BikeNof Pilot Trial

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 .... 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.
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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 .... 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 hospital discharge) from multiple sources including medical records, staff report and hospital incident reports (Riskman).
Timepoint: 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.
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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