Bewegungsempfehlung bei Chemothrapie-induzierter peripherer Polyneuropathie

Die Chemothrapie-induzierte periphere Polyneuropathie (CIPN) ist eine der relvantesten Therapie-assoziierten Nebenwirkungen. Sie führt zu motorischen und sensorischen Dysfunktionen, die zum einen die Lebensqualität der Patienten reduzieren und zum anderen die medizinische Therapie beeinträchtigen. Derzeit besteht kein effektives Behandlungskonzept zur Behandlung der CIPN. Vielversprechend ist derzeit die Sporttherapie. Basierend auf dem aktuellsten wissenschafftlichen Stand bieten sowohl Sensomotoriktraining als auch Vibrationstraining das Potenzial, motorische und sensorische Symptome der CIPN zu reduzieren

Design of a RCT evaluating a lifestyle intervention in patients with type 2 diabetes and a critical appraisal of the recruitment process

Introduction Changing lifestyle can delay the progression of type 2 diabetes (T2D). Although there are evidence-based recommendations on diet and physical activity (PA; Colberg et al., 2016; Evert et al., 2019), T2D patients have difficulties implementing them (Booth, et al., 2013). Therefore, we have developed an intervention to promote PA and a healthy diet. While providing a supportive lifestyle change program for T2D patients, the recruitment entails difficulties. Objective The objective is to describe the design of the study and the intervention. As the study is still ongoing, the screening and recruitment process is to be analysed in more detail. Methods The intervention is investigated in a two-arm randomised controlled trial with N = 90 participants. Participants of the intervention group receive a one-year personal health coaching via telephone and access to an application. The intervention adapts the lifestyle recommendations to the individual needs based on achievable goals. The motivation and volition concept and behavior change techniques are used to empower participants to implement a healthy lifestyle. The control group receives access to the application. Primary outcomes are objectively measured PA and HbA1c. All outcomes are measured at baseline, at 27 weeks after inclusion and at 54 weeks after inclusion. Since May 2021, patients with T2D have been screened in two hospitals according to the study criteria (Hohberg et al., 2022). Due to a small number of eligible and interested patients, the criteria were adjusted in the course of the study and recruitment strategies were evaluated and adapted. Results Before the amendment of the inclusion criteria, 6.4% (113/1776; 05/2021-01/2022), and after the amendment, 22% (274/1243; 02/2022-10/2022) of T2D patients were eligible for the study. Finally, 1.8% (54/3019) of screened and 14% (54/387) of patients eligible for the study could be included. Reasons leading to a decline in participation are still being reviewed up to the conference. Exemplary reasons are e.g. no motivation, no time or too much stress, the program is not suitable for them or they are no longer contactable. Conclusion A strict definition of inclusion criteria as it is common in clinical trials with T2D patients results in only a very small part of the patients treated in the hospital being eligible for the study. Of these patients, only a few have interest or capacity to participate in the study. Researchers planning lifestyle interventions for T2D patients need to critically reflect on inclusion criteria and the recruitment process in order to obtain study results which are finally applicable to the real-world clinical population. References Booth, A. O., Lowis, C., Dean, M., Hunter, S. J., & McKinley, M. C. (2013). Diet and physical activity in the self-management of type 2 diabetes: barriers and facilitators identified by patients and health professionals. Primary Health Care Research & Development, 14(3), 293-306. https://doi.org/10.1017/S1463423612000412 Colberg, S. R., Sigal, R. J., Yardley, J. E., Riddell, M. C., Dunstan, D. W., Dempsey, P. C., Horton, E. S., Castorino, K., & Tate, D. F. (2016). Physical activity/exercise and diabetes: A position statement of the American Diabetes Association. Diabetes Care, 39(11), 2065-2079. https://doi.org/10.2337/dc16-1728 Evert, A. B., Dennison, M., Gardner, C. D., Garvey, W. T., Lau, K. H. K., MacLeod, J., Mitri, J., Pereira, R. F., Rawlings, K., Robinson, S., Saslow, L., Uelmen, S., Urbanski, W. S., & Yancy Jr., W. S. (2019). Nutrition therapy for adults with diabetes or prediabetes: A consensus report. Diabetes Care, 42(5), 731-754. https://doi.org/10.2337/dci19-0014 Hohberg, V., Kreppke, J.-N., Kohl, J., Seelig, E., Zahner, L., Streckmann, F., Gerber, M., König, D., & Faude, O. (2022). Effectiveness of a personal health coaching intervention (diabetescoach) in patients with type 2 diabetes: Protocol for an open-label, pragmatic randomised controlled trial. BMJ Open, 12(6), Article e057948. https://doi.org/10.1136/bmjopen-2021-05794

Whole-body vibration in children with disabilities demonstrates therapeutic potentials for pediatric cancer populations: a systematic review

PurposeLow levels of physical activity often observed in pediatric oncology might be attributed to various functional deficits, especially those of the lower limbs as these affect gait, mobility, and, consequently, physical activity. In the past few years, whole-body vibration (WBV) has emerged as a new therapy modality for improving physical functioning. Although WBV is increasingly applied in children with disabilities, its impact on lower limb function in pediatric cancer patients and survivors has not yet been investigated.MethodsTo establish whether there is evidence that WBV may be beneficial for pediatric cancer patients and survivors, this review summarizes current data on WBV studies among children with disabilities and extracts relevant information for the pediatric cancer population. Two independent reviewers performed a systematic literature search following the PRISMA guidelines.ResultsNine studies were included in the analysis. Results demonstrate that WBV is a safe, highly compliant, and effective approach in cohorts of children with disabilities. The largest effects of WBV were observed in lower extremity muscle mass and strength, balance control, gait, and walking ability. Furthermore, we were able to develop first recommendations for WBV protocols.ConclusionsWBV seems to be feasible and effective for improving parameters that may be relevant to the pediatric cancer population. Efforts are needed to conduct first WBV interventions in children with cancer proving the effects. The developed recommendations for WBV protocols might help to implement these intervention studies

Aerobic physical exercise for adult patients with haematological malignancies

Background Although people with haematological malignancies have to endure long phases of therapy and immobility, which is known to diminish their physical performance level, the advice to rest and avoid intensive exercises is still common practice. This recommendation is partly due to the severe anaemia and thrombocytopenia from which many patients suffer. The inability to perform activities of daily living restricts them, diminishes their quality of life and can influence medical therapy. Objectives In this update of the original review (published in 2014) our main objective was to re-evaluate the efficacy, safety and feasibility of aerobic physical exercise for adults suffering from haematological malignancies considering the current state of knowledge. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2018, Issue 7) and MEDLINE (1950 to July 2018) trials registries (ISRCTN, EU clinical trials register and clinicaltrials.gov) and conference proceedings. We did not apply any language restrictions. Two review authors independently screened search results, disagreements were solved by discussion. Selection criteria We included randomised controlled trials (RCTs) comparing an aerobic physical exercise intervention, intending to improve the oxygen system, in addition to standard care with standard care only for adults suffering from haematological malignancies. We also included studies that evaluated aerobic exercise in addition to strength training. We excluded studies that investigated the effect of training programmes that were composed of yoga, tai chi chuan, qigong or similar types of exercise. We also excluded studies exploring the influence of strength training without additive aerobic exercise as well as studies assessing outcomes without any clinical impact. Data collection and analysis Two review authors independently screened search results, extracted data and assessed the quality of trials. We used risk ratios (RRs) for adverse events, mortality and 100-day survival, standardised mean differences (SMD) for quality of life (QoL), fatigue, and physical performance, and mean differences (MD) for anthropometric measurements. Main results In this update, nine trials could be added to the nine trials of the first version of the review, thus we included eighteen RCTs involving 1892 participants. Two of these studies (65 participants) did not provide data for our key outcomes (they analysed laboratory values only) and one study (40 patients) could not be included in the meta-analyses, as results were presented as changes scores only and not as endpoint scores. One trial (17 patients) did not report standard errors and could also not be included in meta-analyses. The overall potential risk of bias in the included trials is unclear, due to poor reporting. The majority of participants suffered from acute lymphoblastic leukaemia (ALL), acutemyeloid leukaemia (AML), malignant lymphoma and multiple myeloma, and eight trials randomised people receiving stem cell transplantation. Mostly, the exercise intervention consisted of various walking intervention programmes with different duration and intensity levels. Our primary endpoint overall survival (OS) was only reported in one of these studies. The study authors found no evidence for a difference between both arms (RR = 0.67; P = 0.112). Six trials (one trial with four arms, analysed as two sub-studies) reported numbers of deceased participants during the course of the study or during the first 100 to 180 days. For the outcome mortality, there is no evidence for a difference between participants exercising and those in the control group (RR 1.10; 95% CI 0.79 to 1.52; P = 0.59; 1172 participants, low-certainty evidence). For the following outcomes, higher numbers indicate better outcomes, with 1 being the best result for the standardised mean differences. Eight studies analysed the influence of exercise intervention on QoL. It remains unclear, whether physical exercise improves QoL (SMD 0.11; 95% CI -0.03 to 0.24; 1259 participants, low-certainty evidence). There is also no evidence for a difference for the subscales physical functioning (SMD 0.15; 95% CI -0.01 to 0.32; 8 trials, 1329 participants, low-certainty evidence) and anxiety (SMD 0.03; 95% CI -0.30 to 0.36; 6 trials, 445 participants, very low-certainty evidence). Depression might slightly be improved by exercising (SMD 0.19; 95% CI 0.0 to 0.38; 6 trials, 445 participants, low-certainty evidence). There is moderate-certainty evidence that exercise probably improves fatigue (SMD 0.31; 95% CI 0.13 to 0.48; 9 trials, 826 patients). Six trials (435 participants) investigated serious adverse events. We are very uncertain, whether additional exercise leads to more serious adverse events (RR 1.39; 95% CI 0.94 to 2.06), based on very low-certainty evidence. In addition, we are aware of four ongoing trials. However, none of these trials stated, how many patients they will recruit and when the studies will be completed, thus, potential influence of these trials for the current analyses remains unclear. Authors' conclusions Eighteen, mostly small RCTs did not identify evidence for a difference in terms of mortality. Physical exercise added to standard care might improve fatigue and depression. Currently, there is inconclusive evidence regarding QoL, physical functioning, anxiety and SAEs. We need further trials with more participants and longer follow-up periods to evaluate the effects of exercise intervention for people suffering from haematological malignancies. To enhance comparability of study data, development and implementation of core sets of measuring devices would be helpful

Whole-Body Vibration Training Designed to Improve Functional Impairments After Pediatric Inpatient Anticancer Therapy: A Pilot Study

Purpose: To assess a whole-body vibration (WBV) intervention for children after cancer treatment. Methods: Eleven children after inpatient anticancer therapy participated in a 12-week supervised WBV intervention, which consisted of one 9- to 13-minute WBV session per week, with 5 to 9 minutes' overall vibration time. Feasibility was defined as the ability to participate in WBV training without reporting adverse events. The number of offered and completed training sessions, program acceptance, and measures of function were assessed. Results: Nine participants completed the WBV intervention without any WBV-related adverse events. The adherence rate was 87.96%. Only minor side effects were reported and there was general program acceptance. We found indications that WBV has positive effects on knee extensor strength and active ankle dorsiflexion range of motion. Conclusions: WBV was feasible, safe, and well received among children after inpatient anticancer therapy. No health deteriorations were observed. Positive effects need to be confirmed in future trials

Sensorimotor Training in Paediatric Oncology: Implementation of a Child-Friendly and Playful Training Concept

In sensorimotor training (SMT), in this case balance training as a sub-category of SMT, exercises are carried out on different surfaces and in different standing positions. SMT has the potential to induce regenerative and adaptive mechanisms, contributing to the plasticity of the nervous system. While the effort and material involved for this exercise modality is minimal, effects remain high and reproducibility is good. It can be adjusted individually to the participant's daily performance level. To date, SMT has been conducted in the context of rehabilitation as well as injury and fall prevention. In recent years, SMT has also been successfully implemented in adult oncology in order to improve common impairments of the lower extremities, such as reduced balance control. Children after inpatient oncological treatment also suffer from various mobility-related impairments of their lower extremities which can lead to further physical inactivity. These impairments may occur as a result of chemotherapy induced peripheral neuropathy (CIPN). SMT seems to have the potential to improve sensory and motor dysfunctions, contributing to higher physical activity in general. With the objective of implementing a child-friendly, motivating and individual SMT, a specific training concept for paediatric oncology was developed at the Department of Sport, Exercise and Health at the University of Basel. In this training concept, children use a turntable to compose the sensorimotor exercises based on their daily performance level. The feasibility of the training concept was tested in a 4-week pilot study, conducted within an established exercise program after cancer treatment of the German Sport University Cologne in the Children's Hospital Amsterdamer Strasse Cologne. 6 children and adolescents after oncological treatment took part. The preliminary results of the pilot study and a case example show that a child-friendly and playful SMT after paediatric oncological disease is feasible without occurrence of adverse events. Therefore, SMT might be a valuable and targeted training modality supplementing exercise therapy in paediatric oncology

Whole-body vibration training for inpatient children and adolescents receiving chemotherapy for first cancer diagnosis: an exploratory feasibility study

Whole-body vibration (WBV) is a feasible and potentially beneficial exercise strategy for managing neuromuscular impairments like decreased strength or flexibility, mobility limitations and bone health in pediatric cancer survivors. However, as starting rehabilitation as early as possible is recommended to preserve physical function, this study investigated the feasibility of WBV for patients receiving cancer treatment for first cancer diagnosis. Eleven patients (various types of cancer, ages 7-17) participated in the supervised WBV intervention concomitant to acute cancer treatment, which involved chemotherapy. Training was implemented as part of a general exercise program and offered 3 days per week during hospitalization (warm-up, four progressive training exercises comprising 60-120 s, 21-27 Hz, 2 mm peak-to-peak-displacement). Feasibility, which was defined as the absence of WBV-related serious adverse events leading to study dropout, was primarily evaluated. Training documentation was additionally analyzed. As a main result, no serious adverse events leading to study dropout were reported. However, two incidents of bleeding (adverse events) were observed in patients with bleeding tendencies and low platelets (thrombocytes < 30,000/mu L). After adjusting the platelet count threshold for WBV participation to 30,000/mu L, no further incidents occurred. Moreover, due to WBV-related side effects like physical exhaustion, 11% of all training sessions had to be stopped and another 11% required reductions in the vibration load. Patients participated in 48% of the planned sessions. While main reasons for non-attendance were medical issues (35%), only few WBV sessions were missed, not completed or needed modifications due to motivational issues. Consequently, WBV seems to be feasible for inpatient pediatric patients receiving chemotherapy for first cancer diagnosis, given a sufficiently high platelet count of at least 30,000/mu L. Although WBV tolerance and training motivation appear high, patient's reduced medical condition during hospitalization can negatively impact training progression and attendance. Future research is required to confirm our findings on feasibility and to assess efficiency of WBV training for pediatric cancer patients receiving cancer treatment

Aerobic physical exercise for adult patients with haematological malignancies

Background Although people with haematological malignancies have to endure long phases of therapy and immobility which is known to diminish their physical performance level, the advice to rest and avoid intensive exercises is still common practice. This recommendation is partly due to the severe anaemia and thrombocytopenia from which many patients suffer. The inability to perform activities of daily living restricts them, diminishes their quality of life and can influence medical therapy. Objectives To evaluate the efficacy, safety and feasibility of aerobic physical exercise for adults suffering from haematological malignancies. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2014, Issue 1) and MEDLINE (1950 to January 2014) as well as conference proceedings for randomised controlled trials (RCTs). Selection criteria We included RCTs comparing an aerobic physical exercise intervention, intending to improve the oxygen system, in addition to standard care with standard care only for adults suffering from haematological malignancies. We also included studies that evaluated aerobic exercise in addition to strength training. We excluded studies that investigated the effect of training programmes that were composed of yoga, tai chi chuan, qigong or similar types of exercise. We also excluded studies exploring the influence of strength training without additive aerobic exercise. Additionally, we excluded studies assessing outcomes without any clinical impact. Data collection and analysis Two review authors independently screened search results, extracted data and assessed the quality of trials. We used risk ratios (RRs) for adverse events and 100-day survival, standardised mean differences for quality of life (QoL), fatigue, and physical performance, and mean differences for anthropometric measurements. Main results Our search strategies identified 1518 potentially relevant references. Of these, we included nine RCTs involving 818 participants. The potential risk of bias in these trials is unclear, due to poor reporting. The majority of participants suffered fromacute lymphoblastic leukaemia (ALL), acutemyeloid leukaemia (AML), malignant lymphoma and multiple myeloma, and six trials randomised people receiving stem cell transplantation. Mostly, the exercise intervention consisted of various walking intervention programmes with different duration and intensity levels. Our primary endpoint of overall survival (OS) was not analysed in any of the included trials, but three trials reported deceased participants during the course of the study or during the first 100 days. There is no evidence for a difference between participants exercising and those in the control group (RR 0.93; 95% CI 0.59 to 1.47; P = 0.75; 3 trials, 269 participants, moderate quality of evidence). Four trials analysed the influence of exercise intervention on quality of life (QoL). Excluding one trial with serious baseline imbalances, physical exercise improves QoL (SMD 0.26; 95% CI 0.03 to 0.49; P = 0.03; 3 trials, 291 participants, low quality of evidence). This positive effect of exercise was also found in the subscales physical functioning (SMD 0.33; 95% CI 0.13 to 0.52; P = 0.0009; 4 trials, 422 participants, moderate quality of evidence) and depression (SMD 0.25; 95% CI -0.00 to 0.50; P = 0.05; 3 trials, 249 participants, low quality of evidence). However, there is no evidence for a difference between additional exercise and standard treatment for the subscale anxiety (SMD -0.18; 95% CI -0.64 to 0.28; P = 0.45; 3 trials, 249 participants, low quality of evidence). Seven trials (692 participants) evaluated fatigue. There is moderate quality of evidence that exercise improves fatigue (SMD 0.24; 95% CI 0.08 to 0.40; P = 0.003). Eight studies evaluated various aspects of physical performance (e. g. aerobic capacity, cardiovascular fitness), but none of them could be pooled in a meta-analysis. In seven trials there is a tendency or statistically significant effect favouring the exercise group (very low quality of evidence). Three trials (266 participants) investigated serious adverse events (SAEs) (e. g. bleeding, fever, pneumonia, deep vein thrombosis, and infection), and one trial (122 participants) assessed adverse events (AEs). There is no evidence for a difference between arms in terms of SAEs (RR 1.44; 95% CI 0.96 to 2.18; P = 0.06) or AEs (RR 7.23; 95% CI 0.38 to 137.05; P = 0.19); both findings are based on low quality of evidence. Authors' conclusions There is no evidence for differences in mortality between the exercise and control groups. Physical exercise added to standard care can improve quality of life, especially physical functioning, depression and fatigue. Currently, there is inconclusive evidence regarding anxiety, physical performance, serious adverse events and adverse events. We need further trials with more participants and longer follow-up periods to evaluate the effects of exercise intervention for people suffering from haematological malignancies. Furthermore, we need trials with overall survival as the primary outcome to determine whether the suggested benefits will translate into a survival advantage. To enhance comparability of study data, development and implementation of core sets of measuring devices would be helpful