Cancer SurvivorsIMOCSNCT05193149
Inspiratory Muscle Training in Obese Breast Cancer Survivors
A study testing Inspiratory muscle training and Exercise training in people with Cancer Survivors and Obesity, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer Survivors, Obesity, Breast Cancer
- What is being tested?
- Inspiratory muscle training and Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 27 Jul 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completed active treatment for a Stage 0-III breast cancer diagnosis within 6 months to 5 years of enrollment.
- obese as defined by a body mass index (BMI) of 30 to 50 kg/m2
- patients who are on adjuvant endocrine therapy will be allowed to participate.
- sedentary (participating in less than 90 min of moderate intensity activity per week) and have at least one limitation in activity on the 10-question RAND-36 Physical Function Subscale to ensure some exercise intolerance
Who cannot join
- functional limitations that make independent exercise unsafe
- metastatic breast cancer
- ongoing or active infection with recent antibiotics or steroids
- Bilateral Axillary lymph node dissection (ALND) of >5 lymph nodes on each side, which could increase risk of lymphadenopathy with repeated blood pressure measurements during exercise or if patient has been advised by their clinician to avoid repeated BP measures on both arms. Bilateral Sentinel Lymph Node Biopsy (SLNB) will be allowed.
- heart disease precluding exercise (congestive heart failure, unstable angina pectoris, cardiac arrhythmia)
- psychiatric illness/social situations that would limit compliance with study requirements
Show all 12Show fewer
- orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
- unwilling or unable to follow protocol requirements
- pregnant or nursing
- any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
- presence of provokable ECG changes suggestive of heart disease, or dangerous arrhythmias or exercise induced hypertension, etc. during the cardiopulmonary exercise test
- non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer
The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors.
Read the detailed description
Randomized controlled trial (RCT) where obese participants (N=133) are randomized to 2 arms: [i] IMT 4 wks + Exercise 12 wks, [ii] SHAM 4 wks + Exercise 12 wks).
- Conditions
- Cancer Survivors, Obesity, Breast Cancer
- Being tested
- Inspiratory muscle training, Exercise training
- Medical subject headings
- Obesity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingBehavioural
Training of respiratory muscles
Exercise trainingBehavioural
Supervised aerobic exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| 4 wk IMT + 12 wk exercise | Experimental | 4 weeks of IMT, 3/week, 3 sets of 15 repetitions, intensity up to 70% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity Receives: Behavioral: Inspiratory muscle training; Behavioral: Exercise training |
| 4 wk SHAM + 12 wk exercise | Sham comparator | 4 weeks of SHAM training, 3/week, 3 sets of 15 repetitions, intensity up of 10% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise tolerance
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Measured: Baseline to 4 weeks
Change in exercise tolerance
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Measured: Baseline to 16 weeks
Secondary outcomes (10)
Change in inspiratory muscle strength
Continuous variable, Maximal inspiratory pressure. Units: cm H20
Measured: Baseline to 4 weeks
Change in inspiratory muscle strength
Continuous variable, Maximal inspiratory pressure. Units: cm H20
Measured: Baseline to 16 weeks
Change in inspiratory muscle endurance
Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min
Measured: Baseline to 4 weeks
Change in inspiratory muscle endurance
Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min
Measured: Baseline to 16 weeks
Change in exercise capacity
Continuous variable, peak oxygen uptake. Units: L/min
Measured: Baseline to 4 weeks
Change in exercise capacity
Continuous variable, peak oxygen uptake. Units: L/min
Measured: Baseline to 16 weeks
Change in dyspnea
Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4
Measured: Baseline to 4 weeks
Change in dyspnea
Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4
Measured: Baseline to 16 weeks
Change in fatigue
Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52
Measured: Baseline to 4 weeks
Change in fatigue
Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start13 Nov 2023
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dharini Bhammar, Ohio State University Comprehensive Cancer Center
- Investigators
- Dharini M Bhammar, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193149
- Sponsor's protocol ID
- OSU-22220
- Acronym
- IMOCS
- Status last verified
- Aug 2026
- First submitted
- 31 Dec 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make deidentified data freely available if requested. The privacy and rights of the participants will be protected.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer
- ClinicalTrials.gov ID
- NCT05193149
- Acronym / sponsor ID
- IMOCS / OSU-22220
- Conditions
- Cancer Survivors, Obesity, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 14 Jan 2022 (actual)
- 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 investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors.
Detailed description
Randomized controlled trial (RCT) where obese participants (N=133) are randomized to 2 arms: [i] IMT 4 wks + Exercise 12 wks, [ii] SHAM 4 wks + Exercise 12 wks).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 wk IMT + 12 wk exercise | Experimental | Behavioral: Inspiratory muscle training, Behavioral: Exercise training4 weeks of IMT, 3/week, 3 sets of 15 repetitions, intensity up to 70% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity |
| 4 wk SHAM + 12 wk exercise | Sham comparator | Behavioral: Exercise training4 weeks of SHAM training, 3/week, 3 sets of 15 repetitions, intensity up of 10% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- completed active treatment for a Stage 0-III breast cancer diagnosis within 6 months to 5 years of enrollment.
- obese as defined by a body mass index (BMI) of 30 to 50 kg/m2
- patients who are on adjuvant endocrine therapy will be allowed to participate.
- sedentary (participating in less than 90 min of moderate intensity activity per week) and have at least one limitation in activity on the 10-question RAND-36 Physical Function Subscale to ensure some exercise intolerance
Key exclusion criteria (12 listed)
- functional limitations that make independent exercise unsafe
- metastatic breast cancer
- ongoing or active infection with recent antibiotics or steroids
- Bilateral Axillary lymph node dissection (ALND) of >5 lymph nodes on each side, which could increase risk of lymphadenopathy with repeated blood pressure measurements during exercise or if patient has been advised by their clinician to avoid repeated BP measures on both arms. Bilateral Sentinel Lymph Node Biopsy (SLNB) will be allowed.
- heart disease precluding exercise (congestive heart failure, unstable angina pectoris, cardiac arrhythmia)
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 |
|---|---|---|
| Inspiratory muscle trainingTraining of respiratory muscles | Behavioural | 4 wk IMT + 12 wk exercise |
| Exercise trainingSupervised aerobic exercise intervention | Behavioural | 4 wk IMT + 12 wk exercise, 4 wk SHAM + 12 wk exercise |
Primary outcome
Change in exercise tolerance
Time frame: Baseline to 4 weeks
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Change in exercise tolerance
Time frame: Baseline to 16 weeks
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
10 secondary outcomes
Change in inspiratory muscle strength
Time frame: Baseline to 4 weeks
Change in inspiratory muscle strength
Time frame: Baseline to 16 weeks
Change in inspiratory muscle endurance
Time frame: Baseline to 4 weeks
Change in inspiratory muscle endurance
Time frame: Baseline to 16 weeks
Change in exercise capacity
Time frame: Baseline to 4 weeks
Change in exercise capacity
Time frame: Baseline to 16 weeks
Change in dyspnea
Time frame: Baseline to 4 weeks
Change in dyspnea
Time frame: Baseline to 16 weeks
Change in fatigue
Time frame: Baseline to 4 weeks
Change in fatigue
Time frame: Baseline to 16 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 17 Aug 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will make deidentified data freely available if requested. The privacy and rights of the participants will be protected.
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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.
Dharini M Bhammar, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training and Exercise training in people with Cancer Survivors and Obesity, run by Ohio State University Comprehensive Cancer Center 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 4 inclusion and 12 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 17 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
Change in exercise tolerance (time frame: Baseline to 4 weeks). The study lists 2 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 17 Aug 2026.