Early intensive mobilization after acute high-risk abdominal surgery: a nonrandomized prospective feasibility trial =================================================================================================================== * Line Rokkedal Jønsson * Nicolai Bang Foss * Janne Orbæk * Morten Laksafoss Lauritsen * Helene Nygaard Sejrsen * Morten Tange Kristensen ## Abstract **Background:** Mobilization after emergency abdominal surgery is considered essential to facilitate rehabilitation and reduce postoperative complications. The aim of this study was to evaluate the feasibility of early intensive mobilization after acute high-risk abdominal (AHA) surgery. **Methods:** We conducted a nonrandomized, prospective feasibility trial of consecutive patients after AHA surgery at a university hospital in Denmark. The participants followed a predefined, interdisciplinary protocol for early intensive mobilization during the first 7 postoperative days (PODs) of their hospital admission. We evaluated feasibility in accordance with the percentage of patients who mobilized within 24 hours after surgery, mobilized at least 4 times per day and achieved daily goals of time out of bed and walking distance. **Results:** We included 48 patients with a mean age of 61 (standard deviation 17) years (48% female). Within 24 hours after surgery, 92% of the patients were mobilized and 82% or more were mobilized at least 4 times per day over the first 7 PODs. On PODs 1–3, 70%–89% of the participants achieved the daily goals of mobilization; participants still in hospital after POD 3 were less able to achieve the daily goals. Patient reported that the primary factors limiting their level of mobilization were fatigue, pain and dizziness. Participants not mobilized independently on POD 3 (28%) had significantly (*p* ≤ 0.04) fewer hours out of bed (4 v. 8 h), were less able to achieve the goals of time out of bed (45% v. 95%) and walking distance (62% v. 94%) and had longer hospital stays (14 v. 6 d) than participants mobilized independently on POD 3. **Conclusion:** The early intensive mobilization protocol seems feasible for most patients after AHA surgery. For nonindependent patients, however, alternative mobilization strategies and goals should be investigated. A cute high-risk abdominal (AHA) surgery (i.e., major emergency abdominal surgery for intestinal obstruction, perforated viscus or bowel ischemia) is associated with high risks of postoperative complication, death and prolonged hospital stay, compared with elective abdominal surgery.1–4 Enhanced recovery programs after AHA surgery have resulted in reduced mortality rates, fewer postoperative complications and shorter hospital stays.3–6 Such programs include reducing time before surgery, early administration of antibiotics, optimization of fluid therapy, early pain relief, oral nutrition and mobilization.4,7 Pulmonary complications — such as atelectasis, pneumonia and hypoxia — are prevalent after abdominal surgery and are associated with several negative factors, including delayed mobilization.1,7–13 Early and intensive mobilization after AHA surgery is therefore considered essential to reduce postoperative pulmonary complications and prevent loss of function.7,14,15 However, feasibility and strategies of early and intensive mobilization after emergency abdominal surgery needs further exploration.7,16,17 We sought to evaluate the feasibility of a predefined, interdisciplinary protocol for early intensive mobilization during the first postoperative week after AHA surgery. We also sought to describe physical performance, health-related quality of life and factors limiting mobilization during the first week and upon discharge after AHA surgery. ## Methods ### Design and setting We conducted a prospective, nonrandomized cohort study, designed as a feasibility trial to design potential future randomized controlled trials (RCTs). When planning and reporting this study, we followed the CONSORT 2010 statement, although we did not apply randomization.18 Our main outcomes were the acceptability and feasibility of early intensive mobilization for both patients undergoing AHA surgery and the health care staff. To evaluate feasibility, we used prespecified progression criteria focused on adherence to a mobilization protocol. Nonadherence could lead to modification or adjustment of the intervention for a future RCT.18,19 ### Participants We enrolled consecutive patients undergoing AHA surgery in the Department of Surgical Gastroenterology at the University Hospital of Hvidovre, Capital Region of Denmark, from September to December 2018. We screened all patients (aged ≥ 18 yr), undergoing major emergency gastrointestinal surgery, laparoscopy or laparotomy (including reoperation after elective gastrointestinal surgery). We excluded patients undergoing minor emergency gastrointestinal surgery (including appendectomy, cholecystectomy and simple herniotomy) or emergency gastrointestinal surgery without intervention (no abdominal pathology found), those not able to give informed consent to participate in the study within 48 hours after surgery or those without a Danish civil registration number (for legal reasons). We asked patients eligible for inclusion to participate immediately postoperatively and they gave written informed consent. ### Intervention The participants followed a standardized, optimized perioperative program, described previously.3,8 The intervention for early intensive mobilization was predefined in a mobilization protocol for each postoperative day (POD) during hospital admission in the first week after AHA surgery and included basic activities such as getting in and out of a bed, rising from a chair, standing and walking (Table 1). The health care staff in the department — including physiotherapists, occupational therapists and nursing staff — were responsible for motivating and assisting the participants to achieve the predefined goals in the mobilization protocol during PODs 1–7. The health care staff continuously sought to assist participants with obstacles for mobilization (e.g., guiding participants with regards to pain management and rest). A physiotherapist saw participants daily in the first postoperative week, including weekends, to assist and motivate them in early intensive mobilization. In the afternoons and evenings, the nursing staff were primarily responsible for mobilization of the participants. The health care staff continuously documented the extent of mobilization during PODs 1–7 in the data recording sheets. View this table: [Table 1](http://canjsurg.ca/content/66/3/E236/T1) Table 1 The mobilization protocol describing the daily goals of mobilization and the 4 prespecified progression criteria of feasibility during the first postoperative week following acute high-risk abdominal surgery Physiotherapists also instructed participants in relation to respiratory therapy, including deep breathing exercises every hour and coughing techniques. Participants with respiratory problems such as mucus, pneumonia or atelectasis also received positive expiratory pressure or continuous positive airway pressure, when needed. Participants who were unable to get out of bed received instructions on how to apply in-bed exercises, with the aim of maintaining a certain level of activity to avoid muscle atrophy and benefitting cardiovascular function. After the first postoperative week, patients who were still not able to mobilize independently continued training and rehabilitation with a physiotherapist or occupational therapist, but not daily. Participants undergoing reoperation during the first week after the initial AHA surgery restarted the mobilization protocol, including data collection. Participants undergoing reoperation after POD7 followed the early intensive mobilization protocol again, but we included only data after the first AHA surgery. ### Outcomes Our main outcome was the feasibility of early intensive mobilization according to 4 predefined progression criteria, as specified in Table 1. Health care staff evaluated patients’ preoperative health and physical status using the American Society of Anesthesiologists (ASA, 1–5 points) classification,20 the New Mobility Score (NMS, 0–9 points)21 and Barthel Index (BI, 0–100 points).22 The NMS evaluates self-reported walking ability before admission, including difficulties walking indoors, outdoors and during shopping. A score of 0 points indicates no walking ability at all and 9 points indicates no difficulties walking.21 The BI evaluates ability to perform activities of daily living.22 After surgery, health care staff evaluated basic mobility daily using the Cumulated Ambulation Score (CAS);23 ability to perform activities of daily living was again evaluated with the BI, and lower limb strength was evaluated with the 30-second chair stand test.24 The CAS evaluates postoperative independence in ambulation, including the 3 basic activities of getting in and out of a bed; getting up from sitting to standing, and back from standing to sitting in a chair with armrest; and indoor walking with an appropriate walking aid, if necessary. A physiotherapist rated each CAS activity on a 3-item scale (0–2 points). A total CAS of 6 points indicates participants can mobilize independently in all 3 activities, whereas a CAS of less than 6 points indicates participants need some level of assistance with ambulation.23 We evaluated 24-hour physical activity in the first postoperative week (time spent lying, sitting, standing and walking) using 2 accelerometers (SENS motion, SENS Innovation Aps).25 The first monitor was placed on the lateral distal side of the right thigh and the second monitor was attached to the chest, making it possible to differentiate between lying and sitting positions. The monitors were attached to the participants just after inclusion in the study and were removed at discharge or POD 8. We excluded data from the day of attachment and removal from the data analysis. We asked all participants, independent of their physical activity level, to indicate the main factor limiting their level of mobilization according to a predefined list, including pain, dizziness or nausea, fatigue or exhaustion, monitoring and surgical equipment (e.g., epidural, catheter, intravenous infusion, surgical drains) and other factors (e.g., cardiovascular or respiratory dysfunction, motor blockade after epidural). The health care staff selected factors limiting mobilization if participants were not able to express a reason themselves. A physician evaluated pulmonary complications (e.g., pneumonia, atelectasis, respiratory failure), scored according to the Clavien–Dindo classification.26 Scores higher than 1 point indicated pulmonary complications requiring treatment during hospital admission (e.g., pharmacological treatment, treatment with continuous positive airway pressure). Degree of pain and fatigue were evaluated using the Numeric Rating scale (0–10) and the Visual Analog Fatigue Scale (VAFS).27 For the VAFS, participants were asked to place a marker on a 10-cm vertical line, indicating the level of fatigue before mobilization, from not at all fatigued (0 points) to extremely fatigued (10 points). The participants’ health-related quality of life before surgery and at discharge was evaluated using the index visual analogue scale (0–100) in the EQ-5D questionnaire (EQ-5D-VAS).28 Falls during the first week after surgery were registered as adverse events when executing early intensive mobilization after AHA surgery. Only falls when mobilized with the health care staff were recorded. ### Statistical analysis In a feasibility study, formal sample size calculation is not required. We estimated that a sample size of about 50 patients undergoing AHA surgery was sufficient to explore the acceptability and practicalities of the intervention. We determined the feasibility of early and intensive mobilization using counts and percentages, corresponding to how many participants achieved the 4 prespecified progression criteria on PODs 1–7, based on data from the data recording sheets completed by the health care staff and data from the accelerometers during patients’ hospital stays. At time of this study, no clear guidance for developing percentage of progression criteria within feasibility studies was available.29 We therefore used other studies that included progression criteria as guidance for this study.18,30 We considered the intervention feasible if more than 80% of the participants achieved each of the 4 goals, and potentially feasible if 60%–80% achieved the goals with some small modifications to the intervention needed. If fewer than 60% of participants achieved the goals, we interpreted this to indicate the need for adjustment of the goals or the intervention. We determined acceptability of the intervention based on completion after enrolment, with a maximum expected drop-out rate of 20%. We tested descriptive data for normal distributions by visual inspection of the Q-Q plot. We presented continuous data as means and standard deviations (SDs), when normally distributed. Ordinal or non-normally distributed data are presented as medians and interquartile ranges (IQRs) and nominal data are presented as frequencies. We compared participants who were mobilized non-independently (CAS < 6) or independently (CAS = 6) using independent *t* tests to compare age and CST, and a Mann–Whitney test to compare length of stay after surgery. We used Fisher exact tests to compare NMS and postoperative pulmonary complications, and the Pearson χ2 test to compare ASA classification. Finally, we used simple logistic regression analysis to determine the predictive value of independent variables for not achieving mobilization targets to 1 or more of the 3 predefined progression criteria on POD 5 (mobilized ≥ 4 times per day, time out of bed, walking distance). We presented results from the logistic regression analysis as odds ratio (ORs) with 95% confidence interval (CIs). We considered a *p* value less than 0.05 as statistically significant. We stored study data online using Research Electronic Data Capture ([projectredcap.org](http://projectredcap.org)) and analyzed all data using IBM SPSS statistics for Windows (version 25). ### Ethics approval The study was approved by the capital regional committee on health research ethics of Denmark (H-18034444) and registered with the Danish Data Protection Agency (Ref: VD-2018–337) before recruitment. This study was also preregistered with [Clinicaltrials.gov](http://Clinicaltrials.gov) ([NCT03662932](http://canjsurg.ca/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03662932&atom=%2Fcjs%2F66%2F3%2FE236.atom)). ## Results A total of 65 patients underwent AHA surgery during the inclusion period, of whom 50 patients were eligible for participation and enrolled. The inclusion and exclusion process are illustrated in Figure 1, and the characteristics of the 50 included participants are presented in Table 2. Only 2 participants (4%) dropped out after inclusion. The 15 patients not included were comparable to those included, with a mean age of 59.2 (SD 20.9) years (47% female). ![Fig. 1](http://canjsurg.ca/https://www.canjsurg.ca/content/cjs/66/3/E236/F1.medium.gif) [Fig. 1](http://canjsurg.ca/content/66/3/E236/F1) Fig. 1 Flow diagram of study sample selection. AHA = acute high-risk abdominal surgery. View this table: [Table 2](http://canjsurg.ca/content/66/3/E236/T2) Table 2 Participant characteristics Four participants died during their hospital stays (1 on POD 7 and 3 after POD 8), but data from all 4 were included in the feasibility analyses. ### Feasibility of the intervention Within 24 hours after AHA surgery, 92% of the participants were mobilized to at least a sitting position and 82% or more of patients still in hospital were mobilized out of bed a minimum of 4 times per day during the first postoperative week (Table 3). Correspondingly, the goals for time out of bed and walking distance were achieved for at least 81% and 85% of the participants on PODs 1–3 and PODs 2–3, respectively, while participants still in hospital on PODs 4–7 were less able to achieve the goals. We evaluated predictors of not achieving mobilization targets among participants still in hospital on POD 5, on which the smallest number of participants (45%) achieved all 3 progression criteria (Table 4). Being nonindependent (CAS < 6), having a low preoperative health status (ASA 3–5 points) and having a high degree of pain and fatigue were significant predictors of not achieving mobilization targets on POD 5. Correspondingly, 10 of the 31 participants still in hospital on POD 5 had low preoperative health status (ASA 3–5 points) and 9 (90%) of these participants had more difficulties achieving the goals of mobilization on POD 5. View this table: [Table 3](http://canjsurg.ca/content/66/3/E236/T3) Table 3 Feasibility of the mobilization protocol after acute high-risk abdominal surgery based on 4 prespecified progression criteria View this table: [Table 4](http://canjsurg.ca/content/66/3/E236/T4) Table 4 Odds of not achieving mobilization targets in 1 or more of the 3 predefined progression criteria on postoperative day (POD) 5* Participants who were nonindependently mobilized (CAS < 6) had fewer hours out of bed and were less able to achieve the goals of time out of bed and walking distance on each POD compared with those who were independently mobilized (CAS = 6), as shown in Table 5. View this table: [Table 5](http://canjsurg.ca/content/66/3/E236/T5) Table 5 Difference between independently and nonindependently mobilized participants ### Postoperative outcomes Postoperative physical performance was low during the first days after AHA surgery (Table 6). The primary factors that limited mobilization on POD 1 were pain and dizziness or nausea; fatigue was the primary limiting factor from POD 2 onward (Figure 2). ![Fig. 2](http://canjsurg.ca/https://www.canjsurg.ca/content/cjs/66/3/E236/F2.medium.gif) [Fig. 2](http://canjsurg.ca/content/66/3/E236/F2) Fig. 2 Primary patient-reported factors limiting the level of mobilization in the first, third and seventh postoperative day (POD) after acute high-risk abdominal surgery. View this table: [Table 6](http://canjsurg.ca/content/66/3/E236/T6) Table 6 Postoperative physical performance, degree of pain and fatigue after acute high-risk abdominal surgery Participants who were nonindependently mobilized on POD 3 were significantly older (mean 71.3 [SD 11.9] yr v. 57.0 [SD 16.6] yr), more often needed assistance during walking before surgery (NMS < 9 points; *n* = 7 [54%] v. *n* = 2 [6%]), had lower preoperative health status (ASA > 2 points; *n* = 8 [62%] v. *n* = 5 [14%]), had lower postoperative physical function (mean no. of times standing up from chair (0.6 [SD 2.2] v. 6.6 [SD 4.7]) and had longer hospital stays after surgery (median 14 [IQR 11–22] d v. 6 [IQR 4–9] d) than independent participants (*p* ≤ 0.007). Ten participants (21%) developed a pulmonary complication after AHA surgery, including the 4 participants who died during the study period. Of the 13 participants who were nonindependently mobilized on POD 3, 6 (46%) developed pulmonary complications, compared with only 4 (11%) of the 35 participants who were independently mobilized (*p* = 0.016). During hospital admission, 14 participants had reoperations in the abdomen (7 during the first postoperative week), of whom 5 (36%) developed pulmonary complications, compared with 5 (15%) of the 34 participants who did not have reoperations (*p* = 0.103). On the EQ-5D-VAS, participants rated their health-related quality of life at a median of 75 (IQR 50–85) points before surgery, which reduced to 60 (50–74) points on discharge after surgery. No falls were recorded during hospital admission when mobilized with the health care staff. ## Discussion The present study shows that early intensive mobilization in the first postoperative week is feasible, safe and well tolerated by participants after AHA surgery. Although almost half of the participants depended on human assistance to mobilize on the first day after AHA surgery, and several participants had pain and dizziness that limited their ambulatory level, mobilization within 24 hours after AHA surgery was feasible. Thus, more than 80% of the participants were mobilized out of bed at least 4 times per day after POD 0. However, some participants, especially those mobilized nonindependently and those with low health status (ASA 3–5 points), had difficulties achieving the planned goals of time out of bed and walking distance. Significantly more nonindependently mobilized participants also developed postoperative pulmonary complications during hospital admission. This adds to the accumulated evidence that indicates that a low degree of physical activity during hospital admission is associated with pulmonary complications after surgery, underlining the importance of early intensive mobilization and patients reaching an independent ambulatory status as soon as possible after AHA surgery.8–13,31 In this study, advanced age and laparotomy (compared with laparoscopy) were not single predictors of compliance to the mobilization targets on POD 5, as expected. Instead, poor health status before surgery and nonindependent mobilization contributed to noncompliance with mobilization targets, indicating that overall physiologic reserves are a major determinant of degree of mobilization. The mobilization protocol used in this study prescribed more than 6 hours out of bed as a goal for mobilization on PODs 5–7, corresponding to study findings and guidelines for an elective enhanced recovery program in abdominal surgery.32–35 In the present study, fewer than 70% of participants still in hospital on POD 4 and PODs 5–7 managed to achieve the goal of 4 and 6 hours out of bed, respectively. At the same time, the average time out of bed for all participants still in hospital was more than 7 hours on these days, indicating a considerable heterogeneity in the physical performance of participants still in hospital after POD 3. At this late stage of the postoperative period, almost none of the participants who were nonindependently mobilized achieved the goal of time out of bed; indicating that the goal of 6 hours out of bed may be too optimistic for these patients, which is supported by previous studies involving patients after emergency abdominal surgery that reported higher risk of delayed mobilization, compared with elective surgery.9,34,36 Therefore, we suggest a different protocol for patients still in hospital after POD 3, by which those who are nonindependently mobilized have decreased goals of time out of bed and walking distance. The protocol does not need modification for independent patients in a possible future RCT. The reported barriers for patients not achieving mobilization goals were fatigue, pain and dizziness. Interdisciplinary interventions aiming to reduce postoperative barriers are therefore important and must include, for example, multimodal pain relief, nutrition, antiemetics, rest at night and fluid therapy to reduce pain, fatigue, dizziness, nausea and orthostatic intolerance.4,7 In particular, adaptation of pain regimes on the day of removal of epidural catheter — which was standardized on day 4 if the patient was not discharged earlier — seems important to avoid rebound pain, as a barrier to mobilization.37 Other studies have also reported that patients felt restricted by surgical drains, tubes, oxygen lines and continuous monitoring of vital signs during hospital admission.8,10,36,38–40 To reduce these restrictions, easy access to appropriate walking devices (e.g., the high walking frame with wheels) may facilitate independent mobilization owing to decreased pain when mobilized this way and less insecurity secondary to symptoms of fatigue or dizziness. Furthermore, the walking devices are suitable for transporting all the surgical equipment (e.g., epidural, catheter, intravenous infusion, surgical drains, parental nutrition). Participants not remembering how much they had been out of bed, their lack of motivation toward physical activity and their diminished health-related quality of life after AHA surgery may have also influenced the feasibility of mobilization during hospital admission in the present study.38–41 Evidence suggests that using activity monitors so that participants can monitor their level of physical activity from minute to minute can increase time out of bed and physical activity.42,43 Such monitors, therefore, may be added to the mobilization program, especially for independent patients, being relevant for motivation and visual feedback on the amount of mobilization in daily practice during hospital admission, after discharge or in an RCT. To explore the status of health-related quality of life in patients undergoing AHA surgery, we used EQ-5D-VAS. As anticipated, participant quality of life was reduced at time of discharge, compared with before undergoing AHA surgery (median 60 v. 75 points). In comparison, the mean EQ-5D-VAS scores in a healthy Danish population was 82.4 points (95% CI 81.5–83.4 points),44 showing that patients undergoing AHA surgery may have diminished quality of life compared with a healthy population and that they experience reduced health-related quality of life at the time of discharge, in addition to reduced functional capacity. Accordingly, self-reported quality of life is an important follow-up outcome when evaluating the effects of interventions after AHA surgery in future studies. ### Limitations All participants were seen by a physiotherapist daily in the first postoperative week, including weekends, to assist and motivate to early intensive mobilization, while the nursing staff were primarily responsible for mobilization of the participants in the afternoons and evenings. However, because of missing data on walking distance in the recordings sheet, we are uncertain if the nursing staff mobilized the participants less than anticipated. The nursing staff hold a key position in supporting mobilization, as they spend so much time with the patients, but several studies have reported that heavy workload, attitudes about mobilization and limited availability of health care staff can be a barrier for mobilization.17,38,39,41 Overall, heavy workload or missing registration of walking distance in the evening shift may have affected the result of feasibility of the goals of time out of bed or walking distance. This highlights the importance of identifying all barriers when tailoring the implementation of early intensive mobilization to each context and patient abilities.39 Prioritizing and allocating physiotherapist resources in both the daytime and evenings could be an important strategy to ensure early and intensive mobilization after AHA surgery in the hospital ward, both in an RCT and in real-world clinical practice. Falls are considered an adverse event when executing early and intensive mobilization, but only falls during mobilization with the health care staff were recorded systematically in the present study. However, we are aware of only 1 participant during the entire study period reporting a fall when unsupervised. ## Conclusion The early intensive mobilization protocol was well tolerated by patients undergoing AHA surgery, despite patients having significantly decreased physical function after their surgery. Patients who were nonindependently mobilized had difficulties achieving the goals of time out of bed and walking distance; interventions to reduce factors limiting mobilization for patients with a low ambulatory status are needed. ## Acknowledgements The authors would like to thank the physiotherapist and occupational therapist from the department of Physiotherapy and Occupational Therapy and the nursing staff from the Gastro Unit Surgical Division, Hvidovre Hospital in Denmark for the contribution to collecting data and performing the intervention. They particularly thank Trine Rehfeld Lind, Line Feldvoss Karlsson and Ian Nicolai Mitchell. ## Footnotes * Presented in part at Hvidovre Hospital Researcher’s Day (April 2019, Hvidovre, Denmark), The Symposium for Physiotherapist and Occupational Therapist in the Capital Region of Denmark (October 2019, Herlev Hospital, Denmark), The World Physiotherapy Congress 2021 (April 2021, online), The Congress of the Danish Physical Therapy Association (March 2022, Odense, Denmark). * **Competing interests:** None declared. * **Contributors:** All of the authors contributed to the conception and design of the work, and the acquisition, analysis and interpretation of data. All of the authors drafted the manuscript, revised it critically for important intellectual content, gave final approval of the version to be published and agreed to be accountable for all aspects of the work. * **Funding:** This work was supported by the Hvidovre University Hospital research pool in 2017 (E-21200-04). * Accepted January 22, 2023. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY-NC-ND 4.0) licence, which permits use, distribution and reproduction in any medium, provided that the original publication is properly cited, the use is noncommercial (i.e., research or educational use), and no modifications or adaptations are made. See: [https://creativecommons.org/licenses/by-nc-nd/4.0/](https://creativecommons.org/licenses/by-nc-nd/4.0/) ## References 1. Tengberg LT, Cihoric M, Foss NB, et al. 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