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Recumbent cycling to improve outcomes in people with hip fracture: a feasibility randomized trial
Said CM, Delahunt M, Hardidge A, Smith P, Tran P, McDonald L, Kefalianos E, Daniel C, Berney S
BMC Geriatrics 2021 Jun 29;21(394):Epub
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Early mobilization after surgery is a key recommendation for people with hip fracture, however this is achieved by only 50% of people. Recumbent bike riding has been used in other populations with limited mobility and has potential to allow early exercise in people post hip fracture. The primary aim of this pilot trial was to demonstrate the feasibility of a trial protocol designed to determine the effect of early post-operative cycling in bed on outcomes in people with hip fracture. METHODS: Single-blinded, multi-site randomized controlled pilot trial. Fifty-one people with hip fracture were recruited within 4 days of surgery from two sites in Victoria. Participants were randomly allocated to receive either usual care (n = 25) or usual care plus active cycling in bed (n = 26). The cycling intervention was delivered on weekdays until the participant could walk 15 m with assistance of one person. The primary outcomes were trial feasibility and safety. Clinical outcomes, including mobility (Modified Iowa Level of Assistance Scale) and delirium were measured at day seven post-operatively and at hospital discharge by an assessor blinded to group. Additional outcomes at discharge included gait speed, cognition and quality of life. RESULTS: The intervention was safe, feasible and acceptable to patients and staff. Delivery of the intervention was ceased on (median) day 9.5 (IQR 7 to 12); 73% of scheduled sessions were delivered; (median) 4 sessions (IQR 2.0 to 5.5) were delivered per participant with (median) 9 min 34 s (IQR 04:39, 17:34) of active cycling per session. The trial protocol was feasible, however at day seven 75% of participants had not met the criterion (able to walk 15 m with assistance of one person) to cease the cycling intervention. CONCLUSION: In bed cycling is feasible post-operatively following hip fracture, however seven days post-operatively is too early to evaluate the impact of the cycling intervention as many participants were still receiving the intervention. A fully powered RCT to explore the effectiveness and cost efficiency of this novel intervention is warranted. TRIAL REGISTRATION: The trial was prospectively registered (25/09/2017) with the Australian New Zealand Clinical Trials Registry ACTRN12617001345370.

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