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Simulated-altitude to Optimize Aerobic Exercise Among Breast Cancer Survivors With Limited Mobility

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ClinicalTrials.gov Identifier: NCT03029182
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

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).

Condition or disease Intervention/treatment Phase
Obesity Breast Cancer Other: Walking+simulated-altitude Behavioral: Walking (control) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simulated-Altitude as an Adjunct to Optimize Aerobic Exercise in Obese Breast Cancer Survivors With Limited Ambulatory Function: Pilot Randomized Trial
Study Start Date : October 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Walking+simulated-altitude
8-week exercise training program that involves 3 supervised, treadmill walking sessions each week with 16% oxygen, which will be administered through an exercise mask.
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.

Active Comparator: Walking (control)
8-week exercise training program that involves 3 supervised, treadmill walking session each week.
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.




Primary Outcome Measures :
  1. Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on retention. [ Time Frame: baseline to 8 weeks ]
    number of participants completing the 8 week session

  2. Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on adherence to exercise compliance. [ Time Frame: baseline to 8 weeks ]
    mean compliance among all participantswith exercise prescription

  3. Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on number of adverse events. [ Time Frame: baseline to 8 weeks ]
    Number of adverse events in each group


Secondary Outcome Measures :
  1. The effect sizes for walking+simulated-altitude and walking (control) as measured by a 6 minute walk. [ 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.

  2. The effect sizes for walking+simulated-altitude and walking (control) as measured by the cardiorespiratory fitness. [ 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.

  3. The effect sizes for walking+simulated-altitude and walking (control) as measured by arterial elasticity. [ 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.

  4. The effect sizes for walking+simulated-altitude and walking (control) as measured by resting heart rate variability. [ 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.

  5. The effect sizes for walking+simulated-altitude and walking (control) as measured by the fasting glucose. [ 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.

  6. The effect sizes for walking+simulated-altitude and walking (control) as measured by C-reactive protein (mg/L) serum assays. [ 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.

  7. The effect sizes for walking+simulated-altitude and walking (control) as measured by tumor-necrosis factor-alpha (pg/mL) assays. [ 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.

  8. The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-6 (pg/mL) serum assays. [ 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.

  9. The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-10 (pg/mL) serum assays. [ 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.

  10. The effect sizes for walking+simulated-altitude and walking (control) as measured by body composition (% body fat). [ 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.

  11. The effect sizes for walking+simulated-altitude and walking (control) as measured by free-living physical activity. [ 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029182


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham

Responsible Party: Laura Q. Rogers, MD, MPH, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03029182     History of Changes
Other Study ID Numbers: F160215001
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham:
Exercise
Cancer
Obesity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases