Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001071213
Ethics application status
Approved
Date submitted
6/06/2018
Date registered
27/06/2018
Date last updated
13/10/2020
Date data sharing statement initially provided
13/10/2020
Date results information initially provided
13/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a mobility device as an assistive device to maintain and/or enhance mobility in older adults.
Scientific title
Evaluation of a mobility device as an assistive device to maintain and/or enhance mobility in older adults living in aged care facilities.
Secondary ID [1] 294964 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical mobility
 307961 0
Psychological wellbeing 307962 0
Condition category
Condition code
Physical Medicine / Rehabilitation 306996 306996 0 0
Other physical medicine / rehabilitation
Mental Health 306997 306997 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will evaluate the efficacy of a mobility device for use by older Australian adults living in aged care to improve mobility, from the perspective of the user and the aged care organisation.
The mobility device to be used in the trial is one that is used in America, that has not yet penetrated Australia, Asia or Europe, with four wheels, a seat and a frame to the side and front that enables the users to sit and propel themselves along, or stand and walk.
A RCT approach will be used to evaluate the effect and cost effectiveness of the mobility device with residents in an SA aged care organisation and will include an evaluation of the mobility device using a randomised control design measuring standard functional, movement behaviour and quality of life with validated assessment tools (to be assessed at baseline and following 12 weeks' use).
Physiotherapists in the aged care organisations will identify residents who could benefit from mobility exercise. These residents will be invited to participate in the trial.
The participants that are randomised into the intervention group will participate in a 6-week block of mobility sessions with a health professional at the aged care organisation. Sessions will be delivered one-on-one, scheduled once per week for 20-30 minutes (depending on each individual’s capacity).

An exercise program has been developed but will be modified as necessary depending on each individual’s capacity (i.e. less repetitions if fatigue occurs). An example of the exercises to be conducted with the mobility device include:
• Seated warm-up exercises, including 10 repetitions of shoulder rolls and holding chin to chest stretches for up to 20 seconds
• Seated leg-strength exercises, including 10 repetitions of leg raises, and 10 repetitions of heel raises
• Seated arm strength exercises, including 10 repetitions of bicep curls
• 10 repetitions of sit to stand exercises
• Standing balancing exercises, 10 repetitions of toe taps while holding onto the mobility device
Participants in the randomised group have access to the mobility device for approximately 10-30 minutes during their sessions with the health professional but will depend on each individual’s capacity. Participants will be monitored closely during the sessions. Compliance and use of the device will be recorded by staff using an exercise recording sheet.

After the first 6-week block, suitable exercise recommendations will be made for each participant, tailored to their own capacity. The exercise recommendations will be taken from exercises in the exercise program, examples of which may include:
• Seated warm-up exercises, including 10 repetitions of shoulder rolls and holding chin to chest stretches for up to 20 seconds
• Seated leg-strength exercises, including 10 repetitions of leg raises, and 10 repetitions of heel raises
• Seated arm strength exercises, including 10 repetitions of bicep curls
• 10 repetitions of sit to stand exercises
• Standing balancing exercises, 10 repetitions of toe taps while holding onto the mobility device

The participants will be encouraged to undertake these for the 6 weeks, for approximately 20-30 minutes every second day, during which time the intervention group will have access to the mobility device for up to an allocated 1 hour per day.

Use of the mobility device will be monitored and recorded by staff on an exercise recording sheet.
Exercise physiologists at the aged care facilities will complete assessments to measure mobility before and after the intervention.

Intervention code [1] 301291 0
Lifestyle
Intervention code [2] 301508 0
Treatment: Devices
Intervention code [3] 301509 0
Treatment: Other
Comparator / control treatment
The control group will receive the same mobility sessions with the health professional as the intervention group, delivered one-on-one, scheduled once per week for 20-30 minutes (depending on each individual’s capacity), using their prescribed walking aid.

An exercise program has been developed but will be modified as necessary depending on each individual’s capacity (i.e. less repetitions if fatigue occurs).

An example of the exercises to be conducted using their walking aid include:
• Seated warm-up exercises, including 10 repetitions of shoulder rolls and holding chin to chest stretches for up to 20 seconds
• Seated leg-strength exercises, including 10 repetitions of leg raises, and 10 repetitions of heel raises
• Seated arm strength exercises, including 10 repetitions of bicep curls
• 10 repetitions of sit to stand exercises
• Standing balancing exercises, 10 repetitions of toe taps while holding onto the mobility device

They will also receive a recommended program for the following 6-week recommendation period. They will not have access to the mobility device during the 12-week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 305985 0
Whether there is change in residents' mobility following use of the mobility device, measured by the Physical Mobility Scale.
Timepoint [1] 305985 0
Baseline; and 12 weeks after beginning of intervention
Secondary outcome [1] 347209 0
Whether there is change to physical function as assessed by Timed Up and Go and 2-minute walk.
Timepoint [1] 347209 0
Baseline; and 12 weeks after beginning of intervention
Secondary outcome [2] 348017 0
Whether there is change to habitual physical activity as assessed by accelerometer, measuring time spent sedentary.
Timepoint [2] 348017 0
Baseline; and 12 weeks after beginning of intervention
Secondary outcome [3] 348018 0
Whether there is change to quality of life as assessed by EQ-5D.
Timepoint [3] 348018 0
Baseline; and 12 weeks after beginning of intervention
Secondary outcome [4] 348653 0
Whether there is change to habitual physical activity as assessed by accelerometer, measuring time spent doing moderate activity
Timepoint [4] 348653 0
Baseline; and 12 weeks after beginning of intervention
Secondary outcome [5] 348654 0
Whether there is change to habitual physical activity as assessed by accelerometer, measuring time spent doing moderate/vigorous activity.
Timepoint [5] 348654 0
Baseline; and 12 weeks after beginning of intervention
Secondary outcome [6] 348655 0
Whether there is change to habitual physical activity as assessed by accelerometer, measuring time spent doing light activity.
Timepoint [6] 348655 0
Baseline; and 12 weeks after beginning of intervention
Secondary outcome [7] 348656 0
Whether there is change to habitual physical activity as assessed by accelerometer, measuring time spent sleeping.
Timepoint [7] 348656 0
Baseline; and 12 weeks after beginning of intervention

Eligibility
Key inclusion criteria
Residents of the aged care facility where the intervention is taking place, if they are able to weight bear, are stand assist, and can walk independently at least five metres
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents will be excluded from the research if they are physically or cognitively unable to participate, prescribed a wheelchair for mobility purposes, hoist-assisted lifters, non-weight bearing, or if they are deemed medically unfit to participate by the EP or physiotherapist at the aged care organisation who are able to mobilise confidently and independently will also be excluded from this research.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation in blocks of 4
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
2-factor mixed model rm ANOVA

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2018
Actual
29/06/2018
Date of last participant enrolment
Anticipated
27/07/2018
Actual
23/11/2018
Date of last data collection
Anticipated
26/10/2018
Actual
21/03/2019
Sample size
Target
48
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 299553 0
University
Name [1] 299553 0
University of South Australia
Country [1] 299553 0
Australia
Funding source category [2] 299560 0
Commercial sector/Industry
Name [2] 299560 0
Helping Hand Aged Care
Country [2] 299560 0
Australia
Primary sponsor type
University
Name
University of South Australia, City East Campus
Address
University of South Australia, City East Campus,
Postal Address: GPO Box 2471, CEA-14, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 298857 0
Commercial sector/Industry
Name [1] 298857 0
Helping Hand Aged Care
Address [1] 298857 0
c/o Head Office
49 Buxton Street, North Adelaide South Australia 5006
Country [1] 298857 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300450 0
University of South Australia, Human Research Ethics Committee
Ethics committee address [1] 300450 0
University of South Australia
Mawson Lakes Boulevard
Mawson Lakes SA 5095
Ethics committee country [1] 300450 0
Australia
Date submitted for ethics approval [1] 300450 0
Approval date [1] 300450 0
12/02/2018
Ethics approval number [1] 300450 0

Summary
Brief summary
The primary purpose of this study is to assess the effectiveness of a mobility device, commonly used for rehabilitation in America but not in Australia, for use by Australian adults with declining mobility living in aged care.
We hypothesise that this mobility device will have a positive impact on the physical wellbeing of residents living in aged care, relative to mobility training alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83702 0
A/Prof Gaynor Parfitt
Address 83702 0
University of South Australia
P7-08, Playford Building, City East Campus
Adelaide, South Australia, 5000
Country 83702 0
Australia
Phone 83702 0
+61 8 8302 1212
Fax 83702 0
Email 83702 0
gaynor.parfitt@unisa.edu.au
Contact person for public queries
Name 83703 0
A/Prof Gaynor Parfitt
Address 83703 0
University of South Australia
P7-08, Playford Building, City East Campus
Adelaide, South Australia, 5000
Country 83703 0
Australia
Phone 83703 0
+61 8 8302 1212
Fax 83703 0
Email 83703 0
gaynor.parfitt@unisa.edu.au
Contact person for scientific queries
Name 83704 0
A/Prof Gaynor Parfitt
Address 83704 0
University of South Australia
P7-08, Playford Building, City East Campus
Adelaide, South Australia, 5000
Country 83704 0
Australia
Phone 83704 0
+61 8 8302 1212
Fax 83704 0
Email 83704 0
gaynor.parfitt@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.