Effect of combined therapies including nutrition and physical exercise in advanced cancer patients: A pooled analysis.

Background and aims: Although many cancer patients suffer from malnutrition or cancer cachexia, there is no standard of care so far due to limited intervention trials. Pooled data from two combined trials were analyzed regarding nutritional status and survival time. Materials and methods: Data from two trials with advanced cancer patients were included. In both trials, patients in the intervention group received at least three times nutritional counseling and supervised training sessions. Patients in the control group continued being treated according to usual care. Nutritional status was measured using BMI, body composition and handgrip strength. Survival time was analyzed using the Cox proportional hazard model with the period between the beginning of the trial and death as underlying time scale. Results: 68 men (61.8%) and 42 women (38.2%) were randomized either to the intervention (n = 56) or the control (n = 54) group. The inter-group difference for changes in BMI and body composition was not statistically significant after 3 months. Handgrip strength improved significantly from 34.4 ± 10.2 kg to 36.3 ± 9.9 kg at 3 months in the intervention compared to 33.9 ± 9.2 kg to 34.9 ± 9.1 kg in the control group (p = 0.006). The analysis of survival time showed no inter-group difference for all patients. A detailed analysis for different diagnoses showed that in patients with lung cancer, the covariates "CRP value," "days from first diagnosis to randomization" as well as "gender" were significantly associated with survival time. Patients with higher CRP value had a shorter survival time and female patients had a shorter survival time than male patients in our analysis. In addition, patients with pancreatic cancer randomized to the control group had a 20% shorter survival time than those in the intervention group (p = 0.048). Conclusion: The pooled analysis showed a significant improvement of handgrip strength in advanced cancer patients through the implementation of a combined therapy. Handgrip strength is of prognostic significance in hospitalized patients due to its association with mortality and morbidity. However, no improvements in further tests were detected. There is great need for further investigations examining the effect of nutritional and exercise therapy on survival time with focus on different cancer diagnoses.

Are psychosocial variables, sleep characteristics or central pain processing prognostic factors for outcome following rotator cuff repair? A protocol for a prospective longitudinal cohort study.

INTRODUCTION: Prognosis following surgical rotator cuff repair (RCR) is often established through the assessment of non-modifiable biomedical factors such as tear size. This understates the complex nature of recovery following RCR. There is a need to identify modifiable psychosocial and sleep-related variables, and to find out whether changes in central pain processing influence prognosis after RCR. This will improve our knowledge on how to optimise recovery, using a holistic rehabilitation approach. METHODS AND ANALYSIS: This longitudinal study will analyse 141 participants undergoing usual care for first time RCR. Data will be collected 1-21 days preoperatively (T1), then 11-14 weeks (T2) and 12-14 months (T3) postoperatively. We will use mixed-effects linear regression to assess relationships between potential prognostic factors and our primary and secondary outcome measures-the Western Ontario Rotator Cuff Index; the Constant-Murley Score; the Subjective Shoulder Value; Maximal Pain (Numeric Rating Scale); and Quality of Life (European Quality of Life, 5 dimensions, 5 levels). Potential prognostic factors include: four psychosocial variables; pain catastrophising, perceived stress, injury perceptions and patients' expectations for RCR; sleep; and four factors related to central pain processing (central sensitisation inventory, temporal summation, cold hyperalgesia and pressure pain threshold). Intercorrelations will be assessed to determine the strength of relationships between all potential prognostic indicators.Our aim is to explore whether modifiable psychosocial factors, sleep-related variables and altered central pain processing are associated with outcomes pre-RCR and post-RCR and to identify them as potential prognostic factors. ETHICS AND DISSEMINATION: The results of the study will be disseminated at conferences such as the European Pain Congress. One or more manuscripts will be published in a peer-reviewed SCI-ranked journal. Findings will be reported in accordance with the STROBE statement and PROGRESS framework. Ethical approval is granted by the Ethical commission of Canton of Zurich, Switzerland, No: ID_2018-02089 TRIAL REGISTRATION NUMBER: NCT04946149.

Prehabilitation in patients undergoing colorectal surgery fails to confer reduction in overall morbidity: results of a single-center, blinded, randomized controlled trial.

BACKGROUND: Currently, there are solely weak recommendations in the enhanced recovery after surgery (ERAS) protocol regarding the role of preoperative physical activity and prehabilitation in patients undergoing colorectal surgery. Studies in heterogenous groups showed contradictory results regarding the impact of prehabilitation on the reduction of postoperative complications. The aim of this study was to assess the impact of prehabilitation on postoperative complications in patients undergoing colorectal surgery within an ERAS protocol. METHODS: Between July 2016 and June 2019, a single-center, blinded, randomized controlled trial designed to test whether physiotherapeutic prehabilitation vs. normal physical activities prior to colorectal surgery may decrease morbidity within a stringent ERAS protocol was carried out. The primary endpoint was postoperative complications assessed by Comprehensive Complications Index (CCI®). Primary and secondary endpoints for both groups were analyzed and compared. RESULTS: A total of 107 patients (54 in the prehabilitation enhanced recovery after colorectal surgery [pERACS] group and 53 in the control group) were included in the study and randomized. Dropout rate was 4.5% (n = 5). Baseline characteristics were comparable between the pERACS and control groups. The percentage of colorectal adenocarcinoma was low in both groups (pERACS 32% vs. control 23%, p = 0.384). Almost all patients underwent minimally invasive surgery in both groups (96% vs. 98%, p = 1.000). There was no between-group difference in the primary outcome, as the mean CCI at 30-day postoperative in the pERACS group was 18 (SD 0-43) compared to 15 (SD 0-49) in the control group (p = 0.059). Secondary outcome as complications assessed according to Clavien-Dindo, length of hospital stay, reoperation rate, and mortality showed no difference between both groups. CONCLUSIONS: Routine physiotherapeutic prehabilitation has no additional benefit for patients undergoing colorectal surgery within an ERAS protocol. TRIAL REGISTRATION: ClinicalTrial.gov: ID: NCT02746731; Institution Ethical Board Approval: KEK-ZH Nr. 2016-00,229.

One year follow-up of physical performance and quality of life in patients surviving COVID-19: a prospective cohort study.

INTRODUCTION: The coronavirus disease (COVID-19) continues to affect many countries globally, with the long-term impact of the disease now being recognized. According to the latest research, some of the affected individuals continue to experience functional limitations, reduced physical performance and impaired health-related quality of life (HRQoL) even after eight months. This prospective cohort study aimed to describe the longer-term recovery of physical performance and HRQoL in COVID-19 survivors over one year. METHOD: A cohort (n = 43; 32-84 years old) hospitalized with COVID-19 between March and June 2020 was followed over one year and assessed at three time points: hospital discharge, 3 months and 12 months post-admission. Participants experienced mild (10/43) to critical (6/43) pneumonia and stayed in the hospital for a median of 10 days (IQR 9). Participants were assessed for physical performance (six-minute walk test), HRQoL (EQ-5D-5L), COVID-19 related limitations in functionality (PCFS), hospital-related anxiety and depression (HADS-A/-D), lung function (FEV1, FVC) and dyspnea during activity (mMRC). All assessments were conducted by physiotherapists trained in cardio-respiratory rehabilitation. RESULTS: After discharge, 8/34 showed reduced physical performance, 9/42 had lower HRQoL and 14/32 had COVID-19 induced limitations in functionality on the PCFS scale. Physical performance did not change significantly between discharge and 12-month follow-up, but 15/34 participants showed clinically relevant improvements in walking distance (>30 m). However, 16/34 had a decreased walking distance >30 m when comparing 3-month to 12-month follow-up. At 12 months, 12/41 of participants still perceived COVID-19 related limitations in daily life on the PCFS scale. For HRQoL, 12/41 participants still perceived moderate-to-severe symptoms of pain and discomfort and 13/41 slight-to-severe symptoms of anxiety and depression. CONCLUSION: This cohort of adult patients hospitalized for mild to severe COVID-19 in Switzerland was generally mildly affected but still reported some limitations after one year. These results offer preliminary indications for ongoing support after hospitalization and point towards the need for specific, individualized follow-up to support their recovery.

Effect of counselling during pulmonary rehabilitation on self-determined motivation to be physically active for people with chronic obstructive pulmonary disease: a pragmatic RCT.

BACKGROUND: Counselling is considered to be a promising approach to increasing physical activity (PA) in people with chronic obstructive pulmonary disease (COPD). The aim of the current study was to investigate whether a PA counselling program for people with COPD, when embedded in a comprehensive outpatient pulmonary rehabilitation (PR) program, increased their daily PA. METHODS: A two-armed, single blind randomized controlled trial was conducted as a component of a 12-week outpatient pulmonary rehabilitation program. The participants randomized into the intervention group received five counselling sessions, based on the principles of motivational interviewing (MI), with a physiotherapist. The participants' steps per day and other proxies of PA were measured using an accelerometer (SenseWear Pro®) at baseline, at the end of the PR program, and three months later. The group-by-time interaction effect was analyzed. RESULTS: Of the 43 participants,17 were allocated to the intervention group and 26 to the usual-care control group (mean age 67.9 ± 7.9; 21 (49%) males; mean FEV1 predicted 47.1 ± 18.6). No difference between groups was found for any measure of PA at any point in time. CONCLUSIONS: In this study, counselling, based on MI, when embedded in a comprehensive PR program for people with COPD, showed no short-term or long-term effects on PA behavior. To investigate this potentially effective counselling intervention and to analyze the best method, timing and tailoring of an intervention embedded in a comprehensive outpatient PR program, further adequately powered research is needed. TRIAL REGISTRATION: Clinical Trials.gov NCT02455206 (05/21/2015), Swiss National Trails Portal SNCTP000001426 (05/21/2015).

The Influence of Pulmonary Rehabilitation and Counselling on Perceptions of Physical Activity in Individuals with COPD - A Qualitative Study.

Objective: The aim of this study was to explore to what extent a combined counselling and pulmonary rehabilitation program (PR) influences the perception of physical activity (PA) and motivation for behavioral change in PA in individuals with COPD. The results of previous quantitative trial that investigated the effect of this combined treatment on daily PA were inconclusive. It is conjectured that a more targeted tailoring of the counselling and PR intervention could improve its effectiveness. Patients and Methods: Eighteen individuals with COPD (median age 69, 8 females) who had participated in the PneumoReha program were interviewed twice (following PR and at three-month follow-up). These interviews were transcribed and analyzed thematically. Based on the codes thus identified, three categories 'perception of PA intensity', 'quality of motivation to perform PA', and 'strategies to cope with barriers' were used to differentiate 'types' of participants. Results: Four different types of COPD individuals were distinguished. Study findings indicate that those individuals who participated in the PR program combined with embedded counselling tended to be more active and intrinsically motivated. Conclusion: A typology of four types of people with COPD was developed, characterized by their perception of activity, individual motivation and strategies for managing barriers. The patients' physical activity level might be influenced by their concept of physical activity and the quality of motivation. Recognizing patients' different activity behaviors is important for improving the quality of outpatient PR programs and developing tailored (according to each type) counselling interventions embedded in outpatient PR programs. Clinical Trial Registration: The study was registered on the website of https://www.clinicaltrials.gov/ with the identifier NCT02455206 (27/05/2015), as well as on the Swiss National Trails Portal SNCTP000001426 (05/21/2015).

Influence of weekday of admission and level of distress on length of hospital stay in patients with low back pain: a retrospective cohort study.

BACKGROUND: Low back pain (LBP) is often a complex problem requiring interdisciplinary management to address patients' multidimensional needs. Providing inpatient care for patients with LBP in primary care hospitals is a challenge. In this setting, interdisciplinary LBP management is often unavailable during weekends. Delays in therapeutic procedures may result in a prolonged length of hospital stay (LoS). The impact of delays on LoS might be strongest in patients reporting high levels of psychological distress. Therefore, this study investigates the influence of weekday of admission and distress on LoS of inpatients with LBP. METHODS: This retrospective cohort study was conducted between 1 February 2019 and 31 January 2020. In part 1, a negative binomial model was fitted to LoS with weekday of admission as a predictor. In part 2, the same model included weekday of admission, distress level, and their interaction as covariates. Planned contrast was used in part 1 to estimate the difference in log-expected LoS between group 1 (admissions Friday/Saturday) and the reference group (admissions Sunday-Thursday). In part 2, the same contrast was used to estimate the corresponding difference in (per-unit) distress trends. RESULTS: We identified 173 patients with LBP. The mean LoS was 7.8 days (SD = 5.59). Patients admitted on Friday (mean LoS = 10.3) and Saturday (LoS = 10.6) had longer stays, but not those admitted on Sunday (LoS = 7.1). Analysis of the weekday effect and planned contrast showed that admission on Friday or Saturday was associated with a significant increase in LoS (log ratio = 0.42, 95% CI = 0.21 to 0.63). A total of 101 patients (58%) returned questionnaires, and complete data on distress were available from 86 patients (49%). According to the negative binomial model for LoS and the planned contrast, the distress effect on LoS was significantly influenced (difference in slopes = 0.816, 95% CI = 0.03 to 1.60) by dichotomic weekdays of admission (Friday/Saturday vs. Sunday-Thursday). CONCLUSIONS: Delays in interdisciplinary LBP management over the weekend may prolong LoS. This may particularly affect patients reporting high levels of distress. Our study provides a platform to further explore whether interdisciplinary LBP management addressing patients' multidimensional needs reduces LoS in primary care hospitals.

Feasibility of an Outpatient Training Program after COVID-19.

Long-term physical consequences of coronavirus disease 2019 (COVID-19) are currently being reported. As a result, the focus is turning towards interventions that support recovery after hospitalization. To date, the feasibility of an outpatient program for people recovering from COVID-19 has not been investigated. This study presents data for a physiotherapy-led, comprehensive outpatient pulmonary rehabilitation (PR) program. Patients were recruited after hospital discharge. Training consisted of twice weekly, interval-based aerobic cycle endurance (ACE) training, followed by resistance training (RT); 60-90 min per session at intensities of 50% peak work rate; education and physical activity coaching were also provided. Feasibility outcomes included: recruitment and dropout rates, number of training sessions undertaken, and tolerability for dose and training mode. Of the 65 patients discharged home during the study period, 12 were successfully enrolled onto the program. Three dropouts (25%) were reported after 11-19 sessions. Tolerability of interval-based training was 83% and 100% for exercise duration of ACE and RT, respectively; 92% for training intensity, 83% progressive increase of intensity, and 83% mode in ACE. We tentatively suggest from these preliminary findings that the PR protocol used may be both feasible, and confer benefits to a small subgroup of patients recovering from COVID-19.

Effect of a leucine-rich supplement in combination with nutrition and physical exercise in advanced cancer patients: A randomized controlled intervention trial.

BACKGROUND & AIMS: Branched-chain amino acids and specifically leucine stimulate protein synthesis and may overcome an anabolic resistance in malnourished and cachectic cancer patients. Therefore, we hypothesized that the addition of a leucine-rich supplement to a multimodal therapy improves physical function in advanced cancer patients. METHODS: This single center, randomized trial examined a multimodal therapy over 12 weeks in patients with advanced cancer. The intervention group received a leucine-rich supplement in combination with a nutrition and physical exercise program. Patients in the control group received standard care. Primary endpoint was physical function measured with the short physical performance battery (SPPB). Secondary endpoints were further physical performance tests, nutritional status, dietary intake, fatigue, quality of life (QoL) and clinical course. All parameters were evaluated at baseline, after three and at six months. RESULTS: 23 women and 29 men with an average age of 63.1 ± 10.3 (range 30-81) years and BMI of 25.4 ± 4.7 kg/m2 were randomized either to the intervention (n = 27) or control (n = 25) group. Patients in the intervention group joined a mean of 28.4 ± 7.4 training sessions (78.8%), 3.2 ± 0.6 nutritional counselling sessions (106.7%) and consumed on average 85.4 ± 33.2 supplements (71.2%). Inter-group comparison showed no significant difference in the primary endpoint SPPB after three (p = 0.184, 95% CI: -1.43, 0.29) and six months (p = 0.986, 95% CI: -0.87, 0.89). However, the secondary endpoint handgrip strength improved significantly from 35.8 ± 9.8 kg at baseline to 37.6 ± 10.0 kg at three months in the intervention group compared to 35.7 ± 8.8 kg at baseline to 34.0 ± 10.1 kg at three months in the control group (p < 0.001, 95% CI: -6.03, -1.97). The inter-group difference for changes in the further secondary endpoints nutritional status, dietary intake, fatigue, QoL and clinical course showed a trend towards an improvement in the intervention group, however, the differences were not significant after three and six months. CONCLUSIONS: The present trial demonstrated a good adherence to the multimodal therapy as well as a significant improvement of handgrip strength in patients with advanced cancer. In addition, the clinical course data underlined the safety of the program. However, we failed to show significant improvements in further physical performance tests, especially our primary outcome factor SPPB as well as nutritional status, fatigue or QoL.

Effects of nutrition and physical exercise intervention in palliative cancer patients: A randomized controlled trial.

BACKGROUND & AIMS: Cancer cachexia is multifactorial and should be targeted using a multimodal form of intervention. The purpose of the present trial was to test the effects of a combined nutrition and physical exercise program on cancer patients with metastatic or locally advanced tumors of the gastrointestinal and lung tracts. METHODS: Patients were randomized into two groups: One group received a minimum of three standardized individual nutritional counselling sessions and participated in a 60-min exercise program twice a week. The second group received their usual care. The intervention spanned a period of three months. Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0), physical performance (hand-grip strength, 6-min walk test, timed sit-to-stand test and 1 repetition maximum leg press), nutritional status (body weight, bioelectrical impedance analysis), dietary intake (three-day dietary record) and clinical data (unexpected hospital days, performance status) were tested at baseline and after three and six months. RESULTS: In total, 18 women and 40 men (mean age 63, range 32-81) with metastatic or locally advanced tumors of the gastrointestinal (n = 38) and lung (n = 20) tracts were included. Median adherence to the supervised exercise program was 75%. The median number of individual nutritional counselling sessions was 3.0 (range 0-7 sessions). Post intervention, no difference in global health status/quality of life (overall QoL) was observed. Intervention was superior to UC for the patient-rated symptom scale regarding nausea and vomiting (p = 0.023) and protein intake (p = 0.01). No statistical differences were observed for energy intake, nutritional status and physical performance. CONCLUSIONS: The results show good adherence to a combined nutrition and exercise program. The multimodal intervention did not improve overall QoL, but contributed to an adequate protein intake and to the general well-being of the patient by reducing nausea and vomiting.

Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial.

BACKGROUND: A key element in the postoperative phase of the standardized Enhanced Recovery After Surgery (ERAS) treatment pathways is mobilization. Currently, there are no recommendations in the ERAS guidelines for preoperative physical activity. Patients undergoing major surgery are prone to functional decline due to the impairment of muscle, cardiorespiratory, and neurological function as a response to surgical stress. It has been shown that preoperative physical training reduces postoperative complications. To date, there are limited studies that investigate preoperative physical training combined with ERAS. OBJECTIVE: The aim of this study is to assess the impact of tailored physical training prior to colorectal surgery conducted according to an ERAS protocol on overall morbidity. This study proposes the initial hypothesis that 3-6 weeks of prehabilitation before elective colorectal surgery may improve postoperative outcome and reduce complication rates, assessed using the Comprehensive Complication Index. The primary objective is to evaluate overall morbidity due to postoperative complications. Additionally, complications are assessed according to the Clavien-Dindo classification, length of stay, readmission rate, mortality rate, and treatment-related costs. METHODS: The prehabilitation Enhanced Recovery After colorectal Surgery (pERACS) study is a single-center, single-blinded prospective randomized controlled trial. Patients scheduled for colorectal resections are randomly assigned either to the prehabilitation group or the control group. All patients are treated with the ERAS pathway for colorectal resections according to a standardized study schedule. Sample size calculation performed by estimating a clinically relevant 25% reduction of postoperative complications (alpha=.05, power 80%, dropout rate of 10%) resulted in 56 randomized patients per group. RESULTS: Following ethical approval of the study protocol, the first patient was included in June 2016. At this time, a total of 40 patients have been included; 27 patients terminated the study by the end of March 2017. Results are expected to be published in 2018. CONCLUSIONS: The pERACS trial is a single-center, single-blinded prospective randomized controlled trial to assess the impact of tailored physical training prior to colorectal surgery, conducted according to an ERAS protocol, in order to evaluate overall morbidity. TRIAL REGISTRATION: Clinicaltrials.gov NCT02746731; https://clinicaltrials.gov/ct2/show/NCT02746731 (Archived by WebCite at http://www.webcitation.org/6tzblGwge).

Effect of counselling during pulmonary rehabilitation on self-determined motivation towards physical activity in people with chronic obstructive pulmonary disease - protocol of a mixed methods study.

BACKGROUND: Physical activity promotion in people with Chronic Obstructive Pulmonary Disease (COPD) is focus of research and public health. Patient-centred interventions like counselling are promising approaches to help patients reducing sedentary behaviour. Aim of the present study is to investigate if a physical activity counselling program during pulmonary rehabilitation increases physical activity level in daily life in people with COPD. METHODS: A two-armed, single blind randomised controlled trial including 56 people with COPD will be conducted in an outpatient pulmonary rehabilitation. Patients will participate in a 12-week-rehabilitation program; individuals randomized to the interventional group will additionally participate in five counselling sessions with a physiotherapist, based on the principles of motivational interviewing. The participants' physical activity level will be measured using an accelerometer (SenseWear Pro®) before, directly and 3 months after pulmonary rehabilitation. Semi-structured interviews will be conducted to learn more about barriers and facilitators regarding daily physical activity. DISCUSSION: If the strategy successfully improves the physical activity level in people with COPD, counselling might be implemented in pulmonary rehabilitation. TRIAL REGISTRATION: Clinical Trials.gov NCT02455206 (05/21/2015), Swiss National Trails Portal SNCTP000001426 (05/21/2015).