Pre- and Postoperative Exercise Effectiveness in Mobility, Hemostatic Balance, and Prognostic Biomarkers in Hip Fracture Patients: A Study Protocol for a Randomized Controlled Trial

Abstract

Hip fractures are a major health concern, particularly for older adults, as they can reduce life quality, mobility loss, and even death. Current evidence reveals that early intervention is recommended for endurance in patients with hip fractures. To our knowledge, preoperative exercise intervention in patients with hip fractures remains poorly researched, and no study has yet applied aerobic exercise preoperatively. This study aims to investigate the short-term benefits of a supervised preoperative aerobic moderate-intensity interval training (MIIT) program and the added effect of an 8-week postoperative MIIT aerobic exercise program with a portable upper extremity cycle ergometer. The work-to-recovery ratio will be 1-to-1, consisting of 120 s for each bout and four and eight rounds for the pre- and postoperative programs, respectively. The preoperative program will be delivered twice a day. A parallel group, single-blinded, randomized controlled trial (RCT) was planned to be conducted with 58 patients each in the intervention and control groups. This study has two primary purposes. First, to study the effect of a preoperative aerobic exercise program with a portable upper extremity cycle ergometer on immediate postoperative mobility. Second, to investigate the additional effect of an 8-week postoperative aerobic exercise program with a portable upper extremity cycle ergometer on the walking distance at eight weeks after surgery. This study also has several secondary objectives, such as ameliorating surgical and keeping hemostatic balance throughout exercise. This study may expand our knowledge of preoperative exercise effectiveness in hip fracture patients and enhance the current literature about early intervention benefits.

Keywords: coagulation; exercise therapy; fibrinolysis; hip fracture; physiotherapy; prehabilitation; rehabilitation; rotational thromboelastometry.

Figure 1

Graphical illustration of the study design. In the frame “outcomes”, only the first integration of the assessments and not the follow-up assessment can be seen. For example, mHHS will be assessed not only at admission (first integration as shown in the box) but also at 4, 8, 26 and 52 weeks (follow-up assessment). Accordingly, the evaluation of the basic mobility through the CAS scale will be evaluated on the first; second and third postoperative day and at 4, 8, 26 and 52 weeks postoperatively. Blood samples will be collected on the day of admission; one day before surgery; on the third postoperative day and at 1, 4, 8, 26 and 52 weeks postoperatively. Analysis of the coagulation biomarkers will be done by ROTEM. After the 8 weeks of postoperative intervention, there will be no intervention for any of the two groups. The time from admission to surgery will vary. Created with BioRender.com (accessed on 16 April 2023). Abbreviations: MIIT = Moderate Intensity Interval Training; CAS = Cumulative Ambulation Score; 6MWT = six-minute walk test; TUG = Timed-Up and Go; mHHS = modified Harris Hip Score; LEFS = Lower Extremity Functional Scale; NMS = New Mobility Score; La = Lactate concentration of capillary blood; ROTEM = rotational thromboelastometry; Hemostatic profile = tissue Plasminogen Activator (tPA); Plasminogen Activator Inhibitor-1 (PAI-1); Endogenous Thrombin Potential (ETP); Fibrinogen; D-dimers; von Willebrand factor antigen; von Willebrand factor activity; Thrombin–Antithrombin Complex (TAT); Thrombomodulin; platelet function—PFA-100; hemostatic profile using viscoelastic techniques—ROTEM; pre-op = preoperative; peri-op = perioperative; post-op = postoperative.