Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001576314
Ethics application status
Approved
Date submitted
29/10/2017
Date registered
24/11/2017
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Date results information initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
App-Based Supplemental Exercise During Inpatient Rehabilitation Increases Activity Levels: A Randomised Control Trial
Scientific title
App-Based Supplemental Exercise During Inpatient Rehabilitation Increases Activity Levels: A Randomised Control Trial
Secondary ID [1] 293238 0
Nil
Universal Trial Number (UTN)
U1111-1204-3912
Trial acronym
AERO
Linked study record
Pilot study completed: ACTRN12617000817347

Health condition
Health condition(s) or problem(s) studied:
Physical Medicine / Rehabilitation 305453 0
Osteoarthritis 305454 0
Neurological Conditions 305526 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304592 304592 0 0
Physiotherapy
Musculoskeletal 304765 304765 0 0
Osteoarthritis
Neurological 304768 304768 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals admitted for inpatient rehabilitation will be randomised to either usual care rehabilitation program or to usual care with an App-based supplemental exercise program, delivered via an App downloaded to a tablet device (PTPal).

The intervention group receive supplementary exercise program designed by their treating therapist and uploaded to PTPal and accessed via a tablet device in addition to usual care. Participants allocated to the intervention group were provided with a tablet device for the duration of their inpatient program. Both intervention and control group receive supplemental exercises but intervention group uses an app based program for delivery and monitoring of these exercises.

Exercise programs for the intervention participants are individually designed by the treating therapist.

PTPal is a care delivery App that allows clinicians and therapists to send participating individuals digital prescriptions of exercises, activities and surveys, directly to the a mobile or tablet device.

Participants will have a de-identified login created by the research team and an individualised exercise program that will be uploaded to a Royal Rehab Apple iPad Air 2 that will be provided to the participants for the duration of their admission. The set programs for orthopaedic conditions will be designed by the principal physiotherapy researcher in conjunction with the treating physiotherapy team. Exercise programs will be indivdualised according to the patients' conditions. The time that participants log onto their exercise account, repetitions undertaken and difficulties encountered will be remotely monitored by the treating therapist and principal investigators. After allocation, the intervention participants will receive one session at the commencement of their program to learn to use the App and ongoing support to both groups will be provided, as needed, to the participants by the research assistant.
Intervention code [1] 299496 0
Treatment: Devices
Intervention code [2] 299497 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care in addition to scheduled therapy. This includes encouragement to undertake supplemental exercise, either with instructions on paper or verbally if the therapist chooses to prescribe this. All control participants will receive a paper diary to record the amount and number of repetitions of supplemental exercise from the research team, which will be collected by the research assistant on discharge.
Control group
Active

Outcomes
Primary outcome [1] 303811 0
Composite quantitative data from App from intervention participants and diaries from controls regarding the amount of time, and number of repetitions in supplemental exercise.
Timepoint [1] 303811 0
At admission and discharge from inpatient rehabilitation unit
Primary outcome [2] 303813 0
Total length of stay as assessed from a review of medical records
Timepoint [2] 303813 0
At discharge from inpatient rehabilitation unit
Secondary outcome [1] 340210 0
6MWT
Timepoint [1] 340210 0
At admission and discharge from inpatient rehabilitation unit
Secondary outcome [2] 340211 0
10MWT
Timepoint [2] 340211 0
At admission and discharge from inpatient rehabilitation unit
Secondary outcome [3] 340212 0
Timed Up and Go
Timepoint [3] 340212 0
At admission and discharge from inpatient rehabilitation unit
Secondary outcome [4] 375895 0
Functional Independence Measure (FIM)
Timepoint [4] 375895 0
At admission and discharge from inpatient rehabilitation unit

Eligibility
Key inclusion criteria
Participants will be recruited if they are inpatients undergoing usual-care rehabilitation, aged over 18 years of age, able to consent, had been admitted for inpatient rehabilitation, and are willing to use or be educated on the use of the tablet device and have no medical contraindications to a supplemental exercise program. Eligible participants must be undergoing rehabilitation in any diagnostic category (orthopaedic, neurological, reconditioning). If the individual is unable to provide consent due to cognitive impairment defined as a Mini Mental State Examination (MMSE) score less than 24/30, they will not be approached to take part in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment
Medical contraindication to supplemental exercise program

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)
Participants will be randomised according to a number drawn from a concealed box
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Odd/Even numbers drawn from concealed box
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
Independent T-Tests

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2017
Actual
15/01/2018
Date of last participant enrolment
Anticipated
1/04/2020
Actual
24/12/2018
Date of last data collection
Anticipated
28/04/2020
Actual
24/12/2018
Sample size
Target
126
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9295 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment postcode(s) [1] 17960 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 297867 0
Hospital
Name [1] 297867 0
Royal Rehab
Country [1] 297867 0
Australia
Primary sponsor type
Hospital
Name
Royal Rehab
Address
235 Morrison Rd
Ryde NSW 2112
Country
Australia
Secondary sponsor category [1] 296912 0
None
Name [1] 296912 0
Address [1] 296912 0
Country [1] 296912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298918 0
NSLHD Human Research Ethics Committee
Ethics committee address [1] 298918 0
NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 298918 0
Australia
Date submitted for ethics approval [1] 298918 0
05/09/2017
Approval date [1] 298918 0
19/10/2017
Ethics approval number [1] 298918 0
RESP/16/297

Summary
Brief summary
Objective: To investigate whether an App-based supplemental exercise program in inpatient rehabilitation will increase activity levels and improve functional outcomes and be acceptable to participants
Design: Single-centre, single-blind pilot randomised control trial
Setting: Inpatient private general rehabilitation unit
Participants: Up to 140 individuals admitted for inpatient rehabilitation over 3 month duration.
Intervention: Participants will be randomised to receive supplemental exercise via an App (PTPalTM) on a tablet device additional to usual care or usual care alone.
Main Outcome Measures: Total repetitions of each activity and time in supplemental exercise programs, participant satisfaction with App-based supplemental exercise. Secondary measures were 10 Metre Walk Test (10MWT); 6 Minute Walk Test (6MWT); Timed Up and Go (TUG); total amount of inpatient therapy hours, Functional Independence Measure and length of stay assessed by a blinded assessor.
Trial website
None
Trial related presentations / publications
None
Public notes
Attachments [1] 2150 2150 0 0
/AnzctrAttachments/373896-Letter - Approved AMENDMENT - HREC Exec Meeting 15 September 2017 - RESP16297.pdf (Ethics approval)

Contacts
Principal investigator
Name 78642 0
Dr Tram Bui
Address 78642 0
Royal Rehab
235 Morrison Rd
Ryde NSW 2112
Country 78642 0
Australia
Phone 78642 0
+61 2 9808 9222
Fax 78642 0
+61 2 9808 7215
Email 78642 0
[email protected]
Contact person for public queries
Name 78643 0
Dr Tram Bui
Address 78643 0
Royal Rehab
235 Morrison Rd
Ryde NSW 2112
Country 78643 0
Australia
Phone 78643 0
+61 2 9808 9222
Fax 78643 0
+61 2 9808 7215
Email 78643 0
[email protected]
Contact person for scientific queries
Name 78644 0
Dr Kate Scrivener
Address 78644 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Ground Floor, 75 Talavera Road
Macquarie University, NSW 2109
Country 78644 0
Australia
Phone 78644 0
*61 2 9850 2794
Fax 78644 0
None
Email 78644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified IPD of published results only
When will data be available (start and end dates)?
After publication to no end date determined
Available to whom?
Written requests from researchers only.
Available for what types of analyses?
For outcome measures
How or where can data be obtained?
Through principal author of any published papers


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.