One year of Football Fitness improves L1-L4 BMD, postural balance, and muscle strength in women treated for breast cancer.

PURPOSE: To examine efficacy of 12 months Football Fitness offered twice per week on bone mineral density (BMD), bone turnover markers (BTM), postural balance, muscle strength, and body composition in women treated for early-stage breast cancer (BC). METHODS: Women treated for early-stage BC were randomized to Football Fitness (FFG, n = 46) or control (CON, n = 22) in a 2:1 ratio for 12 months, with assessments performed at baseline, 6 months and 12 months. Outcomes were total body-, lumbar spine- and proximal femur BMD, total body lean and fat mass, leg muscle strength, postural balance, and plasma amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin, and C-terminal telopeptide of type 1 collagen (CTX). Intention-to-treat (ITT) analyses and per-protocol analyses (≥50% attendance in FFG) were performed using linear mixed models. RESULTS: Participants in FFG completing the 12-month intervention (n = 33) attended 0.8 (SD = 0.4) sessions per week. Intention to treat analysis of mean changes over 12 months showed significant differences (p<.05) in L1-L4 BMD (0.029 g/cm2 , 95%CI: 0.001 to 0.057), leg press strength (7.2 kg, 95%CI: 0.1 to 14.3), and postural balance (-4.3 n need of support, 95%CI: -8.0 to -0.7) favoring FFG compared to CON. In the per-protocol analyses, L1-L4 and trochanter major BMD were improved (p = .012 and .030, respectively) in FFG compared with CON. No differences were observed between groups in BTMs in the ITT or per protocol analyses. CONCLUSION: One year of Football Fitness training may improve L1-L4 BMD, leg muscle strength, and postural balance in women treated for early-stage breast cancer.

Effects of football fitness training on lymphedema and upper-extremity function in women after treatment for breast cancer: a randomized trial.

BACKGROUND: Breast cancer survivors are encouraged to be physically active. A recent review suggests that football training is an effective exercise modality for women across the lifespan, positively influencing health variables such as strength, fitness and social well-being. However, football is a contact sport, potentially posing an increased risk of trauma-related injury. Against this backdrop, breast cancer survivors are advised to avoid trauma or injury to the affected or at-risk arm in order to protect against lymphedema onset or exacerbation. The aim of this study was therefore to evaluate the feasibility and safety of Football Fitness training in relation to lymphedema and upper-extremity function after treatment for breast cancer. MATERIAL AND METHODS: Sixty-eight women aged 18-75 years, who had received surgery for stage I-III breast cancer and completed (neo) adjuvant chemotherapy and/or radiotherapy within five years, were randomized (2:1) to a Football Fitness group (FFG, n = 46) or a control group (CON, n = 22) for twelve months. Secondary analyses using linear mixed models were performed to assess changes in upper-body morbidity, specifically arm lymphedema (inter-arm volume % difference, dual energy X-ray absorptiometry; extracellular fluid (L-Dex), bioimpedance spectroscopy), self-reported breast and arm symptoms (EORTC breast cancer-specific questionnaire (BR23) and upper-extremity function (DASH questionnaire) at baseline, six- and twelve-month follow-up. RESULTS: We observed similar point prevalent cases of lymphedema between groups at all time points, irrespective of measurement method. At the six-month post-baseline assessment, reductions in L-Dex (extracellular fluid) were found in FFG versus CON. These significant findings were not maintained at the twelve-month assessment. No difference between groups was observed for inter-limb volume difference %, nor any of the remaining outcomes. CONCLUSION: While superiority of Football Fitness was not observed, the results support that participation in Football Fitness training is feasible and suggests no negative effects on breast cancer-specific upper-body morbidity, including lymphedema. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov. NCT03284567.

Exercise intensity and cardiovascular health outcomes after 12 months of football fitness training in women treated for stage I-III breast cancer: Results from the football fitness After Breast Cancer (ABC) randomized controlled trial.

PURPOSE: To examine the exercise intensity and impact of 12 months of twice-weekly recreational football training on cardiorespiratory fitness (CRF), blood pressure (BP), resting heart rate (HRrest), body fat mass, blood lipids, inflammation, and health-related quality of life in women treated for early-stage breast cancer (BC). METHODS: Sixty-eight women who had received surgery for stage I-III BC and completed adjuvant chemo- and/or radiation therapy within 5 years were randomized in a 2:1 ratio to a Football Fitness group (FFG, n = 46) or a control group (CON, n = 22). Football Fitness sessions comprised a warm-up, drills and 3-4 × 7 min of small-sided games (SSG). Assessments were performed at baseline, 6 months and 12 months. Outcomes were peak oxygen uptake (VO2peak), blood pressure (BP), HRrest, total body fat mass, and circulating plasma lipids and hs-CRP, and the 36-Item Short Form Health Survey (SF36). Intention-to-treat (ITT) analyses were performed using linear mixed models. Data are means with SD or 95% confidence intervals. RESULTS: Adherence to training in participants completing the 12-months follow-up (n = 33) was 47.1% (22.7), and HR during SSG was ≥80% of HRmax for 69.8% (26.5) of total playing time. At baseline, VO2peak was 28.5 (6.4) and 25.6 (5.9) ml O2/kg/min in FFG and CON, respectively, and no significant changes were observed at 6- or 12 months follow-up. Systolic BP (SBP) was 117.1 (16.4) and 116.9 (14.8) mmHg, and diastolic BP (DBP) was 72.0 (11.2) and 72.4 (8.5) mmHg in FFG and CON, respectively, at baseline, and a 9.4 mmHg decrease in SBP in CON at 12 months resulted in a between-group difference at 12 months of 8.7 mmHg (p = .012). Blood lipids and hs-CRP were within the normal range at baseline, and there were no differences in changes between groups over the 12 months. Similarly, no differences between groups were observed in HRrest and body fat mass at 6- and12-months follow-up. A between-group difference in mean changes of 23.5 (0.95-46.11) points in the role-physical domain of the SF36 survey favored FFG at 6 months. CONCLUSION: Football Fitness training is an intense exercise form for women treated for breast cancer, and self-perceived health-related limitations on daily activities were improved after 6 months. However, 1 year of Football Fitness training comprising 1 weekly training session on average did not improve CRF, BP, blood lipids, fat mass, or HRrest. TRIAL REGISTRATION NUMBER: The trial was registered at ClinicalTrials.gov with identifier NCT03284567.

Is specialized palliative cancer care associated with use of antineoplastic treatment at the end of life? A population-based cohort study.

BACKGROUND: The use of chemotherapy in the last 14 days of life should be as low as possible. AIM: To study the factors related to the use of chemotherapy in the last 14 days of life and the factors related to concurrent antineoplastic treatment and specialized palliative care. DESIGN: This was a population-based cohort study. The data were collected from the Danish Register of Causes of Death, the Danish National Patient Register, and the Danish Palliative Care Database. Analyses were descriptive and multivariate logistic regression. SETTING/PARTICIPANTS: Cancer decedents between 2010 and 2013 in the Capital Region of Denmark. RESULTS: During the study period, 17,246 individuals died of cancer and 33% received specialized palliative care. In the last 14 days of life, 4.2% received chemotherapy. Younger patients and patients with hematological cancers were more likely to receive chemotherapy in the last 14 days of life. Receiving specialized palliative care was associated with a lower risk of receiving chemotherapy in the last 14 days of life-odds ratio 0.15 for hospices and 0.53 for palliative hospital units. A total of 8% of the population received concurrent antineoplastic treatment and specialized palliative care. Female gender, younger age, and breast and prostate cancer were significantly associated with this concurrent model. CONCLUSION: Overall, the incidence of antineoplastic treatment in the last 14 days of life was low compared to other studies. Patients in specialized palliative care had a reduced risk of receiving chemotherapy at the end of life.

[Ten recommendations for cancer survivors supporting health improvement and secondary prevention].

An increasing number of individuals diagnosed with cancer survive and die of a new cancer or other lifestyle-related diseases. With the intent to encourage and assist oncologists in promoting lifestyle changes to improve health of their patients, this article sums up the evidence behind a brochure including ten one-line health messages in Danish inspired by the American initiative Cancer Survivors' Eight Ways to Stay Healthy After Cancer. We conclude by discussing the challenges of implementation of preventive and health promoting activities in clinical practice in Denmark.

Home-based specialized palliative care in patients with advanced cancer: A systematic review.

OBJECTIVE: Due to an urgent need for specialized palliative care (SPC) for patients with advanced cancer, an overview of available information on organization and outcomes of home-based SPC would be valuable. Our systematic review aims to give an overview of available information on the organization and outcomes of home-based SPC for patients with advanced cancer. Outcomes related to place of death, survival time, quality of life, performance status, and symptom management are included. METHOD: A PICO process search strategy consisting of terms related to cancer, palliation, and home care was employed. The search was conducted in PubMed, EMBASE, and Cochrane from January 1, 2000, to January 27, 2015. A hand search of the reference lists of the included studies was also performed. RESULTS: A total of 5 articles (out of 2080 abstracts) were selected for analysis. Three additional studies were added by the hand search. Six observational and two interventional studies were evaluated. In all of these studies, the description of the SPC service was limited to the composition of the staff-no other organizational aspects were detailed. From 44 to 90% of the patients receiving home-based SPC died at home. Studies including survival and quality of life had divergent outcomes, and overall performance status did not improve. However, symptom control did improve over time. SIGNIFICANCE OF RESULTS: There is a lack of controlled clinical trials and organizational descriptions regarding home-based SPC for patients with advanced cancer, resulting in poor information and a lack of evidence. Generally, home-based SPC seems to have some positive effect on pain and dyspnea, but more high-quality studies are required.

The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home.

BACKGROUND: The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate whether an accelerated transition process from oncological treatment to continuing SPC at home for patients with incurable cancer results in more patients reaching their preferred place of care and death. The SPC in this trial is enriched with a manualized psychological intervention. METHODS/DESIGN: DOMUS is a controlled randomized clinical trial with a balanced parallel-group randomization (1:1). The planned sample size is 340 in- and outpatients treated at the Department of Oncology at Copenhagen University Hospital. Patients are randomly assigned either to: a) standard care plus SPC enriched with a standardized psychological intervention for patients and caregivers at home or b) standard care alone. Inclusion criteria are incurable cancer with no or limited antineoplastic treatment options. DISCUSSION: Programs that facilitate transition from hospital treatment to SPC at home for patients with incurable cancer can be a powerful tool to improve patients' quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient's preferred place of care and attempt to clarify challenges. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01885637.

At cancer diagnosis: a 'window of opportunity' for behavioural change towards physical activity. A randomised feasibility study in patients with colon and breast cancer.

INTRODUCTION: Challenges exist in identifying, recruiting and motivating sedentary patients with cancer to initiate physical activity towards recommended levels. We hypothesise that the onset period of adjuvant chemotherapy can be 'the open window of opportunity' to identify and motivate sedentary patients with breast and colon cancers, at risk for developing coronary heart disease, to initiate and sustain lifestyle changes. AIMS: To investigate the feasibility of oncologists/nurses screening for physical inactivity, in order to identify and recruit an at-risk population of sedentary patients with breast or colon cancer at the onset of adjuvant chemotherapy. Furthermore, the study will examine the adherence to one of two multimodal exercise interventions lasting 12 weeks; (1) hospital-based, high intensity, group exercise intervention (2) home-based, low intensity, individual, pedometer intervention. Both arms will be compared with a control group. METHODS AND ANALYSES: All newly referred patients will be screened for sedentary behaviour, using national recommendations. Testing at baseline, 6, 12 and 39 weeks will include; (1) physiological testing (VO2-peak, one repetition maximum muscle strength and lung function (2) fasting full body dual-energy X-ray absorptiometry scan (3) fasting blood glucose, insulin, lipids and cholesterols, (4) psychometric questionnaires (general well-being, quality of life, anxiety and depression, motivational readiness). The randomised controlled trial feasibility design is selected in order to examine barriers for recruitment, programme adherence, safety aspects and potential efficacy to the interventions during adjuvant chemotherapy. ETHICS AND DISSEMINATION: The Scientific Committee of the Capital Region (case No. H-1-2011-131) and the Danish Data Protection Agency (j. No. 2011-41-6349) approved the study. Data will be entered and locked into a database hosted by the Copenhagen Trial Unit, Rigshosptialet. Data will be available for analyses to project members and the trial statistician after the 45 included patients have completed the 12-week test. Results will be published in peer-reviewed scientific journals. TRIAL REGISTRATION: Current Controlled Trials ISRCTN24901641.

Predictors of effects of lifestyle intervention on diabetes mellitus type 2 patients.

The main aim of the study was to identify predictors of the effects of lifestyle intervention on diabetes mellitus type 2 patients by means of multivariate analysis. Data from a previously published randomised clinical trial, which compared the effects of a rehabilitation programme including standardised education and physical training sessions in the municipality's health care centre with the same duration of individual counseling in the diabetes outpatient clinic, were used. Data from 143 diabetes patients were analysed. The merged lifestyle intervention resulted in statistically significant improvements in patients' systolic blood pressure, waist circumference, exercise capacity, glycaemic control, and some aspects of general health-related quality of life. The linear multivariate regression models explained 45% to 80% of the variance in these improvements. The baseline outcomes in accordance to the logic of the regression to the mean phenomenon were the only statistically significant and robust predictors in all regression models. These results are important from a clinical point of view as they highlight the more urgent need for and better outcomes following lifestyle intervention for those patients who have worse general and disease-specific health.

Health-related quality of life and self-related health in patients with type 2 diabetes: effects of group-based rehabilitation versus individual counselling.

BACKGROUND: Type 2 diabetes can seriously affect patients' health-related quality of life and their self-rated health. Most often, evaluation of diabetes interventions assess effects on glycemic control with little consideration of quality of life. The aim of the current study was to study the effectiveness of group-based rehabilitation versus individual counselling on health-related quality of life (HRQOL) and self-rated health in type 2 diabetes patients. METHODS: We randomised 143 type 2 diabetes patients to either a six-month multidisciplinary group-based rehabilitation programme including patient education, supervised exercise and a cooking-course or a six-month individual counselling programme. HRQOL was measured by Medical Outcomes Study Short Form 36-item Health Survey (SF-36) and self-rated health was measured by Diabetes Symptom Checklist - Revised (DCS-R). RESULTS: In both groups, the lowest estimated mean scores of the SF36 questionnaire at baseline were "vitality" and "general health". There were no significant differences in the change of any item between the two groups after the six-month intervention period. However, vitality-score increased 5.2 points (p = 0.12) within the rehabilitation group and 5.6 points (p = 0.03) points among individual counselling participants.In both groups, the highest estimated mean scores of the DSC-R questionnaire at baseline were "Fatigue" and "Hyperglycaemia". Hyperglycaemic and hypoglycaemic distress decreased significantly after individual counselling than after group-based rehabilitation (difference -0.3 points, p = 0.04). No between-group differences occurred for any other items. However, fatigue distress decreased 0.40 points within the rehabilitation group (p = 0.01) and 0.34 points within the individual counselling group (p < 0.01). In the rehabilitation group cardiovascular distress decreased 0.25 points (p = 0.01). CONCLUSIONS: A group-based rehabilitation programme did not improve health-related quality of life and self-rated health more than an individual counselling programme. In fact, the individual group experienced a significant relief in hyper- and hypoglycaemic distress compared with the rehabilitation group.However, the positive findings of several items in both groups indicate that lifestyle intervention is an important part of the management of type 2 diabetes patients.

Effect of a group-based rehabilitation programme on glycaemic control and cardiovascular risk factors in type 2 diabetes patients: the Copenhagen Type 2 Diabetes Rehabilitation Project.

OBJECTIVE: To compare the effectiveness of a group-based rehabilitation programme with an individual counselling programme at improving glycaemic control and cardiovascular risk factors among patients with type 2 diabetes. METHODS: We randomised 143 adult type 2 diabetes patients to either a 6-month multidisciplinary group-based rehabilitation programme or a 6-month individual counselling programme. Outcome measures included glycated haemoglobin (HbA(1c)), blood pressure, lipid profile, weight, and waist circumference. RESULTS: Mean HbA(1c) decreased 0.3%-point (95% confidence interval [CI] = -0.5, -0.1) in the rehabilitation group and 0.6%-point (95% CI = -0.8, -0.4) among individual counselling participants (p<0.05). Within both groups, equal reductions occurred in body weight, waist circumference, systolic blood pressure and diastolic blood pressure, but no significant between-group differences between occurred for any of the cardiovascular outcomes. The group-based rehabilitation programme consumed twice as many personnel resources. CONCLUSION: The group-based rehabilitation programme resulted in changes in glycaemic control and cardiovascular risk factor reduction that were equivalent or inferior to those of an individual counselling programme. PRACTICE IMPLICATIONS: The group-based rehabilitation programme, tested in the current design, did not offer additionally improved outcomes and consumed more personnel resources than the individual counselling programme; its broad implementation is not supported by this study. Trial registration Clinicaltrials.gov NCT00284609.

Lifestyle intervention for type 2 diabetes patients: trial protocol of The Copenhagen Type 2 Diabetes Rehabilitation Project.

BACKGROUND: Current guidelines recommend education, physical activity and changes in diet for type 2 diabetes patients, yet the composition and organization of non-pharmacological care are still controversial. Therefore, it is very important that programmes aiming to improve non-pharmacological treatment of type 2 diabetes are developed and evaluated. The Copenhagen Type 2 Diabetes Rehabilitation Project aims to evaluate the effectiveness of a new group-based lifestyle rehabilitation programme in a Health Care Centre in primary care. METHODS/DESIGN: The group-based diabetes rehabilitation programme consists of empowerment-based education, supervised exercise and dietary intervention. The effectiveness of this multi-disciplinary intervention is compared with conventional individual counselling in a Diabetes Outpatient Clinic and evaluated in a prospective and randomized controlled trial. During the recruitment period of 18 months 180 type 2 diabetes patients will be randomized to the intervention group and the control group. Effects on glycaemic control, quality of life, self-rated diabetes symptoms, body composition, blood pressure, lipids, insulin resistance, beta-cell function and physical fitness will be examined after 6, 12 and 24 months. DISCUSSION: The Copenhagen Type 2 Diabetes Rehabilitation Project evaluates a multi-disciplinary non-pharmacological intervention programme in a primary care setting and provides important information about how to organize non-pharmacological care for type 2 diabetes patients. TRIAL REGISTRATION: (ClinicalTrials.gov) registration number: NCT00284609.