Physiotherapy - Research Publications
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ItemPrehabilitation in high-risk patients scheduled for major abdominal cancer surgery: a feasibility study(BMC, 2022-08-23)BACKGROUND: Patients presenting for major surgery with low cardiorespiratory fitness (deconditioning) and other modifiable risk factors are at increased risk of postoperative complications. This study investigated the feasibility of delivering prehabilitation in high-risk patients scheduled for major abdominal cancer surgery. METHODS: Eligible patients in this single-center cohort study included patients with poor fitness (objectively assessed by cardiopulmonary exercise testing, CPET) scheduled for elective major abdominal cancer surgery. Patients were recruited to participate in a prehabilitation program that spanned up to 6 weeks pre-operatively and comprised aerobic and resistance exercise training, breathing exercise, and nutritional support. The primary outcome assessed pre-specified feasibility targets: recruitment >70%, retention >85%, and intervention adherence >70%. Secondary outcomes were assessed for improved pre-operative functional status and health-related quality of life and for postoperative complications. RESULTS: Eighty-two (34%) out of 238 patients screened between April 2018 and December 2019 were eligible for recruitment. Fifty (61%) patients (52% males) with a median age of 71 (IQR, 63-77) years participated in the study. Baseline oxygen consumption the at anaerobic threshold and at peak exercise (mean±SD: 9.8±1.8 and 14.0±2.9 mL/kg/min, respectively) confirmed the deconditioned state of the study cohort. The retention rate within the prehabilitation program was 84%, with 42 participants returning for repeat CPET testing. While >60% of participants preferred to do home-based prehabilitation, adherence to the intervention was low-with only 12 (28%) and 15 (35%) of patients having self-reported compliance >70% with their exercise prescriptions. CONCLUSION: Our prehabilitation program in high-risk cancer surgery patients did not achieve pre-specified targets for recruitment, retention, and self-reported program adherence. These findings underpin the importance of implementation research and strategies for the prehabilitation programs in major surgery. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12620000073909 ) retrospectively registered.
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ItemCore outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)(BMC, 2022-08-06)BACKGROUND: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify and develop a set of core outcome domains and associated measurement instruments to include in all research in critically ill patients. METHODS: An updated systematic review informed a two-stage modified Delphi consensus process (domains followed by instruments). Measurement instruments for domains considered 'essential' were taken through the second stage of the Delphi and a subsequent consensus meeting. RESULTS: In total, 213 participants (41 patients/caregivers, 50 clinical researchers and 122 healthcare professionals) from 24 countries contributed. Consensus was reached on time points (30 and 90 days post-randomisation). Three domains were considered 'essential' at 30 days (survival, physical function and Infection) and five at 90 days (survival, physical function, activities of daily living, nutritional status and muscle/nerve function). Core 'essential' measurement instruments reached consensus for survival and activities of daily living, and 'recommended' measurement instruments for physical function, nutritional status and muscle/nerve function. No consensus was reached for a measurement instrument for Infection. Four further domains met criteria for 'recommended,' but not 'essential,' to measure at 30 days post-randomisation (organ dysfunction, muscle/nerve function, nutritional status and wound healing) and three at 90 days (frailty, body composition and organ dysfunction). CONCLUSION: The CONCISE core outcome set is an internationally agreed minimum set of outcomes for use at 30 and 90 days post-randomisation, in nutritional and metabolic clinical research in critically ill adults.
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ItemThe sit-to-stand test as a patient-centered functional outcome for critical care research: a pooled analysis of five international rehabilitation studies(BMC, 2022-06-13)BACKGROUND: With ICU mortality rates decreasing, it is increasingly important to identify interventions to minimize functional impairments and improve outcomes for survivors. Simultaneously, we must identify robust patient-centered functional outcomes for our trials. Our objective was to investigate the clinimetric properties of a progression of three outcome measures, from strength to function. METHODS: Adults (≥ 18 years) enrolled in five international ICU rehabilitation studies. Participants required ICU admission were mechanically ventilated and previously independent. Outcomes included two components of the Physical Function in ICU Test-scored (PFIT-s): knee extensor strength and assistance required to move from sit to stand (STS); the 30-s STS (30 s STS) test was the third outcome. We analyzed survivors at ICU and hospital discharge. We report participant demographics, baseline characteristics, and outcome data using descriptive statistics. Floor effects represented ≥ 15% of participants with minimum score and ceiling effects ≥ 15% with maximum score. We calculated the overall group difference score (hospital discharge score minus ICU discharge) for participants with paired assessments. RESULTS: Of 451 participants, most were male (n = 278, 61.6%) with a median age between 60 and 66 years, a mean APACHE II score between 19 and 24, a median duration of mechanical ventilation between 4 and 8 days, ICU length of stay (LOS) between 7 and 11 days, and hospital LOS between 22 and 31 days. For knee extension, we observed a ceiling effect in 48.5% (160/330) of participants at ICU discharge and in 74.7% (115/154) at hospital discharge; the median [1st, 3rd quartile] PFIT-s difference score (n = 139) was 0 [0,1] (p < 0.05). For STS assistance, we observed a ceiling effect in 45.9% (150/327) at ICU discharge and in 77.5% (79/102) at hospital discharge; the median PFIT-s difference score (n = 87) was 1 [0, 2] (p < 0.05). For 30 s STS, we observed a floor effect in 15.0% (12/80) at ICU discharge but did not observe a floor or ceiling effect at hospital discharge. The median 30 s STS difference score (n = 54) was 3 [1, 6] (p < 0.05). CONCLUSION: Among three progressive outcome measures evaluated in this study, the 30 s STS test appears to have the most favorable clinimetric properties to assess function at ICU and hospital discharge in moderate to severely ill participants.
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ItemPatient and clinician perspectives of pelvic floor dysfunction after gynaecological cancer(ELSEVIER SCIENCE INC, 2022-05-27)PURPOSE: To explore and compare patient and clinician experiences, knowledge and preferences in relation to screening and management of pelvic floor (PF) dysfunction in the gynaecology-oncology setting. METHODS: Semi-structured interviews were conducted with women reporting PF symptoms after gynaecological cancer treatment, and gynaecology-oncology clinicians. Interviews were transcribed and thematically analysed and were conducted until data saturation was reached. RESULTS: We interviewed 12 patients and 13 clinicians. We identified two main themes: (1) Experience with PF symptoms, screening, disclosure and management and (2) Future hope of what should happen to screen and manage PF symptoms. Differences between what participants had experienced and what they felt should happen highlighted a perceived need for improving PF screening and management. A sub-theme that reflected relevant barriers and enablers was also identified. Barriers included time pressure, being focussed on cancer treatment and not side-effects, and patients feeling unwell, emotional, and overwhelmed with the logistics of oncology appointments. Enablers included the patient-clinician relationship, and opportunities for improving management included integrating nursing and PF physiotherapy with oncology appointments. CONCLUSIONS: Gynaecological cancer survivors and clinicians perceive a need to improve screening and management for PF symptoms. While barriers and differences in perception exist, there are opportunities to improve how PF symptoms can be screened and managed in this population. Further studies exploring the feasibility of providing integrated multidisciplinary PF therapy services may be warranted.
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ItemExercise in allogeneic bone marrow transplantation: a qualitative representation of the patient perspective(SPRINGER, 2022-03-16)PURPOSE: Exercise is emerging as a vital aspect of care to alleviate the physical and psychosocial symptom burden associated with allogeneic bone marrow transplantation (BMT). Understanding the patient perspective regarding exercise is important to move towards implementation. This study aimed to characterise experiences and views regarding participation in an exercise program in adults receiving treatment for haematological disease with allogeneic BMT. METHODS: Individual semi-structured interviews were conducted with 35 participants from either an early- or late-commencing supervised group-based exercise program. Using an inductive, conventional approach to qualitative content analysis data were independently analysed by two researchers. RESULTS: Six major themes and 33 sub-themes were identified: this encompassed motivation, physical opportunity and capability to exercise; psychosocial effects of group-based exercise; experienced impact of participation in an exercise program; and intervention design considerations. Key barriers to exercise included symptom severity and fluctuating health and distance or difficult access to an exercise facility or equipment, whilst facilitators included encouragement from staff; peer support in the group-based setting; flexibility; education; and ability to measure change. CONCLUSION: This study highlights the importance of a flexible approach to exercise with consideration of individual symptoms and preferences. The perceived psychological impact of exercise should not be underestimated; future exercise programs should be designed in partnership with patients, with consideration of group-based activities to reduce social isolation if this is feasible in the treatment context. Intervention design should also acknowledge the individual's physical and psychological capability, opportunity and automatic and reflective motivation to direct and sustain exercise behaviours following BMT.
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ItemImproving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial(BMJ PUBLISHING GROUP, 2022-04-01)INTRODUCTION: Physical rehabilitation delivered early following admission to the intensive care unit (ICU) has the potential to improve short-term and long-term outcomes. The use of supine cycling together with other rehabilitation techniques has potential as a method of introducing rehabilitation earlier in the patient journey. The aim of the study is to determine the feasibility of delivering the designed protocol of a randomised clinical trial comparing a protocolised early rehabilitation programme including cycling with usual care. This feasibility study will inform a larger multicentre study. METHODS AND ANALYSIS: 90 acute care medical patients from two mixed medical-surgical ICUs will be recruited. We will include ventilated patients within 72 hours of initiation of mechanical ventilation and expected to be ventilated a further 48 hours or more. Patients will receive usual care or usual care plus two 30 min rehabilitation sessions 5 days/week.Feasibility outcomes are (1) recruitment of one to two patients per month per site; (2) protocol fidelity with >75% of patients commencing interventions within 72 hours of mechanical ventilation, with >70% interventions delivered; and (3) blinded outcome measures recorded at three time points in >80% of patients. Secondary outcomes are (1) strength and function, the Physical Function ICU Test-scored measured on ICU discharge; (2) hospital length of stay; and (3) mental health and physical ability at 3 months using the WHO Disability Assessment Schedule 2. An economic analysis using hospital health services data reported with an embedded health economic study will collect and assess economic and quality of life data including the Hospital Anxiety and Depression Scales core, the Euroqol-5 Dimension-5 Level and the Impact of Event Score. ETHICS AND DISSEMINATION: The study has ethical approval from the South Central Hampshire A Research Ethics Committee (19/SC/0016). All amendments will be approved by this committee. An independent trial monitoring committee is overseeing the study. Results will be made available to critical care survivors, their caregivers, the critical care societies and other researchers. TRIAL REGISTRATION NUMBER: NCT03771014.
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ItemPRehabllitatiOn with pReoperatIve exercise and educaTion for patients undergoing major abdominal cancer surgerY: protocol for a multicentre randomised controlled TRIAL (PRIORITY TRIAL)(BMC, 2022-04-22)BACKGROUND: Radical surgery is the mainstream treatment for patients presenting with advanced primary or recurrent gastrointestinal cancers; however, the rate of postoperative complications is exceptionally high. The current evidence suggests that improving patients' fitness during the preoperative period may enhance postoperative recovery. Thus, the primary aim of this study is to establish the effectiveness of prehabilitation with a progressive, individualised, preoperative exercise and education program compared to usual care alone in reducing the proportion of patients with postoperative in-hospital complications. The secondary aims are to investigate the effectiveness of the preoperative intervention on reducing the length of intensive care unit and hospital stay, improving quality of life and morbidity, and reducing costs. METHODS: This is a multi-centre, assessor-blinded, pragmatic, comparative, randomised controlled trial. A total of 172 patients undergoing pelvic exenteration, cytoreductive surgery, oesophagectomy, hepatectomy, gastrectomy or pancreatectomy will be recruited. Participants will be randomly allocated to prehabilitation with a preoperative exercise and education program (intervention group), delivered over 4 to 8 weeks before surgery by community physiotherapists/exercise physiologists, or usual care alone (control group). The intervention will comprise 12 to 24 individualised, progressive exercise sessions (including aerobic/anaerobic, resistance, and respiratory exercises), recommendations of home exercises (16 to 32 sessions), and daily incidental physical activity advice. Outcome measures will be collected at baseline, the week prior to surgery, during the hospital stay, and on the day of discharge from hospital, and 1 month and 1 months postoperatively. The primary outcome will be the development of in-hospital complications. Secondary outcomes include the length of intensive care unit and hospital stay, quality of life, postoperative morbidity and costs. DISCUSSION: The successful completion of this trial will provide robust and high-quality evidence on the efficacy of a preoperative community- and home-based exercise and education intervention on important postoperative outcomes of patients undergoing major gastrointestinal cancer surgery. TRIAL REGISTRATION: This trial was registered prospectively with the Australian New Zealand Clinical Trials Registry ( ACTRN12621000617864 ) on 24th May 2021.
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ItemENhAncing Lifestyle Behaviors in EndometriaL CancEr (ENABLE): A Pilot Randomized Controlled Trial(SAGE PUBLICATIONS INC, 2022-01-01)PURPOSE: Endometrial cancer is associated with the highest comorbid disease burden of any cancer. The aim of this trial was to assess the feasibility and safety of an allied health intervention during adjuvant treatment. METHODS: A mixed-methods pilot randomized (2:1) controlled trial with concealed allocation and assessor-blinding. Eligibility criteria: adjuvant endometrial cancer treatment scheduled, disease stage I-IIIC1, ECOG 0-2 and able to perform unsupervised physical activity (PA). Participants received usual care and 8 sessions of weekly, individualized, lifestyle education (diet and PA) with behavior change and social support (intervention group), delivered predominantly by telehealth, or usual care alone. Feasibility outcomes: recruitment and consent rates, decline reasons, program acceptability, intervention adherence and retention. RESULTS: 22/44 eligible patients (50%, 95%CI: 36%, 64%) were recruited over 10 months (14 intervention, 8 usual care). The recruitment rate was 2.2 patients/month (95%CI: 1.4, 3.3). Patients who declined had too much going on (7/22, 32%) or were not interested (6/22, 27%). Mean (SD) age and BMI were 63.2 years (6.8) and 31.9 kg/m2 (6.7). A majority were FIGO stage I (15/22, 68%) and received vaginal brachytherapy (14/22, 64%). Adherence was high, 11/14 (79%, 95%CI: 52%, 92%) participants attended >70% of scheduled sessions. Retention was 100% (95%CI: 85%, 100%) at 9 weeks, however completion of objective measures was impacted by COVID-19 restrictions. Telehealth and online questionnaires enabled participation. No serious adverse events occurred. CONCLUSION: The intervention was acceptable to participants with high levels of adherence and retention. Trial findings will be used to design a future RCT. TRIAL REGISTRATION: The trial was registered on www.anzctr.org.au (ACTRN12619000631101) 29/04/2019.
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ItemImplementability of healthcare interventions: an overview of reviews and development of a conceptual framework(BMC, 2022-01-27)BACKGROUND: Implementation research may play an important role in reducing research waste by identifying strategies that support translation of evidence into practice. Implementation of healthcare interventions is influenced by multiple factors including the organisational context, implementation strategies and features of the intervention as perceived by people delivering and receiving the intervention. Recently, concepts relating to perceived features of interventions have been gaining traction in published literature, namely, acceptability, fidelity, feasibility, scalability and sustainability. These concepts may influence uptake of healthcare interventions, yet there seems to be little consensus about their nature and impact. The aim of this paper is to develop a testable conceptual framework of implementability of healthcare interventions that includes these five concepts. METHODS: A multifaceted approach was used to develop and refine a conceptual framework of implementability of healthcare interventions. An overview of reviews identified reviews published between January 2000 and March 2021 that focused on at least one of the five concepts in relation to a healthcare intervention. These findings informed the development of a preliminary framework of implementability of healthcare interventions which was presented to a panel of experts. A nominal group process was used to critique, refine and agree on a final framework. RESULTS: A total of 252 publications were included in the overview of reviews. Of these, 32% were found to be feasible, 4% reported sustainable changes in practice and 9% were scaled up to other populations and/or settings. The expert panel proposed that scalability and sustainability of a healthcare intervention are dependent on its acceptability, fidelity and feasibility. Furthermore, acceptability, fidelity and feasibility require re-evaluation over time and as the intervention is developed and then implemented in different settings or with different populations. The final agreed framework of implementability provides the basis for a chronological, iterative approach to planning for wide-scale, long-term implementation of healthcare interventions. CONCLUSIONS: We recommend that researchers consider the factors acceptability, fidelity and feasibility (proposed to influence sustainability and scalability) during the preliminary phases of intervention development, evaluation and implementation, and iteratively check these factors in different settings and over time.
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ItemEffect of a postoperative home-based exercise and self-management programme on physical function in people with lung cancer (CAPACITY): protocol for a randomised controlled trial(BMJ PUBLISHING GROUP, 2022-01-01)INTRODUCTION: Exercise is important in the postoperative management of lung cancer, yet no strong evidence exists for delivery of home-based programmes. Our feasibility (phase I) study established feasibility of a home-based exercise and self-management programme (the programme) delivered postoperatively. This efficacy (phase II) study aims to determine whether the programme, compared with usual care, is effective in improving physical function (primary outcome) in patients after lung cancer surgery. METHODS AND ANALYSIS: This will be a prospective, multisite, two-arm parallel 1:1, randomised controlled superiority trial with assessors blinded to group allocation. 112 participants scheduled for surgery for lung cancer will be recruited and randomised to usual care (no exercise programme) or, usual care plus the 12-week programme. The primary outcome is physical function measured with the EORTC QLQ c30 questionnaire. Secondary outcomes include health-related quality of life (HRQoL); exercise capacity; muscle strength; physical activity levels and patient reported outcomes. HRQoL and patient-reported outcomes will be measured to 12 months, and survival to 5 years. In a substudy, patient experience interviews will be conducted in a subgroup of intervention participants. ETHICS AND DISSEMINATION: Ethics approval was gained from all sites. Results will be submitted for publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12617001283369.