Deli‐Conwright 2014.

Trial name or title	Exercise Program for Early Breast Cancer Survivors
Methods	Accrual: not reported Accrual target: 100 breast cancer survivors Multi‐centre/single‐centre: single centre, but participants will be encouraged in a home‐based exercise session over 30 to 45 minutes once weekly Phase of trial: not reported Country where trial is being conducted: USA (Los Angeles, CA) Any intended follow‐up details: 12 weeks Stated study design: RCT, efficacy study
Participants	Inclusion criteria: • Newly diagnosed (I‐III) first primary invasive breast cancer • Underwent lumpectomy or mastectomy • Completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise programme (if randomised to that arm) within 12 weeks of therapy completion • Body mass index (BMI) > 25 kg/m² or body fat > 30% (as determined by Dr. Dieli‐Conwright at baseline visit) • Currently participate in less than 60 minutes of physical activity per week • May use adjuvant endocrine therapy if use will be continued for duration of study period • Non‐smoker (i.e. not smoking during previous 12 months) • Willing to travel to the exercise facility and USC • Able to provide physician clearance to participate in exercise programme • Women of all racial and ethnic backgrounds to be included in the study enrolment process Exclusion criteria: • History of chronic disease including diabetes, uncontrolled hypertension, or thyroid disease • Weight reduction ≥ 10% in the past 6 months • Diagnosis of human epidermal growth factor receptor 2 (HER2)‐positive tumour (exclusion due to patient use of Herceptin medication for 1 year following chemotherapy) • Metastatic disease • Planned reconstructive surgery with flap repair during trial and follow‐up period • Cardiovascular, respiratory, or musculoskeletal disease or joint problems that preclude moderate physical activity
Interventions	ARM 1: Intervention details: Participants complete supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home‐based exercise session over 30 to 45 minutes once weekly for 16 weeks. ARM 2: Comparator details: Participants refrain from increasing physical activity levels for 16 weeks.
Outcomes	Primary outcome: Change in components of metabolic syndrome (i.e. hypertension, high waist circumference, hyperglycaemia, low/high‐density lipoproteins, elevated triglycerides) Secondary outcomes: Cardiorespiratory fitness (4‐minute walk test) Muscle strength (10‐RM leg extension, leg flexion, chest press, seated row) Body composition (DEXA, weight, height, lean mass, % body fat, hip circumference) Quality of life (SF‐36, FACT‐B, CES‐D) Shoulder strength (muscle force for scapular plane elevation and external rotation) Shoulder function (measured with goniometer at 90° external rotation, forward flexion) Upper limb musculoskeletal disorder assessment (Disabilities of the Arm, Shoulder, and Hand ‐ DASH ‐ and Penn Shoulder Scale ‐ PSS) Biomarkers ‐ inflammation and endocrine function (analysed in peripheral blood)
Starting date	Start date: May 2012 Estimated completion date: May 2017
Contact information	Christina Dieli‐Conwright, PhD; 323‐442‐2905 Email: cdieli@usc.edu
Notes	Trial registration link: https://clinicaltrials.gov/show/NCT01140282 Sponsor of the trial: University of Southern California, National Cancer Institute This study is still recruiting participants. Intention‐to‐treat analysis: not reported Funding considerations: not funded by Pharma or otherwise