ObesityNCT03029182
Simulated-altitude to Optimize Aerobic Exercise Among Breast Cancer Survivors With Limited Mobility
A study testing Walking+simulated-altitude in people with Obesity and Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Obesity, Breast Cancer
- What is being tested?
- Walking+simulated-altitude
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Pregnant
- Resting oxygen saturation via pulse oximetry below 90%
- Using home oxygen therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Simulated-Altitude as an Adjunct to Optimize Aerobic Exercise in Obese Breast Cancer Survivors With Limited Ambulatory Function: Pilot Randomized Trial
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).
Read the 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.
- Conditions
- Obesity, Breast Cancer
- Being tested
- Walking+simulated-altitude, Walking (control)
- Keywords
- Exercise, Cancer, Obesity
- Medical subject headings
- Obesity, Breast Neoplasms, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking+simulated-altitudeOther
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 (control)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Walking+simulated-altitude |
| Walking (control) | Active comparator | 8-week exercise training program that involves 3 supervised, treadmill walking session each week. Receives: Behavioral: Walking (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: baseline to 8 weeks
Secondary outcomes (11)
The effect sizes for walking+simulated-altitude and walking (control) as measured by a 6 minute walk.
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.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by the cardiorespiratory fitness.
Cardiorespiratory fitness, will be measured by indirect calorimetry during a graded walking test on a treadmill to estimate peak aerobic capacity.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by arterial elasticity.
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.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by resting heart rate variability.
Heart rate variability, will be determined by R-to-R interval variations in heart rate, used to index sympatho-vagal balance.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by the fasting glucose.
Typically, a "normal" blood sugar level is identified by experts as anything less than 100 mg/dL after a period of fasting.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by C-reactive protein (mg/L) serum assays.
Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by tumor-necrosis factor-alpha (pg/mL) assays.
Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-6 (pg/mL) serum assays.
Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-10 (pg/mL) serum assays.
Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by body composition (% body fat).
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.
Measured: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by free-living physical activity.
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.
Measured: baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029182
- Sponsor's protocol ID
- F160215001
- Status last verified
- May 2018
- First submitted
- 12 Jan 2017
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated-Altitude as an Adjunct to Optimize Aerobic Exercise in Obese Breast Cancer Survivors With Limited Ambulatory Function: Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT03029182
- Acronym / sponsor ID
- F160215001
- Conditions
- Obesity, Breast Cancer
- Keywords
- Exercise, Cancer, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking+simulated-altitude | Experimental | Other: Walking+simulated-altitude8-week exercise training program that involves 3 supervised, treadmill walking sessions each week with 16% oxygen, which will be administered through an exercise mask. |
| Walking (control) | Active comparator | Behavioral: Walking (control)8-week exercise training program that involves 3 supervised, treadmill walking session each week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking+simulated-altitudeParticipants 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. | Other | Walking+simulated-altitude |
| 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. | Behavioural | Walking (control) |
Primary outcome
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
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
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
11 secondary outcomes
The effect sizes for walking+simulated-altitude and walking (control) as measured by a 6 minute walk.
Time frame: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by the cardiorespiratory fitness.
Time frame: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by arterial elasticity.
Time frame: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by resting heart rate variability.
Time frame: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by the fasting glucose.
Time frame: baseline to 8 weeks
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
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
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
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
The effect sizes for walking+simulated-altitude and walking (control) as measured by body composition (% body fat).
Time frame: baseline to 8 weeks
The effect sizes for walking+simulated-altitude and walking (control) as measured by free-living physical activity.
Time frame: baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking+simulated-altitude in people with Obesity and Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.