Exercise in older women with breast cancer during systemic therapy: study protocol of a randomised controlled trial (BREACE).

INTRODUCTION: Exercise interventions have been widely investigated in patients with cancer and demonstrate beneficial effects. However, intervention studies that include older women with breast cancer exercising during medical treatment are scarce. Hence, the aim of this study is to investigate the effect of a 12-week exercise-based intervention in older women (≥65 years) with breast cancer receiving (neo)adjuvant or first-line or second-line systemic therapy. METHODS AND ANALYSIS: This is a single-centre, two-armed randomised controlled trial. We anticipate including 100 patients, who will be randomised 1:1 to exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors). The intervention group will receive standard oncological treatment and a 12-week supervised exercise-based intervention comprising a progressive resistance exercise programme two times per week, a protein supplement after exercise and a home-based walking programme based on daily step counts. The control group will receive standard oncological treatment. Assessments will be performed at baseline and 6, 12 and 24 weeks after start of the intervention. Primary outcome is physical function, measured by the 30-second Chair Stand Test. Secondary outcomes are feasibility (compliance and adherence to intervention), objective and patient-reported functional measures (6-meter and 10-meter gait speed; 6-min Walk Test; Handgrip Strength; Stair Climb Test; Physical Activity Questionnaire), symptom burden and well-being (MD Anderson Symptom Inventory; Hospital Anxiety and Depression Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 and B23), body composition (dual-energy X-ray absorptiometry scan), side effects, inflammatory biomarkers, hospitalisation and survival. ETHICS AND DISSEMINATION: The protocol was reviewed and accepted by the Scientific Ethics Review Committee of the Capital Region of Denmark, 17 June 2018 (VEK ref.: H-18021013). Trial results will be submitted for publication in a peer-reviewed journal and presented on conferences, in oncology wards, exercise centres in municipalities and patient organisations, ensuring dissemination to relevant stakeholders. TRIAL REGISTRATION NUMBER: https://clinicaltrials.gov/ on 3 September 2018. Identifier: NCT03656731.

Physical Fitness and Body Composition in 10-12-Year-Old Danish Children in Relation to Leisure-Time Club-Based Sporting Activities.

This study investigated whether the physical fitness and body composition of 10-12-year-old Danish children are related to participation in leisure-time club-based sporting activities. The study involved 544 Danish 10-12-year-old 5th-grade municipal schoolchildren (269 boys and 275 girls, 11.1 ± 0.4 years). After answering a questionnaire about leisure-time sporting activities, the children were divided into four groups: football club participation (FC; n=141), other ball games (OBG; n=42), other sports (OS; n=194), and no sports-club participation (NSC; n=167). The children completed a battery of health and fitness tests, including a 20 m sprint test, a standing long-jump test, the Yo-Yo IR1 children's test (YYIR1C), and body composition, blood pressure, resting heart rate (HRrest), and the flamingo balance test. The children engaged in club-based ball games (FC and OBG) had higher (p<0.05) lean body mass than NSC (FC: 17.5 ± 2.9; OBG: 18.4 ± 2.6; OS: 16.7 ± 2.9; NSC: 16.4 ± 2.8 kg), performed better (p<0.05) in the YYIR1C test (FC: 1083 ± 527; OBG: 968 ± 448; OS: 776 ± 398; NSC: 687 ± 378 m), and had lower (p<0.05) %HRmax after 1, 2, and 3 min of YYIR1C. Moreover, HRrest was lower (p<0.05) for FC than for OS and NSC (FC: 68 ± 9 vs OS: 72 ± 10 and NSC: 75 ± 10 bpm), and lower (p<0.05) for OBG than for NSC (OBG: 70 ± 10 vs NSC: 75 ± 10 bpm). This study found that 10-12-year-old Danish children engaged in club-based football and other ball games had better exercise capacity, lower resting heart rate, and higher muscle mass than children not engaged in leisure-time sports. Thus, participation in club-based leisure-time ball-game activities seems to be of importance for the fitness and health profile of prepubertal children.