Skip to main content

Advertisement

Table 1 Trial registration data

From: 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

Trial registration data
Primary registry and trial identify number Current Controlled Trials ISRCTN97332727.
Date of registration in primary registry 12 February 2015.
Secondary identifying numbers H-3-2014-147, 30-1430
Source of monetary or material support University Hospitals Centre for Health Research, Copenhagen University Hospital Rigshospitalet
Primary sponsor University Hospitals Centre for Health Research, Copenhagen University Hospital Rigshospitalet
Secondary sponsor
Contact for public queries KB, MHS, PhD-stud. kibl30@hotmail.com, (45) 35347362, Blegdamsvej 9 (afsnit 9701), 2100 Copenhagen
Contract for scientific queries KB, MHS, PhD-stud. kibl30@hotmail.com, (45) 35347362, Blegdamsvej 9 (afsnit 9701), 2100 Copenhagen
Public title A 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
Scientific 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
Countries of recruitment Denmark
Health condition or problem studied Breast cancer-related arm lymphedema
Intervention Heavy vs low load resistance exercise for the upper extremities
Key inclusion and exclusion criteria Inclusion criteria: > 18 years of age, unilateral breast surgery, axillary node dissection, undergoing adjuvant chemotherapy for breast cancer
Exclusion criteria: Previously treated for breast cancer, diagnosis of BCRL and/or currently receiving treatment for BCRL, or having conditions hampering resistance exercise of the upper body, or having participated in regular upper-body heavy resistance exercise during the last month
Study type Interventional
Randomized cross-over, assessor blinded
Safety
Date of first enrolment 31-03-2015
Target sample size 40
Recruitment status Recruiting
Primary outcome Arm extracellular fluid (L-dex score) post-, 24- and 72 h post exercise
Key secondary outcomes Arm volume (ml) post-, 24- and 72 h post exercise