Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001101572
Ethics application status
Approved
Date submitted
29/09/2015
Date registered
20/10/2015
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a walking programme for people with symptoms of hip/knee osteoarthritis
Scientific title
Pedometer-driven walking programme to improve physical activity levels in community-dwelling individuals with symptoms of hip/knee osteoarthritis – A feasibility study
Secondary ID [1] 287529 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 296294 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296683 296683 0 0
Physiotherapy
Musculoskeletal 296684 296684 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 (Tailored physiotherapy intervention - combination of exercise and manual therapy for six weeks): The exercise and manual therapy will be modified to address the individuals’ impairments (as per the assessment), aimed at improving/modifying the quality of joint movement and pain modulation.
The exercise therapy will consist of a 20 minute supervised exercise programme including neuromuscular control exercises in weight bearing, muscle stretching and strengthening exercises. Exercises will be tailored according to the clinical presentation and, an individualised home programme will be prescribed. The targets to achieve will be discussed with the participant. and set accordingly. Participants will be encouraged to carry out the set of exercises at least once a day for about 30 minutes and maintain an exercise diary to self-monitor exercise behaviour and adherence. The home programme will be reviewed during every visit and progressed as appropriate to the participant.
Manual therapy is operationally defined as the external force applied to the joint by a physiotherapist. Parameters of force such as magnitude of force, frequency and direction of treatment will be informed by clinical presentation and informed by the evidence. The manual therapy session will approximately be 20 minutes long.
The supervised exercise and manual therapy will occur in the same session, with one session/week for six weeks. After completion of the six-week intervention programme, participants will be encouraged to continue the home programme for further six weeks. In total, the home programme will take place for 12 weeks.

Group 2 (Tailored physiotherapy and a tailored physical activity programme): This group will receive a physical activity programme in addition to the tailored physiotherapy intervention (supervised exercise, manual therapy and home programme).
The physical activity programme consists of a pedometer-driven walking programme based on the self-regulation theory. The intervention includes self-monitoring of the physical activity (step count) and a weekly goal setting to increase the level of physical activity by at least 5%. Participants will be required to walk at least 30 minutes/day in one-week period to meet the recommended international guidelines for physical activity. The physiotherapist delivering the intervention will have a facilitatory role in increasing the physical activity levels for the first six weeks. The therapist will review the pedometer logbook and provide feedback on the physical activity levels when the participant attends for treatment. For a further six weeks the participants will be encouraged to continue the pattern of increasing physical activity and reinforced with a weekly follow-up phone call, which will be approximately 15 minutes long.
Intervention code [1] 292923 0
Rehabilitation
Intervention code [2] 293007 0
Treatment: Other
Comparator / control treatment
Group 3 (Usual care): Participants of this group will not receive active intervention from the research team and will be asked to continue their usual activities. But they will receive a one-off education/advice and pedometers at the start of the study/intervention programme. Participants may receive care from their regular care giver which includes a General Practitioner or any other health care personnel. Participants may also choose to be involved in a physical activity programme on their own. For the purposes of the study, these information will be recorded.

All three groups will receive general education about self-management of the condition and engagement in physical activity via pamphlets. Participants of all three groups will also receive a pedometer and the instructions to use them.
Control group
Active

Outcomes
Primary outcome [1] 296188 0
Adherence to the intervention: Adherence to the intervention programme will be evaluated from the exercise diary and pedometer logs.
Timepoint [1] 296188 0
At 6 weeks (conclusion of the intervention programme) and at 12 weeks.
Primary outcome [2] 296301 0
Percentage of recruitment, retention and attrition to the intervention.
This is a composite primary measure of feasibility to assess the ability to recruit required sample size, ability to retain the recruited sample during the intervention phase and the ability to follow-up at least 90% of the participants.
The study records will reviewed at the end of the study to determine the percentages.
Timepoint [2] 296301 0
At 12 weeks.
Primary outcome [3] 296302 0
Acceptability of the intervention: Acceptability will be determined by a survey exploring participants’ opinions at the completion of the study (after 12 weeks) using a five point numerical scale.
Any adverse events due to the intervention will also be recorded and evaluated.
Timepoint [3] 296302 0
At 12 weeks
Secondary outcome [1] 317749 0
Physical activity levels:
Objective physical activity will be measured using Yamex Ex210 Pedometers.
Subjective physical activity will be measured using the New Zealand Physical Activity Questionnnaire
Timepoint [1] 317749 0
At baseline, 6-weeks and 12 weeks.
Secondary outcome [2] 317750 0
Exercise self-efficacy:
The 12-item exercise confidence questionnaire to determine the self-efficacy towards physical activity.
Timepoint [2] 317750 0
At baseline, 6-weeks and 12-weeks.
Secondary outcome [3] 317760 0
Western Ontario and McMaster Universities Arthritis Index (WOMAC): A condition-specific assessment tool that has the sensitivity to quantify small effects of an intervention.
Timepoint [3] 317760 0
At baseline, 6-weeks and 12-weeks.

Eligibility
Key inclusion criteria
All potential participants aged 40-75 years who satisfy American College of Rheumatology clinical criteria for classification of hip/knee OA will be considered for inclusion. Additionally participants should not be regularly physically active (less than 7500 steps/day), but able to walk for at least 10 minutes will only be considered for the study.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they had undergone any hip/knee surgery within the past 12 months, have a history of lower limb joint replacement, have had an intra-articular steroid injection within the past 12 months, have history of inflammatory/systemic arthritis. Participants with a hip/knee joint pain from a source other than the respective joint (confirmed by clinical examination) will also 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)
Potential participants for this study will be identified by a population survey of people living in Greater Dunedin, New Zealand. A random sample of 1440 people from New Zealand census (Dunedin) comprising of adults, aged between 40 and 75 years have previously been invited to participate in a survey on the symptoms of hip and knee OA. With an anticipated response rate of 40%, a total return of 576 responses is expected from the survey. The survey will be oversampled to ensure inclusion of individuals who identify as Maori in the electoral roll. It is anticipated that at least three categories of participants will be identified from the survey.
A. Category 1: Participants with possible OA - current hip/knee pain but no OA diagnosis
B. Category 2: Participants with hip/knee OA diagnosed by GP or specialist with or without imaging
C. Category 3: Participants with (i) No current OA/ no hip or knee pain (ii) Ongoing pain in hip/knee other than OA which is diagnosed by a GP or a specialist.

From the pool of participants in Category 1, participants who have expressed interest to participate in the intervention phase will be invited to undergo a screening procedure for the confirmation of the osteoarthritis of the hip/knee joints. A total of 60 participants will be recruited to participate in the study, with n=20 in each study group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals satisfying the criteria for participation will complete the baseline assessment and then be randomly allocated to one of the three groups by the trial administrator who will not be involved in the intervention and/or administration of outcome measures. A computer-generated block randomisation will be generated prior to the commencement of the study by the trial administrator.
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
Research assistant administering the outcome measures will be blinded to the intervention group.
Researcher/s involved in data analysis will be blinded to the intervention group.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of participants required for this study was determined based on previous sample size recommendations for feasibility and pilot studies (Hertzog 2008; Julious SA and Patterson SD 2004).

Feasibility of the study will be determined from the primary outcome measures.

The means (with 95% confidence intervals), standard deviations and variance will be determined for all secondary measures. A preliminary analysis to determine the effect of intervention between the groups in secondary measures at each time point will be obtained using One-way ANOVA.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/12/2015
Actual
3/03/2016
Date of last participant enrolment
Anticipated
30/12/2016
Actual
9/01/2018
Date of last data collection
Anticipated
Actual
22/02/2018
Sample size
Target
60
Accrual to date
Final
33
Recruitment outside Australia
Country [1] 7182 0
New Zealand
State/province [1] 7182 0
Dunedin, Christchurch and Wellington

Funding & Sponsors
Funding source category [1] 292129 0
Charities/Societies/Foundations
Name [1] 292129 0
Otago Medical Research Foundation Inc.
Country [1] 292129 0
New Zealand
Primary sponsor type
University
Name
Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago
Address
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 290806 0
None
Name [1] 290806 0
Address [1] 290806 0
Country [1] 290806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293590 0
Health and Disability Ethics Committee
Ethics committee address [1] 293590 0
Ethics committee country [1] 293590 0
New Zealand
Date submitted for ethics approval [1] 293590 0
22/10/2015
Approval date [1] 293590 0
10/11/2015
Ethics approval number [1] 293590 0
Ethics committee name [2] 293591 0
University of Otago Human Ethics Committee (For survey phase)
Ethics committee address [2] 293591 0
Ethics committee country [2] 293591 0
New Zealand
Date submitted for ethics approval [2] 293591 0
09/10/2015
Approval date [2] 293591 0
04/05/2015
Ethics approval number [2] 293591 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59026 0
Dr Prasath Jayakaran
Address 59026 0
325 Great King Street, School of Physiotherapy, University of Otago, Dunedin 9016
Country 59026 0
New Zealand
Phone 59026 0
+6434798822
Fax 59026 0
Email 59026 0
[email protected]
Contact person for public queries
Name 59027 0
David Jackson
Address 59027 0
325 Great King Street, School of Physiotherapy, University of Otago, Dunedin 9016
Country 59027 0
New Zealand
Phone 59027 0
+6434798822
Fax 59027 0
Email 59027 0
[email protected]
Contact person for scientific queries
Name 59028 0
Prasath Jayakaran
Address 59028 0
325 Great King Street, School of Physiotherapy, University of Otago, Dunedin 9016
Country 59028 0
New Zealand
Phone 59028 0
+6434798822
Fax 59028 0
Email 59028 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
The information about data sharing was not included in the ethics application and therefore the Participant Information sheet/consent form did not include any details with regard to this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
551Other    This can be obtained from the trial's Principal In... [More Details]



Results publications and other study-related documents

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