Clinical trial NCT03029182: Simulated-altitude to Optimize Aerobic Exercise Among Breast Cancer Survivors With Limited Mobility
Official title: Simulated-Altitude as an Adjunct to Optimize Aerobic Exercise in Obese Breast Cancer Survivors With Limited Ambulatory Function: Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Breast Cancer
Keywords: Exercise
Cancer
Obesity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Physician's medical clearance for participation
2. English-speaking women
3. 18-70 years of age with a history of Stage 0-III breast cancer
4. 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)
5. Body mass index between 30-45 kg/m2
6. ≥1 year post-treatment and not currently receiving or planning to receive chemo/radiation therapies
7. Not participating in a structured exercise routine
8. 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:

1. Males
2. Dementia
3. 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)
4. Contraindication to participate in regular exercise training
5. Unwilling to complete prescribed exercise
6. Inability to walk
7. Pregnant
8. Resting oxygen saturation via pulse oximetry below 90%
9. Using home oxygen therapy

Primary outcomes:
measure: Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on retention.
timeFrame: baseline to 8 weeks
measure: Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on adherence to exercise compliance.
timeFrame: baseline to 8 weeks
measure: Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on number of adverse events.
timeFrame: baseline to 8 weeks
Secondary outcomes:
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by a 6 minute walk.
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by the cardiorespiratory fitness.
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by arterial elasticity.
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by resting heart rate variability.
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by the fasting glucose.
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by C-reactive protein (mg/L) serum assays.
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by tumor-necrosis factor-alpha (pg/mL) assays.
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-6 (pg/mL) serum assays.
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-10 (pg/mL) serum assays.
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by body composition (% body fat).
timeFrame: baseline to 8 weeks
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by free-living physical activity.
timeFrame: baseline to 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: