
Phone 70286 0
+61 3 6324 5487
Fax 70286 0
+61 3 6324 3658
Email 70286 0
[email protected]
Contact person for public queries
Name 70287 0
A/Prof Andrew Williams
Address 70287 0
University of Tasmania
Locked Bag 1322
Launceston
TAS
7250
Country 70287 0
Australia
Phone 70287 0
+61 3 6324 5487
Fax 70287 0
+61 3 6324 3658
Email 70287 0
[email protected]
Contact person for scientific queries
Name 70288 0
A/Prof Andrew Williams
Address 70288 0
University of Tasmania
Locked Bag 1322
Launceston
TAS
7250
Country 70288 0
Australia
Phone 70288 0
+61 3 6324 5487
Fax 70288 0
+61 3 6324 3658
Email 70288 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13726Study protocol    371807-(Uploaded-15-06-2021-14-18-38)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving physical activity, pain and function in patients waiting for hip and knee arthroplasty by combining targeted exercise training with behaviour change counselling: Study protocol for a randomised controlled trial.2018https://dx.doi.org/10.1186/s13063-018-2808-z
EmbaseEffect of combined exercise training and behaviour change counselling versus usual care on physical activity in patients awaiting hip and knee arthroplasty: A randomised controlled trial.2022https://dx.doi.org/10.1016/j.ocarto.2022.100308
N.B. These documents automatically identified may not have been verified by the study sponsor.