Design of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES):A randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue

<p>Abstract</p> <p>Background</p> <p>Cancer chemotherapy is frequently associated with a decline in general physical condition, exercise tolerance, and muscle strength and with an increase in fatigue. While accumulating evidence suggests that physical activity and exercise interventions during chemotherapy treatment may contribute to maintaining cardiorespiratory fitness and strength, the results of studies conducted to date have not been consistent. Additional research is needed to determine the optimal intensity of exercise training programs in general and in particular the relative effectiveness of supervised, outpatient (hospital- or physical therapy practice-based) versus home-based programs.</p> <p>Methods</p> <p>This multicenter, prospective, randomized trial will evaluate the effectiveness of a low to moderate intensity, home-based, self-management physical activity program, and a high intensity, structured, supervised exercise program, in maintaining or enhancing physical fitness (cardiorespiratory fitness and muscle strength), in minimizing fatigue and in enhancing the health-related quality of life (HRQoL). Patients receiving adjuvant chemotherapy for breast or colon cancer (n = 360) are being recruited from twelve hospitals in the Netherlands, and randomly allocated to one of the two treatment groups or to a 'usual care' control group. Performance-based and self-reported outcomes are assessed at baseline, at the end of chemotherapy and at six month follow-up.</p> <p>Discussion</p> <p>This large, multicenter, randomized clinical trial will provide additional empirical evidence regarding the effectiveness of physical exercise during adjuvant chemotherapy in enhancing physical fitness, minimizing fatigue, and maintaining or enhancing patients' quality of life. If demonstrated to be effective, exercise intervention programs will be a welcome addition to the standard program of care offered to patients with cancer receiving chemotherapy.</p> <p>Trial registration</p> <p>This study is registered at the Netherlands Trial Register (NTR 2159)</p

Connected consciousness after tracheal intubation in young adults: an international multicentre cohort study

Background: Connected consciousness, assessed by response to command, occurs in at least 5% of general anaesthetic procedures and perhaps more often in young people. Our primary objective was to establish the incidence of connected consciousness after tracheal intubation in young people aged 18e40 yr. The secondary objectives were to assess the nature of these responses, identify relevant risk factors, and determine their relationship to postoperative outcomes. Methods: This was an international, multicentre prospective cohort study using the isolated forearm technique to assess connected consciousness shortly after tracheal intubation. Results: Of 344 enrolled subjects, 338 completed the study (mean age, 30 [standard deviation, 6.3] yr; 232 [69%] female). Responses after intubation occurred in 37/338 subjects (11%). Females (13%, 31/232) responded more often than males (6%, 6/106). In logistic regression, the risk of responsiveness was increased with female sex (odds ratio [OR adjusted ]¼2.7; 95% confidence interval [CI], 1.1e7.6; P¼0.022) and was decreased with continuous anaesthesia before laryngoscopy (OR adjusted ¼0.43; 95% CI, 0.20e0.96; P¼0.041). Responses were more likely to occur after a command to respond (and not to nonsense, 13 subjects) than after a nonsense statement (and not to command, four subjects, P¼0.049). Conclusions: Connected consciousness occured after intubation in 11% of young adults, with females at increased risk. Continuous exposure to anaesthesia between induction of anaesthesia and tracheal intubation should be considered t

Comment on Mankowska et al. Critical Flicker Fusion Frequency: A Narrative Review. Medicina 2021, 57, 1096

We have read with great interest the review by Mankowska et al. [...

Investigating critical flicker fusion frequency for monitoring gas narcosis in divers.

Critical flicker fusion frequency (CFFF) has been used in various studies to measure the cognitive effects of gas mixtures at depth, sometimes with conflicting or apparently paradoxical results. This study aimed to evaluate a novel automatic CFFF method and investigate whether CFFF can be used to monitor gas-induced narcosis in divers.info:eu-repo/semantics/publishe

Adherence to and satisfaction with low-intensity physical activity and supervised moderate-high intensity exercise during chemotherapy for breast cancer

Purpose: In this study, we investigated factors associated with program adherence and patient satisfaction with a home-based physical activity program (Onco-Move, N = 77) and a supervised exercise program with a home-based component (OnTrack, N = 76). Methods: We assessed adherence via self-report (home-based program) and attendance records (supervised program). We used logistic regression analysis to identify sociodemographic, clinical and behavioural variables associated with program adherence. Patient satisfaction was assessed with self-report and is reported descriptively. Results: Fifty-one percent of Onco-Move and 62% of OnTrack participants were adherent to the home-based program, while 59% of OnTrack participants were adherent to the supervised sessions. Higher baseline physical fitness was associated with higher adherence to home-based components. Higher disease stage and having a partner were associated with adherence to OnTrack supervised sessions. Overall satisfaction with the exercise programs was high, but ratings of coaching provided by professionals for the home-based components were low. Patients offered suggestions for improving delivery of the programs. Conclusions: These findings point to factors relevant to program adherence and suggest ways in which such programs can be improved. Providing additional time and training for health care professionals could improve the quality and hopefully the effectiveness of the interventions. The use of online diaries and smartphone apps may provide additional encouragement to participants. Finally, allowing greater flexibility in the planning and availability of supervised exercise training in order to accommodate the variability in cancer treatment schedules and the (acute) side effects of the treatments could also enhance program adherence. Trial registration: Netherlands Trial Register, NTR2159. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2159

Cost–utility and cost-effectiveness of physical exercise during adjuvant chemotherapy

Introduction: A home-based, low-intensity physical activity program (Onco-Move) and a supervised, moderate-to-high intensity, combined resistance and aerobic exercise program (OnTrack) have proven to be effective in maintaining physical fitness and reducing fatigue among breast cancer patients undergoing adjuvant chemotherapy. This study evaluated the cost–utility and cost-effectiveness of Onco-Move and OnTrack. Methods: A total of 230 patients were randomized to Onco-Move, OnTrack, or usual care (UC). Health outcomes included quality-adjusted life years (QALYs), general and physical fatigue, and physical fitness measured at baseline, end of chemotherapy, and 6-month follow-up. Societal costs included professional and informal health care, work absenteeism, and unpaid productivity costs. Cost data were based on 3-monthly questionnaires, supplemented by medication data obtained from pharmacies. Results: Onco-Move is not likely to be cost-effective due to the relatively high willingness-to-pay necessary to reach reasonable probabilities of cost-effectiveness (QALY, general and physical fatigue). Incremental cost-effectiveness ratios for OnTrack compared to UC were €26,916/QALY, €788/1-point decrease in general fatigue and €1402/1-point decrease in physical fatigue. The probability of OnTrack being cost-effective ranged from 31% at a willingness-to-pay (WTP) of €0–79% at a WTP of €80,000/QALY, 97% at a WTP of €15,000/1-point decrease in general fatigue, and 86% at a WTP of €24,000/1-point decrease in physical fatigue. Both interventions had a low probability of being cost-effective for physical fitness. The probability of cost-effectiveness for both interventions was greater among compliant participants. Conclusions: Onco-Move is not likely to be cost-effective. Depending on the decision-makers’ willingness-to-pay, OnTrack could be considered cost-effective in comparison with UC. Trial registration Clinical trial registration number of the Netherlands Trial Register—NTR2159

Recruitment to and pilot results of the PACES randomized trial of physical exercise during adjuvant chemotherapy for colon cancer

We report the recruitment rate, reasons for and factors influencing non-participation, and descriptive results of a randomized controlled trial of two different exercise programs for patients with colon cancer undergoing adjuvant chemotherapy. Participants were randomized to a low-intensity, home-based program (Onco-Move), a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack), or Usual Care. Non-participants provided reasons for non-participation and were asked to complete a questionnaire assessing behavioral and attitudinal variables. Trial participants completed performance-based and self-reported outcome measures prior to randomization, at the end of chemotherapy, and at the 6-month follow-up. Twenty-three of 63 referred patients agreed to participate in the trial. All 40 non-participants provided reasons for non-participation. Forty-five percent of the non-participants completed the questionnaire. Those who did not want to exercise had higher fatigue scores at baseline and a more negative attitude toward exercise. Compliance to both programs was high and no adverse events occurred. On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up. Recruitment of patients with colon cancer to a physical exercise trial during adjuvant chemotherapy proved to be difficult, underscoring the need to develop more effective strategies to increase participation rates. Both home-based and supervised programs are safe and feasible in patients with colon cancer undergoing chemotherapy. Effectiveness needs to be established in a larger trial. Netherlands Trial Register - NTR215