Table 1 Trial registration data
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: > 18Â 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 72Â h post exercise |
Key secondary outcomes | Arm volume (ml) post-, 24- and 72Â h post exercise |