None listed
Conditions
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.
Interventions
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.
Sponsors
A/Prof Catherine Said
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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)
Outcome results
None listed