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Simulated-Altitude as an Adjunct to Optimize Aerobic Exercise in Obese Breast Cancer Survivors With Limited Ambulatory Function: Pilot Randomized Trial (NCT03029182)

The study will evaluate the utility of hypoxic exercise training to improve cardiovascular and metabolic health among obese breast cancer survivors. While participants exercise, a lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which is believed to support exercise tolerance. Participants are randomized to either the treatment (walking+simulated-altitude) or control (walking under normoxic conditions).
  • Other: Walking+simulated-altitude
    Participants will walk on a treadmill for up to 50 minutes at a 16% oxygen level (administered via exercise mask), which is similar in altitude to Flagstaff, AZ. The progression of exercise training will be based on a varying percents of heart rate reserve.
    • Behavioral: Walking (control)
      Participants will walk on a treadmill for up to 50 minutes.The progression of exercise training will be based on a varying percents of heart rate reserve.
      Ages eligible for Study
      18 Years to 70 Years
      Genders eligible for Study
      Female
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Physician's medical clearance for participation
      • English-speaking women
      • 18-70 years of age with a history of Stage 0-III breast cancer
      • Preferred walking speed of less than 2.9 mph as measured by a timed 10 meter walk test (to be performed on-site after consent during preliminary screening) "OR" the inability to complete a 6-minute walk without stopping (to be performed on-site after consent during preliminary screening)
      • Body mass index between 30-45 kg/m2
      • ≥1 year post-treatment and not currently receiving or planning to receive chemo/radiation therapies
      • Not participating in a structured exercise routine
      • In the previous 6 months, not engaging in (on average) ≥60 minutes of moderate or ≥30 minutes of vigorous physical activity per week.
      Exclusion Criteria:
      • Males
      • Dementia
      • Medical, psychological, and/or social characteristics that may interfere with the ability to fully participate in the proposed study activities/assessments (e.g., psychosis, schizophrenia)
      • Contraindication to participate in regular exercise training
      • Unwilling to complete prescribed exercise
      • Inability to walk
      • Pregnant
      • Resting oxygen saturation via pulse oximetry below 90%
      • Using home oxygen therapy
      Cancer survivors have a two-fold greater risk of having one or more functional limitations compared to those without a history of cancer. Though exercise interventions in breast cancer survivors exist, a large portion of women (61%) exhibit some form of lower-body dysfunction that severely restricts participation in physical activity and exercise. Both physical and emotional well-being are negatively affected by the combination of increased adiposity, orthopedic problems and muscle weakness, thus reinforcing a cycle of physical inactivity.

      For these reasons, obese breast cancer survivors with walking limitations are faced with a barrier that greatly increases the difficulty of meeting prescribed exercise guidelines (≥150 weekly minutes of moderate-to-vigorous intensity exercise). Though previous investigations have demonstrated the safety and benefits of exercise+simulated altitude to improve body fat, physical endurance and insulin sensitivity, results have been limited to non-cancer participants only. Given the comorbidities common to breast cancer survivors, specifically, heart disease risk, lower body joint problems, low aerobic capacity, and fatigue, further research is needed.

      1 locations

      United States (1)
      • University of Alabama at Birmingham
        recruiting
        Birmingham, Alabama, United States, 35233
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      30 September, 2016
      Updated:
      18 January, 2017
      Participants:
      30
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