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Trial registered on ANZCTR


Registration number
ACTRN12617001345370
Ethics application status
Approved
Date submitted
1/09/2017
Date registered
25/09/2017
Date last updated
14/01/2021
Date data sharing statement initially provided
18/01/2019
Date results information initially provided
14/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Recumbent bike riding for people with fractured neck of femur: A feasibility trial
Scientific title
Recumbent bike riding for people with fractured neck of femur: A feasibility trial
Secondary ID [1] 292788 0
Nil
Universal Trial Number (UTN)
U1111-1201-5610
Trial acronym
BikeNoF
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Fracture Neck of Femur 304597 0
Condition category
Condition code
Injuries and Accidents 303923 303923 0 0
Fractures
Physical Medicine / Rehabilitation 303924 303924 0 0
Physiotherapy
Musculoskeletal 304023 304023 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group. The intervention group will receive routine care which includes nursing, medical and physiotherapy care. Care will initially be provided in the acute hospital, but some participants will require additional care in a rehabilitation ward. Participants in the both the intervention and usual care arms will receive standard physiotherapy care, according to the Australian and New Zealand Guideline for Hip Fracture Care.
The intervention will commence once consent has been obtained and the baseline assessment has been conducted; which will occur within 48 hours of surgery. In addition to usual care, participants in the intervention arm will actively cycle (with a passive back up rate of 5 cycles per minute) on a recumbent bike (Motomed Letto 2). The bike training sessions will be undertaken once a day on weekdays for up to 60 minutes per session. The session length will be determined by the treating therapist, based on the exercise tolerance of the individual participant. (As this is a feasibility trial, actual session length will be monitored to inform optimal session length in future trials) They will be delivered to participants in their bed. Sessions will be supervised by a physiotherapy research assistant. Participants will be encouraged to work up to a moderate intensity as measured by the BORG rating perceived exertion scale (12-15), within the limits of their medical condition. Participants will continue to receive the bike training intervention until they meet the mobility criterion of ability to walk a minimum of 15 metres with assistance of one person for two consecutive days, as assessed by the usual care physiotherapist. The intervention will also be ceased if the treating team decide that there are no further rehabilitation goals. If the participant is transferred to rehabilitation within Austin Health, the intervention will continue until the mobility milestone is met. Data on exercise time and intensity and any barriers to training will be recorded by the intervention therapist as indicators of adherence. Pain will also be assessed using a written numerical rating scale at the end of the session. The intervention will not be delivered if a participant’s International Normalised Ratio (INR) is >3, to minimise risk of post operative bleeding. The intervention will recommence once INR is below 3. Data on INR is collected as part of routine post operative care, with the frequency of testing determined by the treating medical team based on factors including medical history and medications. No additional blood tests are required specifically for this study.
Intervention code [1] 299030 0
Rehabilitation
Intervention code [2] 299031 0
Treatment: Devices
Comparator / control treatment
The control group will receive routine care which includes nursing, medical and physiotherapy care. Care will initially be provided in the acute hospital, but some participants will require additional care in a rehabilitation ward. Participants in the both the intervention and usual care arms will receive standard physiotherapy care, according to the current Austin Health Fractured Neck of Femur: Physiotherapy Clinical Guideline.
Control group
Active

Outcomes
Primary outcome [1] 303259 0
intervention feasibility : number of bike training sessions delivered, reasons for non - delivery of sessions, length of training sessions and feedback from patients on the acceptability of the intervention.
Timepoint [1] 303259 0
Participant discharge from hospital
Primary outcome [2] 303260 0
intervention safety; number of adverse events throughout the trial, including mortality, post-operative complications, issues with surgical fixation, bleeding, delirium (as measured daily using the Confusion Assessment Method [CAM]), infections, falls and pressure areas. This information will be collected by usual care physiotherapy staff as they occur. In addition, the blinded assessor will verify adverse events at each assessment time point (7 days post surgery and hospital discharge) from multiple sources including medical records, staff report and hospital incident reports (Riskman).
Timepoint [2] 303260 0
Usual care physiotherapy staff will assess the CAM on a daily basis. The presence of other adverse events will be documented by usual care staff as they occur (i.e. daily until discharge).

Blinded assessors will verify adverse events at 7 days post surgery and hospital discharge.
Primary outcome [3] 303272 0
trial feasibility; participant recruitment and retention, completion of outcome measures, documentation of any trial protocol deviations or variations, and feedback from trial staff about any issues encountered in the delivery of the protocol.
Timepoint [3] 303272 0
End of trial
Secondary outcome [1] 338456 0
Modified Iowa Level of Assistance Scale
Timepoint [1] 338456 0
7 days post surgery
Secondary outcome [2] 338457 0
Modified Iowa Level of Assistance Scale
Timepoint [2] 338457 0
hospital discharge
Secondary outcome [3] 338458 0
Discharge destination as documented in the medical record.
Timepoint [3] 338458 0
Hospital discharge
Secondary outcome [4] 338459 0
gait speed, measured using the 6 m timed walk test
Timepoint [4] 338459 0
hospital discharge
Secondary outcome [5] 338460 0
Acute length of stay, defined as days between acute hospital admission and acute hospital discharge, as determined from the medical record.
Timepoint [5] 338460 0
acute hospital discharge
Secondary outcome [6] 338461 0
Quality of life, measured using the Euro-quol 5 D (EQ5D) and EuroQol Visual analogue scale
Timepoint [6] 338461 0
Hospital discharge
Secondary outcome [7] 338734 0
Subacute length of stay; defined as days between subacute hospital admission and subacute hospital discharge, as determined from the medical record.
Timepoint [7] 338734 0
Subacute hospital discharge

Eligibility
Key inclusion criteria
• Have had surgical correction of a fracture neck of femur,
• Be unable to walk 15 m with assistance at enrolment (within 4 days of surgery).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Fracture is pathological or result of a high velocity trauma (eg car accident),
• Other lower limb fractures present,
• Any medical conditions present which would prevent either mobilisation/ recumbent bike riding (including lower limb NWB status),
• They were unable to walk > 15 m premorbidly,
• They are pregnant
• They are not expected to survive > 7 days, as determined by the treating physician.
• Anticipated discharge from study hospital < 7 days (including transfer to another hospital or health service, or transfer to a hospital within a participating health service that is unable to provide the intervention due to lack of equipment).
• Weight over 135 kg (weight limit of equipment)

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)
Allocation will be concealed by opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be blocked and stratified for pre-exisiting dementia, as identifed using the Informant Questionnaire of Cognitive Decline in the Elderly (Short Form), and site. Randomisation will be computer generated and performed by a third party.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis
This is a pilot trial to demonstrate the feasibility of the proposed protocol, thus formal sample size estimation has not been completed. Based on our experience with other trials, a sample of 50 participants (with 25 in each arm) will provide sufficient data for us to test the protocol in a robust manner and provide sufficient data for sample size analysis for the definitive trial.

To determine whether the intervention is feasible, the proportion of scheduled sessions delivered and median length of session time will be calculated and reasons for non-delivery of sessions inspected by the investigators. Patient feedback will be examined thematically using a grounded theory approach.

To determine whether the trial protocol is feasible, data on key project quality indicators will be collated, including data on participant recruitment, participant retention, completed outcome data at each time point. Trial protocol deviations or variations and trial staff feedback will be reviewed by investigators.

To determine whether the intervention is safe, adverse events will be compared between groups using appropriate statistical techniques.

Baseline characteristics will be examined for the intervention and control groups, to determine whether the groups are similar.

Data from the mILOA will be will be examined for normality, and descriptive data calculated for the intervention and control groups using either parametric or nonparametric statistics as appropriate. Effect size will be calculated and sample size will be estimated for the larger study, with the assistance of a statistician. Note that as this study will not be sufficiently powered, tests for significance will not be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8940 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 12052 0
Footscray Hospital - Footscray
Recruitment hospital [3] 12053 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 17311 0
3084 - Heidelberg
Recruitment postcode(s) [2] 24209 0
3011 - Footscray
Recruitment postcode(s) [3] 24210 0
3016 - Williamstown

Funding & Sponsors
Funding source category [1] 297420 0
Charities/Societies/Foundations
Name [1] 297420 0
Austin Medical Research Foundation
Address [1] 297420 0
Studley Rd
Heidelberg, 3084 Victoria
Country [1] 297420 0
Australia
Funding source category [2] 300826 0
University
Name [2] 300826 0
The University of Melbourne: Melbourne School of Health Sciences
Address [2] 300826 0
Melbourne School of Health Sciences, Grattan St, Parkville, 3010 Victoria
Country [2] 300826 0
Australia
Primary sponsor type
Individual
Name
A/Prof Catherine Said
Address
Physiotherapy Dept
Austin Health
Studley Rd
Heidelberg, 3084 Victoria
Country
Australia
Secondary sponsor category [1] 296413 0
None
Name [1] 296413 0
Address [1] 296413 0
Country [1] 296413 0
Other collaborator category [1] 279703 0
Individual
Name [1] 279703 0
Ms Marisa Delahunt
Address [1] 279703 0
Austin Health
Studley Rd
Heidelberg, 3084, Vic
Country [1] 279703 0
Australia
Other collaborator category [2] 279704 0
Individual
Name [2] 279704 0
A/Prof Sue Berney
Address [2] 279704 0
Austin Health
Studley Rd
Heidelberg, 3084, Vic
Country [2] 279704 0
Australia
Other collaborator category [3] 279705 0
Individual
Name [3] 279705 0
Mr Andrew Hardidge
Address [3] 279705 0
Austin Health
Studley Rd
Heidelberg, 3084, Vic
Country [3] 279705 0
Australia
Other collaborator category [4] 280375 0
Individual
Name [4] 280375 0
Cathy Daniel
Address [4] 280375 0
Nursing
Alan Gilbert Building
Grattan St
University of Melbourne
Parkville, 3010 Victoria
Country [4] 280375 0
Australia
Other collaborator category [5] 280376 0
Individual
Name [5] 280376 0
Phong Tran
Address [5] 280376 0
Footscray Hospital
160 Gordon St
Footscray Victoria. 3011
Country [5] 280376 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298526 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 298526 0
145 Studley Rd
Heidelberg, 3084
Victoria
Ethics committee country [1] 298526 0
Australia
Date submitted for ethics approval [1] 298526 0
30/05/2017
Approval date [1] 298526 0
27/06/2017
Ethics approval number [1] 298526 0
HREC/17/Austin/274

Summary
Brief summary
Early mobilisation post operatively is a key recommendation for people with fractured neck of femur (NOF). Exercise and early mobilisation may reduce complications post operatively, including delirium, and may lead to shorter length of stay and better outcomes. However, evidence indicates that as few as 50 % of people are able to be mobilised by day 2 post operatively. Barriers to mobilisation include confusion and drowsiness, low blood pressure or an unacceptable level of manual handling risk. Other methods of safely exercising people with fractured NOF who are unable to safely mobilise should be explored.

Recumbent bike riding has been used for exercise in other bed bound populations including spinal cord injury and patients from an intensive care unit. Evidence has shown this treatment is feasible and safe in these populations. There is preliminary evidence that recumbent bike riding is associated with reduced incidence of delirium and reduced muscle wasting in people from Intensive Care Units (ICU). Recumbent bike riding has potential to allow early exercise in people with a fractured NOF, however to date this intervention has not been used in this population. Thus the purpose of this study is to demonstrate the feasibility of a trial of recumbent bike riding in people unable to mobilise post fracture NOF. A secondary aim is to obtain preliminary data on the impact of recumbent bike riding on mobility, delirium and length of stay.

Fifty people who have received surgical management for a fractured NOF will be recruited within 48 hours of surgery. They will be randomly allocated to receive either usual care or usual care plus up to an hour active recumbent bike cycling. They will continue to receive the intervention until they can walk 15m with assistance of one person for two consecutive day. Primary outcomes include data demonstrating the feasibility of delivering the intervention and conducting the proposed RCT. The primary clinical outcome is mobility seven days post operatively, as measured using the Modified Iowa Level of Assistance Scale. (mILOA) Secondary clinical outcomes include mobility at discharge (measured using the mILOA and gait speed), discharge destination, length of stay and quality of life.

Data from this study will inform the design of a larger RCT which will form the basis of applications to NHMRC and other funding bodies.
Trial website
N/A
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 77358 0
A/Prof Catherine Said
Address 77358 0
Physiotherapy Department
Austin Health
Studley Rd
Heidelberg, 3084
Victoria
Country 77358 0
Australia
Phone 77358 0
+61 3 9496 3697
Fax 77358 0
Email 77358 0
cathy.said@austin.org.au
Contact person for public queries
Name 77359 0
A/Prof Catherine Said
Address 77359 0
Physiotherapy Department
Austin Health
Studley Rd
Heidelberg, 3084
Victoria
Country 77359 0
Australia
Phone 77359 0
+61 3 9496 3697
Fax 77359 0
Email 77359 0
cathy.said@austin.org.au
Contact person for scientific queries
Name 77360 0
A/Prof Catherine Said
Address 77360 0
Physiotherapy Department
Austin Health
Studley Rd
Heidelberg, 3084
Victoria
Country 77360 0
Australia
Phone 77360 0
+61 3 9496 3697
Fax 77360 0
Email 77360 0
cathy.said@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
deidentified primary and secondary data
When will data be available (start and end dates)?
01/01/2020
Available to whom?
researchers
Available for what types of analyses?
metaanalysis, secondary analyses
How or where can data be obtained?
contact researchers.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 816 0
Study protocol
Citation [1] 816 0
Link [1] 816 0
Email [1] 816 0
Other [1] 816 0
available via contact with researchers
Attachment [1] 816 0
Type [2] 1106 0
Informed consent form
Citation [2] 1106 0
Link [2] 1106 0
Email [2] 1106 0
Other [2] 1106 0
available via contact with researchers
Attachment [2] 1106 0
Type [3] 1107 0
Ethical approval
Citation [3] 1107 0
Link [3] 1107 0
Email [3] 1107 0
Other [3] 1107 0
available via contact with researchers
Attachment [3] 1107 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary