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

NCT03029182 | Completed

• 1 other identifier: F160215001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Breast Cancer

Keywords

Exercise; Cancer; Obesity

Outcome Measures

Primary Outcomes (3)

• Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on retention.

  number of participants completing the 8 week session

  baseline to 8 weeks

• Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on adherence to exercise compliance.

  mean compliance among all participantswith exercise prescription

  baseline to 8 weeks

• Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on number of adverse events.

  Number of adverse events in each group

  baseline to 8 weeks

Secondary Outcomes (11)

• The effect sizes for walking+simulated-altitude and walking (control) as measured by a 6 minute walk.

  baseline to 8 weeks

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

  baseline to 8 weeks

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

  baseline to 8 weeks

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

  baseline to 8 weeks

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

  baseline to 8 weeks

Study Arms (2)

Walking+simulated-altitude

EXPERIMENTAL

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

Walking (control)

ACTIVE COMPARATOR

8-week exercise training program that involves 3 supervised, treadmill walking session each week.

Behavioral: Walking (control)

Interventions

Walking+simulated-altitude OTHER

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.

Walking+simulated-altitude

Walking (control) BEHAVIORAL

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.

Walking (control)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician's medical clearance for participation
• English-speaking women
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Obesity; Breast Neoplasms; Motor Activity; Neoplasms

Interventions

Walking

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 24, 2017
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

US (1)