Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000817347
Ethics application status
Approved
Date submitted
29/05/2017
Date registered
5/06/2017
Date last updated
5/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
App-Based Supplemental Exercise During Inpatient Orthopaedic Rehabilitation Increases Activity Levels: A Pilot Randomised Control Trial
Scientific title
App-Based Supplemental Exercise During Inpatient Orthopaedic Rehabilitation Increases Activity Levels: A Pilot Randomised Control Trial
Secondary ID [1] 292041 0
None
Universal Trial Number (UTN)
U1111-1197-0568
Trial acronym
AERO
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Joint Replacement
 303497 0
Osteoarthritis 303498 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302917 302917 0 0
Other physical medicine / rehabilitation
Musculoskeletal 302952 302952 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals admitted for orthopaedic rehabilitation randomised to either usual care orthopaedic 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 were 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 had a de-identified login created by the research team and an individualised exercise program was uploaded to a Royal Rehab Apple iPad Air 2 that was provided to the participants for the duration of their admission. The set programs for orthopaedic conditions were designed by the principal physiotherapy researcher in conjunction with the treating physiotherapy team. Exercise programs included the following exercise types; range of motion, stretching, strengthening and practice of everyday tasks e.g. walking or standing up. The time that participants logged onto their exercise account, repetitions undertaken and difficulties encountered were remotely monitored by the treating therapist and principal investigators. After allocation, the intervention participants received one session at the commencement of their program to learn to use the App and ongoing support to both groups was provided, as needed, to the participants by the research assistant.
Intervention code [1] 298219 0
Treatment: Devices
Intervention code [2] 298263 0
Rehabilitation
Comparator / control treatment
The control group received usual care in addition to scheduled therapy. This included encouragement to undertake supplemental exercise, either with instructions on paper or verbally if the therapist chose to prescribe this. All control participants received a paper diary to record the amount and number of repetitions of supplemental exercise from the research team, which was collected by the research assistant on discharge.
Control group
Active

Outcomes
Primary outcome [1] 302304 0
Qualitative data obtained from survey designed specifically for this study and administered at the completion of inpatient rehabilitation to assess satisfaction with the App.
Timepoint [1] 302304 0
At admission and discharge from inpatient rehabilitation unit
Primary outcome [2] 302305 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 [2] 302305 0
At admission and discharge from inpatient rehabilitation unit
Secondary outcome [1] 335406 0
6MWT
Timepoint [1] 335406 0
At admission and discharge from inpatient rehabilitation unit
Secondary outcome [2] 335407 0
Total length of stay as assessed from a review of medical records
Timepoint [2] 335407 0
At discharge from inpatient rehabilitation unit
Secondary outcome [3] 335579 0
10MWT
Timepoint [3] 335579 0
At admission and discharge
Secondary outcome [4] 335580 0
Time Up and Go
Timepoint [4] 335580 0
At admission and discharge
Secondary outcome [5] 335581 0
Total amount of inpatient therapy hours as assessed from a review of inpatient physiotherapy timetables
Timepoint [5] 335581 0
At discharge

Eligibility
Key inclusion criteria
Participants were included if they were inpatients undergoing usual-care orthopaedic rehabilitation, aged over 18 years of age, able to consent, had been admitted with an orthopaedic diagnosis, and were willing to use or be educated on the use of the tablet device and had no medical contraindications to a supplemental exercise program. If the individual was unable to provide consent due to cognitive impairment defined as a Mini Mental State Examination (MMSE) score less than 24/30, they were not 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 randomised according to a number drawn from a concealed box
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consecutive 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
Actual
13/01/2017
Date of last participant enrolment
Anticipated
Actual
17/02/2017
Date of last data collection
Anticipated
Actual
24/02/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8210 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment postcode(s) [1] 16269 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 296573 0
Hospital
Name [1] 296573 0
Royal Rehab Foundation
Country [1] 296573 0
Australia
Primary sponsor type
Hospital
Name
Royal Rehab Hospital
Address
235 Morrison Rd Ryde NSW 2112
Country
Australia
Secondary sponsor category [1] 295530 0
University
Name [1] 295530 0
Macquarie University
Address [1] 295530 0
Faculty of Medicine and Health Sciences
G815 75 Talavera Rd
Macquarie University
NSW, 2109, Australia
Country [1] 295530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297790 0
Northern Sydney Local Health District
Ethics committee address [1] 297790 0
NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 297790 0
Australia
Date submitted for ethics approval [1] 297790 0
11/11/2016
Approval date [1] 297790 0
12/12/2016
Ethics approval number [1] 297790 0
HREC/15/HAWKE/444

Summary
Brief summary
Objective: To investigate whether an App-based supplemental exercise program in orthopaedic rehabilitation will be feasible and acceptable to participants, increase activity levels and improve functional outcomes.
Design: Single-centre, single-blind pilot randomised control trial
Setting: Inpatient private general rehabilitation unit
Participants: Twenty individuals admitted for orthopaedic rehabilitation over four week duration.
Intervention: Participants were randomised to receive supplemental exercise via an App (PTPalTM) on a tablet device additional to usual care or usual care alone.
Main Outcome Measures: Primary outcome measures were participant satisfaction with App-based supplemental exercise, total repetitions of each activity and time in supplemental exercise programs. Secondary measures were 10 Metre Walk Test (10MWT); 6 Minute Walk Test (6MWT); Timed Up and Go (TUG); Functional Independence Measure and length of stay assessed by a blinded assessor.
Trial website
None
Trial related presentations / publications
None
Public notes
Attachments [1] 1757 1757 0 0
/AnzctrAttachments/373016-Letter - HREC FINAL approval - HREC Exec meeting OSS 12 December 2016 - RESP16297 (1).pdf (Ethics approval)

Contacts
Principal investigator
Name 75122 0
Dr Tram Bui
Address 75122 0
Royal Rehab
235 Morrison Rd Ryde NSW 2112
Country 75122 0
Australia
Phone 75122 0
+61 2 9808 9222
Fax 75122 0
+61 2 9808 7215
Email 75122 0
[email protected]
Contact person for public queries
Name 75123 0
Tram Bui
Address 75123 0
Royal Rehab
235 Morrison Rd Ryde NSW 2112
Country 75123 0
Australia
Phone 75123 0
+61 2 9808 9222
Fax 75123 0
+61 2 9808 7215
Email 75123 0
[email protected]
Contact person for scientific queries
Name 75124 0
Tram Bui
Address 75124 0
Royal Rehab
235 Morrison Rd Ryde NSW 2112
Country 75124 0
Australia
Phone 75124 0
+61 2 9808 9222
Fax 75124 0
+61 2 9808 7215
Email 75124 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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseApp-based supplemental exercise during inpatient orthopaedic rehabilitation increases activity levels: A pilot randomised control trial.2019https://dx.doi.org/10.1186/s40814-019-0430-9
N.B. These documents automatically identified may not have been verified by the study sponsor.