Optimising symptom management in children with cancer using a novel mobile phone application: protocol for a controlled hybrid effectiveness implementation trial (RESPONSE)

Abstract Background Intense and aggressive treatment regimens for most children’s cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability. Methods A pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability. Trial registration number ACTRN12621001084875. Retrospectively Registered 16 August 2021.

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Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: protocol for a multicentre, randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-030041 ◽

2019 ◽

Vol 9 (8) ◽

pp. e030041

Author(s):

Wei Dai ◽

Yuanqiang Zhang ◽

Wenhong Feng ◽

Xiaoqing Liao ◽

Yunfei Mu ◽

...

Keyword(s):

Lung Cancer ◽

Symptom Management ◽

Controlled Trial ◽

Randomised Trial ◽

Intervention Group ◽

Postoperative Recovery ◽

Control Group ◽

Oncological Treatment ◽

Study Results ◽

Patient Reported

IntroductionSurgery is one of the primary treatments for lung cancer. The postoperative symptom burden experienced by patients with lung cancer is substantial, seriously delaying their recovery from surgery and impairing their quality of life. Patient-reported outcome (PRO)-based symptom management is increasingly regarded as an optimal model for patient-centred care. Currently, clinical trial-based evidence involving early-phase (immediately after surgery for up to 1 month) symptom management of lung cancer is lacking. We propose a randomised trial to evaluate the effect of a PRO-based symptom-monitoring programme with overthreshold alerts and responses for postoperative recovery in patients with lung cancer.Methods and analysisThe study will recruit 160 patients with lung cancer from six hospitals. The patients will be randomly allocated to the intervention group or control group in a ratio of 1:1. Patients in the intervention group will receive PRO-based symptom management from the specialists when their reported target symptom (pain, coughing, fatigue, disturbed sleep and shortness of breath) scores reach the preset threshold (score ≥4). Patients in the control group will not generate alerts and will follow the standard procedures for symptom management. All patients will receive symptom assessments via the MD Anderson Symptom Inventory—lung cancer module on the day before surgery, daily after surgery and twice a week after discharge until 4 weeks or the start of postoperative oncological treatment. The primary outcome—mean symptom threshold events—will be compared between the intervention and control group via independent sample Student’s t-test.Ethics and disseminationThe study was approved by the Ethics Committee of Sichuan Cancer Hospital on 22 November 2018 (No. SCCHEC-02-2018-045). This manuscript is based on V.2.0, 9 May 2019 of the protocol. The study results will be disseminated in publications in peer-reviewed journals and presentations at academic conferences.Trials registration numberChiCTR1900020846.

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Smartphone-Based Meditation for Myeloproliferative Neoplasm Patients: Feasibility Study to Inform Future Trials (Preprint)

10.2196/preprints.12662 ◽

2018 ◽

Author(s):

Jennifer Huberty ◽

Ryan Eckert ◽

Linda Larkey ◽

Jonathan Kurka ◽

Sue A Rodríguez De Jesús ◽

...

Keyword(s):

Physical Health ◽

Sleep Disturbance ◽

Controlled Trial ◽

Myeloproliferative Neoplasm ◽

Symptom Burden ◽

Patient Reported Outcome ◽

Pharmacologic Therapy ◽

Control Group ◽

Limited Efficacy ◽

Patient Reported

BACKGROUND Myeloproliferative neoplasm (MPN) patients often report high symptom burden that persists despite the best available pharmacologic therapy. Meditation has gained popularity in recent decades as a way to manage cancer patient symptoms. OBJECTIVE The aim of this study was to examine the feasibility of 2 different consumer-based meditation smartphone apps in MPN patients and to examine the limited efficacy of smartphone-based meditation on symptoms compared with an educational control group. METHODS Patients (n=128) were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into 1 of 4 groups, 2 of which received varying orders of 2 consumer-based apps (10% Happier and Calm) and 2 that received one of the apps alone for the second 4 weeks of the 8-week intervention after an educational control condition. Participants were asked to perform 10 min of meditation per day irrespective of the app and the order in which they received the apps. Feasibility outcomes were measured at weeks 5 and 9 with a Web-based survey. Feasibility outcomes were acceptability, demand, and limited efficacy for depression, anxiety, pain intensity, sleep disturbance, sexual function, quality of life, global health, and total symptom burden. RESULTS A total of 128 patients were enrolled across all 4 groups, with 73.4% (94/128) patients completing the intervention. Of the participants who completed the 10% Happier app, 61% (46/76) enjoyed it, 66% (50/76) were satisfied with the content, and 77% (59/76) would recommend to others. Of those who completed the Calm app, 83% (56/68) enjoyed it, 84% (57/68) were satisfied with the content, and 97% (66/68) would recommend to others. Of those who completed the educational control, 91% (56/61) read it, 87% (53/61) enjoyed it, and 71% (43/61) learned something. Participants who completed the 10% Happier app averaged 31 (SD 33) min/week; patients completing the Calm app averaged 71 (SD 74) min/week. 10% Happier app participants saw small effects on anxiety (P<.001 d=−0.43), depression (P=.02; d=−0.38), sleep disturbance (P=.01; d=−0.40), total symptom burden (P=.13; d=−0.27), and fatigue (P=.06; d=−0.30), and moderate effects on physical health (P<.001; d=0.52). Calm app participants saw small effects on anxiety (P=.29; d=−0.22), depression (P=.09; d=−0.29), sleep disturbance (P=.002; d=−0.47), physical health (P=.005; d=0.44), total symptom burden (P=.13; d=−0.27), and fatigue (P=.13; d=−0.27). Educational control participants (n=61) did not have effects on any patient-reported outcome except for a moderate effect on physical health (P<.001; d=0.77). CONCLUSIONS Delivering meditation via the Calm app is feasible and scored higher in terms of feasibility when compared with the 10% Happier app. The Calm app will be used to implement a randomized controlled trial, testing the effects of meditation on symptom burden in MPNs. CLINICALTRIAL ClinicalTrials.gov NCT03726944; https://clinicaltrials.gov/ct2/show/NCT03726944 (Archived by WebCite at http://www.webcitation.org/77MVdFJwM)

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Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.21.01344 ◽

2022 ◽

Author(s):

Wei Dai ◽

Wenhong Feng ◽

Yuanqiang Zhang ◽

Xin Shelley Wang ◽

Yangjun Liu ◽

...

Keyword(s):

Lung Cancer ◽

Usual Care ◽

Symptom Management ◽

Intervention Group ◽

Lung Cancer Surgery ◽

Patient Reported Outcome ◽

Cancer Surgery ◽

Interquartile Range ◽

Control Group ◽

Patient Reported

PURPOSE We aimed to evaluate the efficacy and feasibility of patient-reported outcome (PRO)-based symptom management in the early period after lung cancer surgery. METHODS Before surgery, patients with clinically diagnosed lung cancer were randomly assigned 1:1 to receive postoperative PRO-based symptom management or usual care. All patients reported symptoms on MD Anderson Symptom Inventory-Lung Cancer presurgery, daily postsurgery, and twice a week after discharge for up to 4 weeks via an electronic PRO system. In the intervention group, treating surgeons responded to overthreshold electronic alerts driven by any of the five target symptom scores (score ≥ 4 on a 0-10 scale for pain, fatigue, disturbed sleep, shortness of breath, and coughing). The control group patients received usual care and no alerts were generated. The primary outcome was the number of symptom threshold events (any target symptom with a score of ≥ 4) at discharge. Per-protocol analyses were conducted. RESULTS Of the 166 participants, 83 were randomly allocated to each group. At discharge, the intervention group reported fewer symptom threshold events than the control group (median [interquartile range], 0 [0-2] v 2 [0-3]; P = .007). At 4 weeks postdischarge, this difference was maintained between the intervention and control groups (median [interquartile range], 0 [0-0] v 0 [0-1]; P = .018). The intervention group had a lower complication rate than the control group (21.5% v 40.6%; P = .019). Surgeons spent a median of 3 minutes managing an alert. CONCLUSION PRO-based symptom management after lung cancer surgery showed lower symptom burden and fewer complications than usual care for up to 4 weeks postdischarge.

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Treatment with and without stabilizing lumbar spinal orthosis after one- or two-level spondylodesis: A randomized controlled trial

Technology and Health Care ◽

10.3233/thc-191820 ◽

2020 ◽

Vol 28 (5) ◽

pp. 541-549

Author(s):

Yorck Rommelspacher ◽

Hannah Bode ◽

Jana Ziob ◽

Charlotte Struwe ◽

Adnan Kasapovic ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Control Group ◽

Patient Reported ◽

Subjective Pain ◽

Postoperative Mobility ◽

Lumbar Spinal ◽

Spinal Orthosis

BACKGROUND AND OBJECTIVE: Musculature affected during spondylodesis surgery may benefit and recover faster if supported by spine orthosis postoperatively. METHODS: This prospective study included 50 consecutive patients undergoing one- or two-level spondylodesis. The intervention group received a lumbar spine orthosis (n= 23), while the control group remained without orthosis (n= 27). Patients were assessed for pain (Visual Analogue Scale, VAS), Oswestry Disability index (ODI) as well as the use of analgesics. RESULTS: Patients wearing an orthosis postoperatively reported a higher degree of subjective stability. However, both intervention as well as control group did not show any significant differences for each of the follow-up points regarding VAS, ODI or the use of analgesics. CONCLUSION: Wearing an orthosis has neither impact on subjective pain, the need for analgesics nor for postoperative functionality. However, patients reported that they profited from wearing the orthosis by feeling more stable, thereby nicely improving their postoperative mobility. Thus, novel patient reported outcome measures have to be developed to assess these features in future studies.

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Effect of conversations about values and goals on anxiety in patients.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.29_suppl.9 ◽

2015 ◽

Vol 33 (29_suppl) ◽

pp. 9-9 ◽

Cited By ~ 2

Author(s):

Joanna Paladino ◽

Rachelle Bernacki ◽

Mathilde Hutchings ◽

Stuart R. Lipsitz ◽

Bridget A. Neville ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Positive Behavior ◽

Control Group ◽

Behavior Changes ◽

Patient Anxiety ◽

Patient Acceptability ◽

Serious Illness ◽

Risk Of Death ◽

Patient Reported

9 Background: Patients with serious illness routinely receive treatments that do not align with their goals. Earlier clinical conversations about patients’ values and priorities lead to more goal-concordant care and improved quality of life, but clinician concerns about harming patients and taking away hope are barriers to appropriately timed discussions. Methods: A cluster-randomized controlled trial with oncology patients at high risk of death, identified by the surprise question. The intervention included a structured, patient-centered discussion about values and priorities conducted by trained oncology clinicians using the Serious Illness Conversation Guide. Patient anxiety (GAD-7) was measured by survey at baseline and every 2 months; anxiety, patient acceptability, and patient-reported behavior change were measured by survey 1 week after the intervention and at a matching time point for controls. Results: 342 patients enrolled (median age 62y): 176 intervention; 166 control. 102 conversations were completed in the intervention group. The mean anxiety (GAD-7) score prior to the intervention in the intervention group was 3.75 and in the control group was 3.80 (p = 0.72). However, a week after the intervention conversation (on average, the conversation was 10.4 weeks from baseline, IQR 3-13 weeks), there were significant differences. At 11.4 weeks, the intervention anxiety mean was 2.87, and the control mean was 4.26 (p = 0.011). Reductions persisted for 2 months after the conversation. Among patients who had the serious illness conversation and completed the acceptability survey: 86% reported that the conversation was worthwhile; 66% reported positive behavior changes as a result of the discussion; more than 80% reported that their hopefulness, peacefulness, and sense of control over medical decisions increased or did not change. Conclusions: The Serious Illness conversation lowered patient anxiety; this reduction was sustained for at least 2 months after the conversation. Patients viewed the serious illness conversation as worthwhile and reported enacting concrete positive behavior changes as a result of the discussion. Clinical trial information: NCT01786811.

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The effectiveness of Kinesio Taping® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520916859 ◽

2020 ◽

Vol 34 (7) ◽

pp. 877-889 ◽

Cited By ~ 1

Author(s):

Venta Donec ◽

Raimondas Kubilius

Keyword(s):

Knee Osteoarthritis ◽

Controlled Trial ◽

Intervention Group ◽

Outpatient Rehabilitation ◽

Control Group ◽

Double Blind ◽

Kinesio Taping ◽

Patient Reported ◽

Double Blinded

Objective: To evaluate the effectiveness of the Kinesio Taping® method for mobility and functioning improvement for patients with knee osteoarthritis (KO). Design: Randomized, double-blinded, controlled trial. Setting: Outpatient rehabilitation department. Subjects: A total of 187 subjects with symptomatic I–III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n = 81 (123 knees); control group, n = 76 (114 knees). Intervention: The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month. Main measures: Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants’ experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was p < 0.05. Results: The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was –2.2 ± 3.2 seconds, at follow-up –2.4 ± 3.1 seconds; in control group –2.8 ± 3.6 seconds, and –2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16), χ2 = 7.5, df = 2, p = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p < 0.005). Conclusion: Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.

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Effect of Leg Length–Evening Device on Perceived Balance in Patients Wearing a Controlled Ankle Motion Boot

Foot & Ankle Orthopaedics ◽

10.1177/2473011420930236 ◽

2020 ◽

Vol 5 (3) ◽

pp. 247301142093023

Author(s):

Nasima Mehraban ◽

Alexander J. Idarraga ◽

Kevin J. Wu ◽

Milap S. Patel ◽

Anand M. Vora ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Leg Length ◽

Ankle Motion ◽

Plantar Aspect ◽

Total Pain ◽

Multicenter Randomized Controlled Trial ◽

Patient Reported

Background: Patients are often made weightbearing as tolerated (WBAT) in a controlled ankle motion (CAM) boot for the management of various foot and ankle conditions. The CAM boot causes a leg length discrepancy (LLD) between the booted (longer) and contralateral (shorter) lower extremities. This discrepancy can potentially cause balance problems, undue strain on joints, and discomfort in patients. We hypothesized that a leg length–evening orthotic placed on the plantar aspect of the contralateral shoe improves balance among patients who are WBAT in a CAM boot. Methods: Patients made WBAT in a CAM boot were randomized to either the leg length–evening orthotic intervention group or to a control group in which patients wore a normal shoe of their choice. Patients were followed for 2 weeks and asked a series of questions pertaining to balance and pain experienced at their knees, hips, and back. Balance was the primary outcome and was scored from 0 (no difficulty with balance) to 10 (great difficulty with balance). Of 107 subjects enrolled and randomized, 95 (88.8%) completed the study, satisfying the a priori sample size requirement of 94 patients. There were no differences in baseline characteristics between groups ( P > .05 for each). Results: Intervention patients reported less difficulty with balance than control patients (intention-to-treat analysis: 2.0±1.5 vs 3.2±1.8, P = .001; as-treated analysis: 2.1±1.7 vs 3.0±1.7, P = .009). Intervention and control patients did not differ with respect to pain experienced at their knees, hips, or back, or in a composite total pain score ( P > .05 for each). Conclusion: This multicenter randomized controlled trial found that adding a limb length–evening orthotic to the plantar aspect of the contralateral shoe in a patient that is WBAT in a CAM boot improved patient-reported self-assessment of balance. The trial was powered to identify a difference in the primary outcome measure of balance and may have been insufficiently powered to identify differences in knee, hip, back, or total pain. Level of Evidence: Level II, prospective comparative study.

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Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3772-y ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Hailong Zhang ◽

Jiansheng Li ◽

Xueqing Yu ◽

Suyun Li ◽

Haifeng Wang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Chinese Medicine ◽

Short Form ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Patient Reported ◽

Acute Exacerbations

Abstract Background The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. AECOPD have been effectively treated with Chinese medicine for a long time. The aim of this proposed trial is to assess the therapeutic effect of Chinese medicine (CM) on AECOPD. Methods/design This proposed study is a multicenter, double-blind, parallel-group randomized controlled trial (RCT). We will randomly assign 378 participants with AECOPD into two groups in a 1:1 ratio. On the basis of health education and conventional treatment, the intervention group will be treated with CM, and the control group is given CM placebo according to CM syndrome. Patients are randomized to either receive CM or placebo, 10 g/packet, twice daily. The double-blind treatment lasts for 2 weeks and is followed up for 4 weeks. The main outcome is the COPD Assessment Test; secondary outcomes are treatment failure rate, treatment success rate, length of hospital stay, AECOPD readmission rate, intubation rate, mortality, dyspnea, the 36-item Short Form Health Survey, and the COPD patient-reported outcome scale. We will document these outcomes faithfully at the beginning of the study, 2 weeks after treatment, and at the 4 weeks follow-up. Discussion This high-quality RCT with strict methodology and few design deficits will help to prove the effectiveness of CM for AECOPD. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD. Trial registration ClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.

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Home-based Palliative Intervention to Improve Quality of Life in Children with Cancer: A Randomized Controlled Trial

10.21203/rs.2.18923/v1 ◽

2019 ◽

Author(s):

Murti Andriastuti ◽

Pricilia G Halim ◽

Elnino Tunjungsari ◽

Dwi P Widodo

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Children With Cancer ◽

Randomized Controlled ◽

Home Based ◽

Significant Difference

Abstract Background: In these last few years, an integrated approach between palliative care (PC) and chronic and/or life-threatening conditions care have been widely used. Home-based PC service is developed to meet the needs of the patients at home, but hasn’t been applied widely. This study is aimed to determine the benefit of integrated home-based PC in the quality of life (QOL) and symtomps intensity of Indonesian children with malignancies. Method: A randomized controlled trial to compare the quality of life between patients who were given PC (a 3-month home visit) and those who were not (intervention vs control group) was conducted, each group containing 30 children with cancer aged 2-18 years old who were consulted to palliative team. Participants were randomly assigned into each group. In the first and twelfth week of the intervention, all patients were assessed with the Pediatric Quality of Life Inventory (PedsQLTM) questionnaire cancer module 3.0 (report by proxy or self-report). Symptoms intensity (pain, anorexia, sleep disturbance) were scored by using Edmonton Symptoms Assessment Scale (ESAS). Mean score and each dimension score of both group were compared and analyzed using bivariate analysis. Results: A total 50 participants were included in analysis. Significant difference was found between two groups with average total score in control group 62.39 and intervention group 81.63 (p<0.001). In the intervention group QoL tends to improve, whereas in the control group, those did not get palliative intervention, quality of life tends to decrease as the disease progress. The most improved aspect in QoL is pain and nausea (p<0.001), followed by procedural anxiety (p=0.002), treatment anxiety (p=0.002), and worry (p=0.014). Palliative intervention was found to be able to reduce sleep disturbances (p=0.003) and anorexia (p<0.001) significantly. Conclusion: Home-based PC improved several aspects of the QOL and provide better symptoms management of children with malignancies. An early intervention concurrent with the underlying treatment is believed to be able to improve their quality of life. Trial Registration: This study has been retrospectively registered in ClinicalTrials.gov ID: NCT04067687 (August, 22nd 2019).

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Efficacy of preoperative progressive resistance training in patients undergoing total knee arthroplasty: 12-month follow-up data from a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215519883420 ◽

2019 ◽

Vol 34 (1) ◽

pp. 82-90 ◽

Cited By ~ 1

Author(s):

Birgit Skoffer ◽

Thomas Maribo ◽

Inger Mechlenburg ◽

Christian Gaarden Korsgaard ◽

Kjeld Søballe ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Resistance Training ◽

Muscle Strength ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Significant Group ◽

Randomized Controlled ◽

Patient Reported

Objective: The aim of this study was to investigate the effect of adding four weeks preoperative progressive resistance training (PRT) to four weeks postoperative PRT on patient function, muscle strength, and other outcomes 12 months after total knee arthroplasty (TKA). Design: Twelve-month follow-up data from a previously published randomized controlled trial. Setting: Aarhus University Hospital, Silkeborg Regional Hospital, and Aarhus University. Subjects: A total of 59 patients scheduled for TKA were enrolled in a single-blinded, clinical randomized controlled trial. Interventions: Participants were randomized to preoperative PRT (intervention group) or to a control group who “lived as usual” the last four weeks before TKA. The intervention group completed four weeks preoperative and four weeks postoperative PRT, whereas the control group only completed four weeks postoperative PRT. Main follow-up measures were as follows: the 30-second Chair Stand Test (primary outcome), Timed Up and Go Test, walk tests, knee extensor, and knee flexor muscle strength and patient-reported outcomes. Statistical analyses were performed according to the intention-to-treat principle. Results: No significant group differences were observed for the primary outcome 30-second Chair Stand Test (4.0 repetitions versus 2.4 repetitions, P = 0.067) or for other functional performance outcomes. The intervention group had significantly higher weight-normalized knee extensor muscle strength (0.5 Nm/kg versus 0.2 Nm/kg, P = 0.002) and knee flexor muscle strength (0.3 Nm/kg versus 0.2 Nm/kg, P = 0.042) in the operated leg when compared to the control group. No significant group differences for patient-reported outcomes. Conclusion: The study supports the use of short-term high-intensity resistance training before TKA as it induces a long-lasting effect on muscle strength, while it may have no discernible effect on functional performance.

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