Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001011572
Ethics application status
Approved
Date submitted
3/08/2015
Date registered
28/09/2015
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient adherence to physiotherapy exercise programs: effect of a web-based exercise programming system compared to usual physiotherapy exercise delivery.
Scientific title
Effect of a web-based exercise programming system on exercise adherence levels compared to usual exercise delivery in people receiving physiotherapy for a musculoskeletal condition
Secondary ID [1] 285687 0
Nil
Universal Trial Number (UTN)
U1111-1164-1937
Trial acronym
PANTHER study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck pain 293540 0
Trunk pain 296007 0
Back pain 296018 0
Upper limb pain 296019 0
Lower limb pain 296020 0
Sports Injuries 296021 0
Osteoarthritis 296022 0
Rheumatoid Arthritis 296023 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293815 293815 0 0
Physiotherapy
Musculoskeletal 296299 296299 0 0
Other muscular and skeletal disorders
Injuries and Accidents 296300 296300 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 3-week intervention of usual physiotherapy treatment with Physitrack: individualised care according to the participant's presenting diagnosis including an exercise program delivered using the web-based exercise programming system (Physitrack).

The Physitrack group receives their exercise program through the physitrack web based programming system.

Physitrack is a web based programming system with an extensive library of videos of a range of exercises. The treating physiotherapist determines the appropriate exercises for each of their patients, including the number of repetitions and sets, frequency, duration and exercise progression. The patients can then access their exercise program through the web page or via an App. It can be updated accordingly by the physiotherapist.

The patients physiotherapist will be able to monitor their adherence to the exercises as the patient can interact with the app or online, and their exercise program and indicate how many repetitions they did of the exercise. Plus the patient can also view their adherence online and via the app.
Intervention code [1] 290626 0
Rehabilitation
Intervention code [2] 292697 0
Treatment: Other
Comparator / control treatment
A 3-week intervention of usual physiotherapy treatment: individualised care according to the participant's presenting diagnosis including an exercise program delivered according to usual non web-based methods of the treating physiotherapist. For example, this could take the form of individualised hand written instructions, semi-structured/individualised typed handouts, or standardised/general handouts.

The patients physiotherapist will monitor their adherence as per their usual practice. This will depend upon the physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 293602 0
Adherence level to an exercise program. Self-reported adherence level to the prescribed exercise program in the previous 3 week period; 11-point numeric rating scale.
Timepoint [1] 293602 0
3 weeks
Secondary outcome [1] 311453 0
Patient satisfaction with the delivery of the exercise program - 11-point numeric rating scale
Timepoint [1] 311453 0
3 weeks
Secondary outcome [2] 311454 0
Patient-perceived confidence to perform exercises - 11-point numeric rating scale
Timepoint [2] 311454 0
3 weeks

Eligibility
Key inclusion criteria
Newly presenting patient

Aged 18 years and over

Any musculoskeletal condition (e.g. back and neck pain, osteoarthritis, inflammatory arthritis such as rheumatoid, sports injuries, other injuries) that the treating physiotherapist (on initial assessment) expects to require at least a 3-week exercise program as part of the physiotherapy treatment

Current email address and access to a computer, tablet device or smart phone

Adequate level of written and spoken English to be able to complete online surveys and access a website written in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
On the waiting list, planning, or likely to require (in the opinion of the treating physiotherapist) surgery in the next 3 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)
All patients over 18 years of age with a musculoskeletal condition attending an initial session with a participating physiotherapist will be asked to complete a screening survey in reception before they are seen by the treating therapist. Eligible consenting participants will complete baseline measures and following will be randomised into the study at the initial consult by the treating physiotherapist using the National Health and Medical Research Council’s Clinical Trials Centre Randomisation interactive voice response system. Allocation concealment will be obtained using this. The schedule will be prepared using minimisation stratified for physiotherapist and the affected body region to be treated (upper limb, lower limb, and spine).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the NHMRC Clinical Trials Centre. Randomisation will be by minimisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
All potential participants will be informed that their physiotherapist is participating in a study that will compare different ways of delivering exercise programs to determine which is better. They will not be specifically informed about the nature of the web-based program and thus will remain blinded to the different treatment arms of the study as well as the specific hypothesis of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Measured at 3 weeks post-intervention. Given the number of factors that affect adherence, and that Physitrack will only target some of these factors, we expect that Physitrack will have a small effect on patient adherence. Thus, to detect an effect size of 0.35 with 80% power and a significance level of 0.05, and controlling for stratifying variables of physiotherapist and body region we require 129 patients per arm (258 in total). To allow for 15% attrition, 152 per arm (304) in total will be recruited.

Data will be analysed in a blinded manner with p values less that 0.05 considered significant. Demographic characteristics will be inspected to assess comparability of treatment groups. These variables will also be examined for those participants who withdraw from the study and those who remain.
Descriptive statistics will be presented for each group as means or medians (standard deviation, inter-quartile ranges). Continuous outcomes will be compared between the two groups using between group analysis of variance (ANOVA) controlling for stratifying variables of physiotherapist and body region with significant level set at 0.05. Proportional odds models will compare improvement between groups based on perceived ratings of change. Model diagnostic checks will utilise residual plots.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2015
Actual
15/10/2015
Date of last participant enrolment
Anticipated
Actual
26/05/2017
Date of last data collection
Anticipated
Actual
4/08/2017
Sample size
Target
304
Accrual to date
Final
305
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 6972 0
New Zealand
State/province [1] 6972 0
Auckland

Funding & Sponsors
Funding source category [1] 290254 0
Commercial sector/Industry
Name [1] 290254 0
Physitrack Limited
Country [1] 290254 0
United Kingdom
Funding source category [2] 290257 0
Government body
Name [2] 290257 0
National Health and Medical Research Council
Program Grant 631717
Country [2] 290257 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street,
Parkville
Victoria 3010
Country
Australia
Secondary sponsor category [1] 288961 0
None
Name [1] 288961 0
Address [1] 288961 0
Country [1] 288961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291954 0
University of Melbourne Human Research Ethics Commitee
Ethics committee address [1] 291954 0
Melbourne Research
The University of Melbourne
Level 5 Alan Gilbert Building
241-255 Grattan Street,
Parkville
VIC 3010
Ethics committee country [1] 291954 0
Australia
Date submitted for ethics approval [1] 291954 0
Approval date [1] 291954 0
15/09/2014
Ethics approval number [1] 291954 0
1442773.1

Summary
Brief summary
Exercise is an integral component of the conservative management of most musculoskeletal conditions. However, adherence to exercises is often low and this impacts on treatment effectiveness. The aim of this randomised controlled trial is to evaluate whether the addition of a web-based system, Physitrack, to usual physiotherapy treatment improves patient adherence levels to exercises compared to the usual non web-based methods physiotherapists use to deliver exercise programs to people with musculoskeletal conditions. Secondary aims are to evaluate whether Physitrack improves patient satisfaction with the delivery of an exercise program and whether patient confidence changes with Physitrack.

The primary hypothesis is: The level of patient-reported adherence to a prescribed exercise program will be greater in the group receiving Physitrack in addition to usual physiotherapy treatment (Physitrack group) than in the group receiving non web-based usual physiotherapy treatment alone (Usual care group) after 3 weeks.

Secondary hypotheses are: i) The level of patient satisfaction with the delivery of the prescribed exercise program will be greater in the Physitrack group than in the group receiving non web-based usual care after 3 weeks; and ii) The level of patient confidence with exercises will be greater in the Physitrack group than in the group receiving non web-based usual care after 3 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52842 0
Prof Kim Bennell
Address 52842 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
University of Melbourne
Alan Gilbert Building
161 Barry Street
Parkville
VIC 3010
Country 52842 0
Australia
Phone 52842 0
+ 61 3 83444135
Fax 52842 0
Email 52842 0
[email protected]
Contact person for public queries
Name 52843 0
Mrs Charlotte Marshall
Address 52843 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
University of Melbourne
Alan Gilbert Building
161 Barry Street
Parkville
VIC 3010
Country 52843 0
Australia
Phone 52843 0
+61 3 83440485
Fax 52843 0
Email 52843 0
[email protected]
Contact person for scientific queries
Name 52844 0
Prof Kim Bennell
Address 52844 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
University of Melbourne
Alan Gilbert Building
161 Barry Street
Parkville
VIC 3010
Country 52844 0
Australia
Phone 52844 0
+ 61 3 83444135
Fax 52844 0
Email 52844 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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