University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: 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).
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Notify Me18 year–70 year
Female
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: baseline to 8 weeks
number of participants completing the 8 week session
Time frame: baseline to 8 weeks
mean compliance among all participantswith exercise prescription
Time frame: baseline to 8 weeks
Number of adverse events in each group
Time frame: baseline to 8 weeks
6 minute walk test, a valid and reliable tool in cancer survivors will be used to evaluate cardiovascular health and mobility. Total distance (in meters) covered over the duration of 6 minutes will be recorded.
Time frame: baseline to 8 weeks
Cardiorespiratory fitness, will be measured by indirect calorimetry during a graded walking test on a treadmill to estimate peak aerobic capacity.
Time frame: baseline to 8 weeks
Arterial elasticity, will be measured by local pulse contour analyses (HDI/Pulse Wave), A non-invasive procedure based on a modified Windkessel model which permits the evaluation of vascular health.
Time frame: baseline to 8 weeks
Heart rate variability, will be determined by R-to-R interval variations in heart rate, used to index sympatho-vagal balance.
Time frame: baseline to 8 weeks
Typically, a "normal" blood sugar level is identified by experts as anything less than 100 mg/dL after a period of fasting.
Time frame: baseline to 8 weeks
Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
Time frame: baseline to 8 weeks
Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
Time frame: baseline to 8 weeks
Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
Time frame: baseline to 8 weeks
Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
Time frame: baseline to 8 weeks
Body composition, will be measured by dual-energy X-ray absorptiometry during which participants will be scanned while lying supine in light clothing with their arms at their sides.
Time frame: baseline to 8 weeks
Free-living physical activity, will be measured by a triaxial accelerometer (e.g., Actigraph GT3X). Participants will wear the accelerometer on the hip of their non-dominant side during waking periods and around the wrist when sleeping according to a previously published protocol.
University of Alabama at Birmingham
Other
Simulated-Altitude as an Adjunct to Optimize Aerobic Exercise in Obese Breast Cancer Survivors With Limited Ambulatory Function: Pilot Randomized Trial
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