Inspiratory Muscle Training in Obese Breast Cancer Survivors

NCT05193149 | Recruiting

• 1 other identifier: OSU-22220
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Breast Cancer; Cancer Survivors

Outcome Measures

Primary Outcomes (2)

• Change in exercise tolerance

  Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.

  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.

  Baseline to 16 weeks

Secondary Outcomes (10)

• Change in inspiratory muscle strength

  Baseline to 4 weeks

• Change in inspiratory muscle strength

  Baseline to 16 weeks

• Change in inspiratory muscle endurance

  Baseline to 4 weeks

• Change in inspiratory muscle endurance

  Baseline to 16 weeks

• Change in exercise capacity

  Baseline to 4 weeks

Study Arms (2)

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

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

Behavioral: Exercise training

Interventions

Inspiratory muscle training BEHAVIORAL

Training of respiratory muscles

4 wk IMT + 12 wk exercise

Exercise training BEHAVIORAL

Supervised aerobic exercise intervention

4 wk IMT + 12 wk exercise; 4 wk SHAM + 12 wk exercise

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Obesity; Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dharini M Bhammar, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dharini M Bhammar, PhD

CONTACT

6143669467; dharini.bhammar@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Staff completing outcomes testing and study participants will be blinded to treatment assignment (IMT/SHAM). The IMT/SHAM devices are the same with ability to alter resistance; however, upon use at the lower intensity, the participant may be able to tell whether the device has resistance.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 14, 2022
• Study Start: November 13, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available after data collection is complete for up to 3 years.
• Access Criteria: Deidentified data will be made available on request following approved data use agreements between institutions.

Locations

US (1)