None listed
Conditions
Brief summary
This study aims to investigate whether an exercise program reduces swelling in women with breast lymphoedema symptoms secondary to breast ca ncer. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who has stage I-III breast cancer which has been surgically treated. You should have had stable breast lymphoedema for at least 3 months and be sedentary. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will participate in an exercise program that consists of 3 x 1 hour training sessions per week for 12 weeks. A trainer will meet women in this group at their local community gym 3 x per week for the first 2 weeks then reducing to once a week for the rest of the program. The program will consist of a 5 min warm-up, followed by 20 min of moderate to vigorous intensity aerobic exercise and 30 min resistance exercise in the limbs and trunk using free weights and resistance equipment, and finishing with a 5 min cool down. Participants in the second group will receive no exercise p rogram. Participants in both groups will be contacted by the study coordinator on a weekly basis to monitor their progress. Participants will also undergo clinical assessment at baseline and 3 months, and be asked to complete questionnaires about their symptoms, quality of life and dietary intake.
Interventions
Exercise programme - exercise training will run for 12 weeks, 3 x per week for approx 1 hr each session. Exercise sessions are indivual-based; while the exercise program is standardised, the intensity will be based on the woman's fitness level.
A trainer will meet women at their local community gym 3 x per week for the first 2 weeks then reducing to once a week for the rest of the program. The program will consist of 5 min warm-up, 20 min moderate - vigorous intensity aerobic exercise and 30
Exercise programme - exercise training will run for 12 weeks, 3 x per week for approx 1 hr each session. Exercise sessions are indivual-based; while the exercise program is standardised, the intensity will be based on the woman's fitness level. A trainer will meet women at their local community gym 3 x per week for the first 2 weeks then reducing to once a week for the rest of the program. The program will consist of 5 min warm-up, 20 min moderate - vigorous intensity aerobic exercise and 30 mins resistance exercise in the limbs and trunk using free weights and resistance equipment, and 5 min cool down. Participants will be contacted on a weekly basis via phone calls by the study coodinator to check on their progress and that they are adhering to the exercise protocol 3 x a week, to maintain motivation and record the use of resources, and to monitor for any changes in their lymphoedema status. Additionally, a semi-quantitative food frequency questionnaire will be emailed to participants on a monthly basis to assess their dietary intakes.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage I-III breast cancer and treated with wide local excision and axillary surgery for their breast cancer; have developed unilateral breast lymphoedema ; have had stable lymphoedema for at least 3 months; and are sedentary.
Exclusion criteria
Have had surgery for their breast cancer within the last 3 months; currently having active treatment for cancer; have a history of bilateral lymph node dissection; have a history of primary lymphoedema ; have had intensive therapy for their lymphoedema within the last 3 months; have had an infection requiring antibiotic treatment in the lymphoedematous region within the last 3 months; are unable to elevate their upper limbs by > 120 degrees minimum; have musculoskeletal or neurological conditions that would affect exercise training and/or assessments; and have any medical conditions (including surgeries) that could prevent participation in exercise.
Outcome results
None listed