Clinical trial · Interventional
Inspiratory Muscle Training in Obese Breast Cancer Survivors
Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer
NCT05193149CI-TRIAL-00122342IMOCScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer Survivors | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise training | Behavioral | — | UNRESOLVED |
| Inspiratory muscle training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 4 wk IMT + 12 wk exercise
- description
- 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
- interventionNames
- Behavioral: Inspiratory muscle training
- Behavioral: Exercise training
- type
- SHAM_COMPARATOR
- label
- 4 wk SHAM + 12 wk exercise
- description
- 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
- interventionNames
- Behavioral: Exercise training
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.