Data

BikeNof Pilot Trial

The University of Melbourne

Dataset description

Fifty-one people with hip fracture were recruited within 4 days of surgery. Half were randomised to receive a recumbent bike riding protocol. Data were collected at three timepoints: Baseline (within 4 days of surgery), Day 7 Post-surgery and Hospital Discharge. Data collected included demographic data, clinical data (frailty, delirium, premorbid cognitive decline, fracture type, pre-morbid mobility). Current mobility status (primary outcome) was measured using the mILOA at Day 7 (n = 50) and Hospital Discharge (n = 48). Other outcomes collected at Hospital Discharge included gait speed (n = 34), cognition (MoCA; n = 31), EQ-5D-3L (n =39), Days to meet mobility milestone (walk 15 m two consecutive days) (n= 44), LoS (n=51). Data on usual care physiotherapy available for 51 participants (until day 7 post surgery, or until mobility milestone met); Data on cycling intervention available for n = 24 participants)
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Source Study

Trial acronym

BikeNoF

Trial ID

ACTRN12617001345370

Purpose

Treatment

Phase

Phase 2

Funding

Charities/Societies/Foundations,Austin Medical Research Foundation

Scientific enquiries

A/Prof Catherine Said

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. ....
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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).

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 ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    51

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Fracture Neck of Femur

Condition code    Injuries and Accidents , Musculoskeletal , Physical Medicine / Rehabilitation

Intervention

Intervention code Rehabilitation , Treatment: Devices

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 ....
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Comparison

Control group Active

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.

Outcomes

Outcome: 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: Participant discharge from hospital

Outcome: 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 ....
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Outcome: 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: End of trial

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

deidentified primary and secondary data

When will data be available?

01/01/2020

Available to whom?

researchers

Available for what types of analyses?

metaanalysis, secondary analyses

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au