The Effect of Resistive Exercise on Forearm Blood Flow and Tissue Oxygenation Among Breast Cancer Survivors With or at Risk for Breast Cancer-related Lymphoedema (BCRL)
Condition: Lymphedema; Breast Cancer
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of resistive exercise on forearm blood
      flow and tissue oxygenation among breast cancer survivors with or at risk for breast
      cancer-related lymphoedema (BCRL).
    

Detailed description: 
      160 subjects who have a diagnosis of breast cancer , 80 with and 80 without BCRL, will be
      recruited. Eligible subjects are Chinese ethnicity female breast cancer survivors, aged
      younger than 70 years old and body mass index less than 30kg/m2, remained disease free with a
      clinical diagnosis of stable BCRL and without BCRL. Subjects will be excluded if they have
      bilateral or unstable BCRL, defined as significant changes to the arm or receiving intensive
      therapy (i.e. decongestive therapy or antibiotics for infection) within the past 3 months, or
      musculoskeletal, cardiovascular and/ or neurological disorders that could inhibit them from
      exercising.

      Primary outcomes include brachial artery blood flow measured by a Doppler ultrasound device
      and tissue oxygenation measured by near-infrared spectroscopy (NIRS). Additional outcomes and
      measures include arm circumference measurement, bioelectrical impedance spectroscopy,
      self-reported lymphoedema symptoms survey, handgrip dynamometer strength testing, upper limb
      range of motion measurements and quality of life measures using Functional Assessment of
      Cancer Therapy-Breast Cancer subscale (FACT-B) questionnaire will be obtained.

      All outcomes measures will be assessed on both affected and contralateral unaffected arms of
      all subjects at pre-exercise, immediately post-exercise and 3-month after exercise.
      Comparison of the baseline measurements between breast cancer survivors with and without BCRL
      will be obtained.

      Subjects will be randomly assigned by computer programme to exercise group and control group.
      Randomization will be stratified by whether axillary dissection and/ or axilla radiotherapy
      was given or not. The exercise group will receive supervised resistive exercise programme.
      Subjects in the exercise group will attend small group-based exercise sessions twice a week
      for 8 weeks supervised by physiotherapists. The duration of each exercise session will last
      for approximately 1 hour. Prior to resistive exercises, the subjects will perform warm up
      with movements of large joints and shoulder girdle for 15 minutes. Resistive exercises will
      focus on the major muscle groups in the upper body. Loading of resistive exercises will be
      prescribed and progressed according to individual capacity reaching a level of moderate to
      high loading (6 -12 repetition maximum). The subjects will also be instructed to perform
      stretching exercises specific to the muscle groups trained after the session. Symptoms
      responses will be monitored using self-reported lymphoedema symptoms survey before and after
      each exercise session. Rate of perceived exertion will also be recorded immediately after
      each exercise session.
    

Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): 8-week resistive exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Exercise; blood flow velocity; tissue oxygenation; BCRL