title: A randomized cross-over trial to detect differences in arm volume after low- and heavy-load resistance exercise among patients receiving adjuvant chemotherapy for breast cancer at risk for arm lymphedema: study protocol.
abstract: In an effort to reduce the risk of breast cancer-related arm lymphedema, patients are commonly advised to avoid heavy lifting, impacting activities of daily living and resistance exercise prescription. This advice lacks evidence, with no prospective studies investigating arm volume changes after resistance exercise with heavy loads in this population. The purpose of this study is to determine acute changes in arm volume after a session of low- and heavy-load resistance exercise among women undergoing adjuvant chemotherapy for breast cancer at risk for arm lymphedema.
  
  
  
  This is a randomized cross-over trial.
  
  
  
  Women receiving adjuvant chemotherapy for breast cancer who have undergone axillary lymph node dissection will be recruited from rehabilitation centers in the Copenhagen area.
  
  
  
  Participants will be randomly assigned to engage in a low- (two sets of 15-20 repetition maximum) and heavy-load (three sets of 5-8 repetition maximum) upper-extremity resistance exercise session with a one week wash-out period between sessions.
  
  
  
  Changes in extracellular fluid (L-Dex score) and arm volume (ml) will be assessed using bioimpedance spectroscopy and dual-energy x-ray absorptiometry, respectively. Symptom severity related to arm lymphedema will be determined using a visual analogue scale (heaviness, swelling, pain, tightness). Measurements will be taken immediately pre- and post-exercise, and 24- and 72-hours post-exercise.
  
  
  
  A sample size of 20 participants was calculated based on changes in L-Dex scores between baseline and 72-hours post exercise sessions.
  
  
  
  Findings from this study are relevant for exercise prescription guidelines, as well as recommendations regarding participating in activities of daily living for women following surgery for breast cancer and who may be at risk of developing arm lymphedema.
  
  
  
  Current Controlled Trials ISRCTN97332727 . Registered 12 February 2015.
authors.affiliation: University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark. kibl30@hotmail.com.
authors.forename: Kira
authors.identifier: 0000-0001-7434-0532
authors.initials: K
authors.lastname: Bloomquist
authors.affiliation: Institute of Health and Biomedical Innovation, Queensland University of Technology, 60 Musk Avenue, Kelvin Grove Urban Village, Kelvin Grove, Queensland, 4059, Australia.
authors.forename: Sandi
authors.initials: S
authors.lastname: Hayes
authors.affiliation: University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.
authors.forename: Lis
authors.initials: L
authors.lastname: Adamsen
authors.affiliation: University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.
authors.forename: Tom
authors.initials: T
authors.lastname: Møller
authors.affiliation: Department of Public Health; Section of Biostatistics, University of Copenhagen, Øster Farimagsgade 5, 1014, Copenhagen K, Denmark.
authors.forename: Karl Bach
authors.initials: KB
authors.lastname: Christensen
authors.affiliation: DBCG, Afsnit 2501, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.
authors.forename: Bent
authors.initials: B
authors.lastname: Ejlertsen
authors.affiliation: Department of Clinical Physiology, Nuclear Medicine and PET, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Oturai
mesh_terms: D000203:Activities of Daily Living; D000072656:Breast Cancer Lymphedema / Q000517:prevention & control*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000534:rehabilitation; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects*; D018592:Cross-Over Studies; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D011446:Prospective Studies; D055070:Resistance Training / Q000379:methods*; D012720:Severity of Illness Index; D016896:Treatment Outcome
keywords: Breast cancer; Lymphedema; Resistance exercise