title: Physical Activity and Lymphedema (the PAL trial): assessing the safety of progressive strength training in breast cancer survivors.
abstract: Lymphedema is a chronic and progressive long-term adverse effect of breast cancer treatment commonly defined by swelling of the affected arm. Current clinical guidelines indicate that women with and at risk for lymphedema should protect the affected arm from overuse. In clinical practice, this often translates into risk aversive guidance to avoid using the arm. This could lead to a disuse pattern that may increase the likelihood of injury from common activities of daily living. Further, such guidance poses an additional barrier to staying physically active, potentially translating to weight gain, which has been shown to be associated with worse clinical course for women with lymphedema. We hypothesize that a program of slowly progressive strength training with no upper limit on the amount of weight that may be lifted would gradually increase the physiologic capacity of the arm so that common activities represent a decreasing percentage of maximal capacity. Theoretically, this increased capacity should decrease the risk that daily activities put stress on the lymphatic system of the affected side. The Physical Activity and Lymphedema (PAL) Trial is a recently completed randomized controlled exercise intervention trial that recruited 295 breast cancer survivors (141 with lymphedema at study entry, 154 at risk for lymphedema at study entry). The purpose of this report is to provide detail regarding the study design, statistical design, and protocol of the PAL trial.
authors.affiliation: Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA 19104-6021, USA. Schmitz@mail.med.upenn.edu
authors.forename: Kathryn H
authors.initials: KH
authors.lastname: Schmitz
authors.forename: Andrea B
authors.initials: AB
authors.lastname: Troxel
authors.forename: Andrea
authors.initials: A
authors.lastname: Cheville
authors.forename: Lorita L
authors.initials: LL
authors.lastname: Grant
authors.forename: Cathy J
authors.initials: CJ
authors.lastname: Bryan
authors.forename: Cynthia R
authors.initials: CR
authors.lastname: Gross
authors.forename: Leslie A
authors.initials: LA
authors.lastname: Lytle
authors.forename: Rehana L
authors.initials: RL
authors.lastname: Ahmed
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000523:psychology / Q000532:radiotherapy / Q000534:rehabilitation* / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008209:Lymphedema / Q000523:psychology / Q000534:rehabilitation*; D008875:Middle Aged; D011183:Postoperative Complications / Q000523:psychology / Q000534:rehabilitation*; D011788:Quality of Life / Q000523:psychology; D055070:Resistance Training / Q000009:adverse effects; D017741:Survivors