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Trial registered on ANZCTR


Registration number
ACTRN12616001161415
Ethics application status
Approved
Date submitted
21/08/2016
Date registered
25/08/2016
Date last updated
5/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The utility of pedometers in improving mobility outcomes in inpatient rehabilitation - pilot randomised control trial (RCT)
Scientific title
The utility of pedometers in improving mobility outcomes in inpatient rehabilitation - pilot RCT
Secondary ID [1] 289986 0
Nil known
Universal Trial Number (UTN)
Trial acronym
UP Mobility study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
reduced mobility 299991 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299884 299884 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pedometer intervention arm: Pedometer intervention in addition to usual care.
Usual care: received by both groups. This includes individualised exercise prescribed by a physiotherapist, carried out by either a physiotherapist or allied health assistant (AHA) in individual and/or group settings. In addition, all participants receive an independent exercise programme with 3-6 exercises that they are encouraged to carry out independently and with supervision as required from family, visitors and staff. All eligible participants will have walking included as an exercise in this program. All participants are provided with a daily exercise recording sheet for this program weekly.
Pedometer intervention: Participants randomised into the intervention group will receive a Yamax Digiwalker SW200 pedometer (Yamax Corp., Tokyo, Japan). They will be instructed to wear it on the waist band, preferably on a less affected leg. It will be worn for all waking hours once a participant is dressed. It will be taken off when participants change into their night clothes. Those in the pedometer intervention arm will be asked to record the number of steps taken at the end of the day as displayed on the pedometer. Family and nursing staff will be asked to assist. The feedback to participants, family and staff will be to increase number of steps taken every day. No specific target will be given to limit increasing workload of ward physiotherapist.
Participants will wear the pedometer for the duration of their stay as long as they are a rehabilitation patient. Their adherence will be monitored by staff daily. Activpal step data will also be compared to pedometer data and will show usage in the first 2 weeks.
Intervention code [1] 295681 0
Rehabilitation
Intervention code [2] 295722 0
Treatment: Devices
Comparator / control treatment
Usual care control arm: usual care in addition to blinded pedometer use
Usual care: received by both groups. This includes individualised exercise prescribed by a physiotherapist, carried out by either a physiotherapist or allied health assistant (AHA) in individual and/or group settings. In addition, all participants receive an independent exercise programme with 3-6 exercises that they are encouraged to carry out independently and with supervision as required from family, visitors and staff. All eligible participants will have walking included as an exercise in this program. All participants are provided with a daily exercise recording sheet for this program weekly.
Control Arm: Participants will be asked to record an estimate of distance walked each day on exercise recording sheet. Family and nursing staff will be asked to assist. They will be provided with information on common walk distances at JLGRU as measured by a ward plan. The feedback to participants, family and staff will be to increase the total distance walked each day. No specific target will be given to limit increasing workload of ward physiotherapist. They will also be provided with a pedometer that will be fixed shut. Support staff will record number of steps taken early in the morning for the previous day and fix shut again.
Participants will wear the pedometer for the duration of their stay as long as they are a rehabilitation patient.
Control group
Active

Outcomes
Primary outcome [1] 299362 0
mobility measured by De Morton Mobility Index (DEMMI)
Timepoint [1] 299362 0
All participants will undergo two measurements sessions: one on entry into the study (baseline assessment), and one prior to discharge of rehabilitation (pre discharge), by a physiotherapist blinded to group allocation. Baseline assessments will be completed prior to randomization.
Secondary outcome [1] 326926 0
gait speed assessed using the 10 metre walk test (10MWT)
Timepoint [1] 326926 0
All participants will undergo two measurements sessions: one on entry into the study (baseline assessment), and one prior to discharge of rehabilitation (pre discharge), by a physiotherapist blinded to group allocation. Baseline assessments will be completed prior to randomization.
Secondary outcome [2] 326927 0
adapted pedometer satisfaction scale using 5 point Likert scales measuring level of helpfulness and enjoyment.
Timepoint [2] 326927 0
prior to discharge from rehabilitation (pre discharge)
Secondary outcome [3] 326928 0
All participants will have their activity monitored for the first week they are enrolled on the study using accelerometer (ActivPal – PAL technologies, Glasgow, United Kingdom) which will measure time upright and steps taken.
Timepoint [3] 326928 0
From baseline assessment for the first week
Secondary outcome [4] 326929 0
Functional independence measured by functional independence measure (FIM)
Timepoint [4] 326929 0
On admission, on recruitment to the study, and on discharge from the ward
Secondary outcome [5] 326930 0
steps taken measured by pedometer
Timepoint [5] 326930 0
assessed daily from baseline to pre discharge assessment

Eligibility
Key inclusion criteria
Eligible participants will be adults admitted to an inpatient rehabilitation ward with reduced mobility (relative to their premorbid mobility) with a clinician-assessed capacity for improvement in mobility. They will be eligible once they can walk a minimum of 3 metres on the ward, with or without the assistance of one person, with or without a walking aid.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be: insufficient English language skills to participate in rehabilitation and no available interpreter; severe receptive aphasia or inability to communicate; a medical condition precluding exercise (unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aortic aneurysm or a weight-bearing restriction such as non or touch weight bearing); not admitted under rehabilitation i.e. nursing home type; expected discharge date less than one week after recruitment to the study.

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)
Baseline assessments will be completed prior to randomization. Allocation into intervention or control group will occur using a computer-generated randomisation. Generation of the randomization sequence will be generated by a researcher not involved in recruitment or assessment. Group allocation will be concealed using consecutively-numbered opaque envelopes, opened after completion of assessment in the presence of the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation into intervention or control group will occur using a computer-generated block randomisation (http://www.randomization.com/).
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
The sample size for this study was based on a previous study conducted in a subacute rehabilitation setting with a similar cohort (de Morton & Lane, 2010). It showed the median De Morton Mobility Index (DEMMI) score was 30.2 with a standard deviation of 16.7. Sample size estimation was based on the group achieving a minimal detectable change and clinically meaningful change of 10.5 points on the DEMMI. With a one tailed significance threshold of 0.05 and a power of 80%, 32 participants were required in each group. To account for a 20% dropout rate, 78 participants will be recruited for this study.
The primary outcomes will be analysed on an intention to treat basis. Between group differences in the primary outcome measure, DEMMI, will be analysed using independent t tests if normally distributed, otherwise Mann Whitney tests will be used. The level of significance will be set at 0.05.
Between group differences at discharge for secondary outcome measures, gait speed, time spent upright, discharge Function Independence Measure (FIM) score, steps taken with Activpal, steps taken with pedometer, perceived levels of helpfulness and enjoyment of pedometer use will be analysed using independent t tests. If data is not normally distributed, Mann Whitney tests will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/11/2016
Actual
10/11/2016
Date of last participant enrolment
Anticipated
30/11/2017
Actual
22/02/2018
Date of last data collection
Anticipated
30/11/2017
Actual
9/03/2018
Sample size
Target
78
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 6516 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 14082 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 294357 0
Hospital
Name [1] 294357 0
Launceston General Hospital
Country [1] 294357 0
Australia
Primary sponsor type
Individual
Name
Dr Chris Barr
Address
Room 51, C Block
Repatriation General Hospital
Daws Road
Daw Park
Adelaide SA 5041
Country
Australia
Secondary sponsor category [1] 293197 0
Individual
Name [1] 293197 0
Amy Atkins
Address [1] 293197 0
John L Grove Rehabilitation Unit
Launceston General Hospital
Charles Street
Launceston
TAS 7250
Country [1] 293197 0
Australia
Secondary sponsor category [2] 293198 0
Individual
Name [2] 293198 0
Mr John Cannell
Address [2] 293198 0
Physiotherapy Department
Launceston General Hospital
Charles Street
Launceston
TAS 7250
Country [2] 293198 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295775 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 295775 0
Ethics committee country [1] 295775 0
Australia
Date submitted for ethics approval [1] 295775 0
09/06/2016
Approval date [1] 295775 0
08/08/2016
Ethics approval number [1] 295775 0
H0015819

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

Contacts
Principal investigator
Name 68434 0
Dr Chris Barr
Address 68434 0
Room 51, C Block
Repatriation General Hospital
Daws Road
Daw Park
Adelaide SA 5041
Country 68434 0
Australia
Phone 68434 0
+61 8 82751018
Fax 68434 0
Email 68434 0
chris.barr@flinders.edu.au
Contact person for public queries
Name 68435 0
Amy Atkins
Address 68435 0
John L Grove Rehabilitation Unit
Launceston General Hospital
Charles Street
Launceston TAS 7250
Country 68435 0
Australia
Phone 68435 0
+61 3 67776777
Fax 68435 0
Email 68435 0
amy.rathjen@ths.tas.gov.au
Contact person for scientific queries
Name 68436 0
Chris Barr
Address 68436 0
Room 51, C Block
Repatriation General Hospital
Daws Road
Daw Park
Adelaide SA 5041
Country 68436 0
Australia
Phone 68436 0
+61 8 82751018
Fax 68436 0
Email 68436 0
chris.barr@flinders.edu.au

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
No additional documents have been identified.