Hybrid delivery of cluster-set resistance training for individuals previously treated for lung cancer: the results of a single-arm feasibility trial.

BACKGROUND: Individuals with non-small cell lung cancer (NSCLC) are burdened by long-lasting symptoms (e.g., dyspnea and fatigue) post-treatment. These symptoms often reduce physical activity levels and increase the risk of functional decline. Though we have previously proposed cluster-set resistance training to mitigate symptom burden in lung cancer, there is currently no data on the feasibility or acceptability of this mode of exercise in cancer. Therefore, the purpose of this study was to investigate the feasibility and acceptability of a hybrid-delivery home-based cluster-set resistance training program in individuals with NSCLC stages I-III (i.e., early stage). METHODS: This study aimed to recruit individuals with NSCLC stages I-III post-treatment to participate in 8 weeks of home-based resistance training, 3 days per week. The program included supervised sessions in the participants' homes and virtual supervision via videoconferencing. The primary outcome measure of feasibility was evaluated through recruitment, retention, and intervention fidelity (i.e., proportion of exercise completed, relative to what was prescribed). Intervention acceptability (i.e., ease and quality of virtual delivery, level of difficulty, and home-based approach) was assessed using a 4-point Likert-type scale from "strongly disagree" to "strongly agree". RESULTS: Fourteen participants were recruited over a 6-month period, with 11 completing the intervention (2 withdrew due to unrelated illness, 1 withdrew due to requiring active treatment), yielding a retention rate of 79%. Characteristics of the participants who completed the intervention (n = 11) were as follows: mean age: 71 ± 10 years, mean BMI: 29.1 ± 6.5, and average time since diagnosis was 62 ± 51 months. Of completers, 27% were male, and 36% were Black; 10 were stage I (91%), and one was stage II (9%). Mean session attendance was 86.4 ± 9.5%. Mean intervention fidelity was 83.1 ± 13.1%. With regard to acceptability, > 90% of participants positively rated all aspects of the intervention delivery. No adverse events related to exercise were recorded. CONCLUSIONS: The hybrid delivery of a home-based resistance exercise program for individuals previously treated for early-stage NSCLC was found to be safe and feasible. Adaptations to the program for future interventions are required, particularly surrounding resistance exercise programming, and intervention delivery with home visits. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05014035 . Registered January 20, 2021.

Study protocol: investigating the feasibility of a hybrid delivery of home-based cluster set resistance training for individuals previously treated for lung cancer.

BACKGROUND: Symptom burden remains a critical concern for individuals with non-small cell lung cancer (NSCLC) following the completion of treatment. The most common symptom clusters, dyspnea (shortness of breath) and fatigue, can contribute to physical decline, reductions in quality of life, and a higher risk of comorbidities and mortality. Dyspnea is a primary limiter of exercise capacity in individuals with lung cancer, resulting in exercise avoidance and an accelerated physical decline. As such, designing resistance training with cluster sets to mitigate symptoms of dyspnea and fatigue may result in improved exercise tolerance. Thus, maintaining the exercise stimulus via cluster sets, combined with improved tolerance of the exercise, could result in the maintenance of physical function and quality of life. The purpose of this study is to investigate the feasibility and preliminary efficacy of a hybrid-delivery home-based cluster-set resistance training program in individuals with NSCLC. METHODS: Individuals with NSCLC (n = 15), within 12 months of completion of treatment, will be recruited to participate in this single-arm feasibility trial. Participants will complete 8 weeks of home-based resistance training designed to minimize dyspnea and fatigue. The hybrid delivery of the program will include supervised sessions in the participants' home and virtual supervision via video conferencing. The primary outcome of feasibility will be quantified by recruitment rates, retention, acceptability, and intervention fidelity. Exploratory outcomes (dyspnea, fatigue, quality of life, physical function, and body composition) will be assessed pre- and post-intervention. DISCUSSION: This study will provide important data on the feasibility of delivering this intervention and inform procedures for a future randomized controlled trial. TRIAL REGISTRATION: Record not yet public.

Urinary aldosterone excretion and electrolytic balance in response to chronic diuretic therapy in very low-birth weight infants.

BACKGROUND: It has been reported that the reninangiotensin- aldosterone system of healthy newborn infants and pre-term infants responds to acute furosemide challenge. OBJECTIVE: To assess urinary aldosterone excretion (UAE) and electrolytic balance in very low-birth weight (VLBW) infants who received chronic therapy with furosemide and to compare them with those of infants who did not receive diuretic therapy. METHODS: Infants with birth weight <1500 g were considered eligible for this prospective observational study. On the 10th day of life, infants enrolled were divided in 2 groups on the basis of our predictive score for chronic lung disease (CLD): group 1, with positive score, received furosemide and group 2, with negative score, did not receive diuretic therapy. Urinary aldosterone and electrolytes excretion, electrolytes intakes and clearance of creatinine were investigated before the beginning of the treatment and then weekly until discharge in both groups, and results were compared. RESULTS: Thirty infants were studied: 15 received long-term furosemide and 15 did not. UAE progressively increased in infants who received furosemide whereas remained unchanged in infants who did not receive treatment. UAE was greater in group 1 than in group 2 after 3 weeks of diuretic treatment, reaching statistical significance after 4 weeks of treatment. CONCLUSIONS: In VLBW infants, chronic therapy with furosemide leads to a progressive increase in UAE that may potentially limit the diuretic effect of long-term use of furosemide in the management of CLD.

Dietary interactions and INR variability: retrospective evaluation of patients couples on oral anticoagulant therapy.

AIM: The association between dietary vitamin K intake and International Normalized Ratio (INR) variability in patients on oral anticoagulants treatment (OAT) has been evaluated in several studies. Changes in diet composition are known to lead to INR variability. We evaluated INR over time in married couples on OAT and non-cohabitant couples on OAT, to assess clinical relevance of the diet. METHODS: Among outpatients receiving OAT we selected 31 married couples. Husbands and wives were then matched by demographic and clinical characteristics to 31 men and 31 women on OAT not married nor living together. We analyzed 6,357 INR measurements recorded from February 1998 to November 2009. RESULTS: We found similar average INR values within married couples and also within non-cohabitant couples. Using mixed models we confirmed INR differences between seasons and the slightly lower INR in non-cohabitant couples compared to married couples; although statistically significant, they were of marginal clinical significance. CONCLUSION: Within both married and non-cohabitant couples, we did not find statistically or clinically significant differences between men and women over time. The lack of INR differences over time within non-cohabitant couples indicates that diet is not an important determinant of INR over time. Also seasonal INR variations and differences between married and non-cohabitant couples were of little practical importance.

Urinary aldosterone excretion and renal function in extremely-low-birth-weight infants following acute furosemide therapy.

BACKGROUND: Increased activity of the renin-angiotensin-aldosterone system (RAAS) has been reported in the neonatal period. Until now, it has been demonstrated that the RAAS of healthy neonates responds to acute furosemide challenge while no data concerning the responsiveness of RAAS in extremely low birth weight (ELBW) infants are available. OBJECTIVE: To assess urinary aldosterone excretion (UAE) and renal function in ELBW infants who received diuretics for the purpose of reducing the incidence of chronic lung disease (CLD). METHODS: Infants with birth weights < or =1,000 g, at high risk to develop CLD, were studied in a prospective observational study. UAE and renal function were investigated before and after administration of furosemide given in a single dose of 2 mg/kg. RESULTS: UAE and renal function were evaluated in 20 ELBW infants. Diuretic administration resulted in a significant rise in UAE and urinary sodium, potassium and chloride excretion. No change occurred in creatinine clearance, while urine volume increased significantly. CONCLUSIONS: ELBW infants respond to acute furosemide challenge by increasing urine volume, urinary electrolytes and UAE.

[Predictive ability of a predischarge hour-specific serum bilirubin for hyperbilirubinemia in full term infants]. / Predittività di un algoritmo previsionale dell'iperbilirubinemia neonatale nel neonato a termine.

AIM: The aim of this paper was to assess the ability of total serum bilirubin (TSB) levels in the first 3 days of life to predict subsequent nonphysiologic hyperbilirubinemia. METHODS: The predictive ability of an hour-specific nomogram for TSB values in the first week of life was prospectively assessed in 1496 full term neonates admitted to a first level neonatal unit, using a single TSB value or two consecutive ones, when available. RESULTS: The incidence of TSB values > 12 mg/dL was 9.6%, while the incidence of TSB > 15 mg/dL was 2.6%. A sensitivity of 97.9% and a negative predictive value (NPV) of 99.6% were obtained with a single bilirubin determination applying Trend 12, while 82.5% of sensitivity and 99.4% of NPV were obtained with Trend 15. Two consecutive TSB determinations identified all infants reaching TSB values > 12 mg/dL and all neonates but 5 reaching TSB values > 15 mg/dL (92.1% of sensitivity and 99% of NPV) CONCLUSION: The hour-specific TSB determination in the first 3 days of life is able to predict all neonates at risk of nonphysiologic hyperbilirubinemia and could facilitate a safe discharge from the hospital and a targeted intervention and follow-up.

Adrenocortical function and chronic lung disease of pre-maturity: an unresolved problem?

The aim of this study was to investigate the relationship between adrenocortical function and chronic lung disease (CLD) of pre-term infants. Plasma F and ACTH were measured at 7, 14, 21 and 28 days of life in 25 pre-term infants with gestational age < or = 32 weeks and birth weight < or = 1,250 g. Fourteen infants developed CLD (CLD group) and 11 recovered without CLD (NOCLD group). Response to ACTH stimulation was tested on days 7 and 28. The results show that at the 7th day of life plasma F and ACTH levels were similar in the NOCLD and CLD group. CLD group had significantly higher plasma F and ACTH concentrations at the 14th (p=0.006 for F and p=0.020 for ACTH) and at the 21st (p=0.008 for F and p=0.024 for ACTH) day of life, while no significant differences were detected at the 28th day of life. The response to ACTH stimulation test was similar between the NOCLD and CLD group. These data demonstrate the lack of any significant association between adrenal insufficiency and CLD and discourage the use of baseline or stimulated plasma F levels to predict the development of CLD in pre-term infants.

[Response of testosterone to chorionic gonadotropin stimulus in prepubertal cryptorchidism and retractile testes. Age-related changes in gonadal steroidogenesis. Authors'experience]. / La risposta del testosterone allo stimolo con gonadotropina corionica nei prepuberi criptorchidi e con testicoli retrattili. Modificazioni della steroidogenesi gonadica in rapporto all'età. Nostra esperienza.

The aim of this analysis is to evaluate the gonadal function in children with true undescended testes and in those with retractile testes, in order to verify a possible impairment of the testicular steroidogenesis due to the permanent or transitory anomalous position of the gonad outside the scrotum. The authors carried out a prospective study on 29 prepubertal children affected by true undescended testes (monolateral in 20 cases and bilateral in 9), as well as on 25 prepubertal children with retractile testes (monolateral in 10 cases and bilateral in 15), assaying the testosterone (T) levels, basal and 72 hours after stimulus with human chorionic gonadotrophin (HCG) administered in a single dose of 100 U/kg i.m. Further-more, to verify the hypothesis of a possible progressive reduction of the Leydig cells function, particularly in the gonads bilaterally affected, the authors also evaluated the testosterone response to gonadotrophic stimulus compared to age (> 0 < 4 years). This study in agreement with data already published, confirms the normality of gonadal function both in children with mono or bilateral true undescended testes and in those with retractile testes. The lower the age of the subject the higher is the peak of testosterone after stimulus, confirming the active steroidogenesis of the gonads in infants and small children and sustaining the "non quiescence" of this organ during infancy, even in cases of true undescended testes.

Acute leukemia with lymphoid/myeloid cell populations (hybrid leukemia). Case reports.

Based on conventional and immunological cell markers the great majority of acute leukemias can be classified as of lymphoid or myeloid origin. However, in some instances, leukemic cells with both lymphoid and myeloid features are found. For these cases the term of hybrid leukemia has been suggested; moreover, it has been shown that dual markers can be expressed by the same cell (biphenotypic leukemia) or myeloid and lymphoid cell populations coexist (biclonal leukemia). The accurate typing of acute leukemia is crucial in order to entail treatment and predict survival; therefore, the identification of acute hybrid leukemias may be important not only in terms of biological significance but also of management and outcome. We report here two further cases of acute hybrid leukemia with poor response to chemotherapy and very short survival.