RECRUITING

Inspiratory Muscle Training in Obese Breast Cancer Survivors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer

Quick Facts

Study Start:2023-11-13

Study Completion:2029-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05193149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* functional limitations that make independent exercise unsafe * current smokers * 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

Inclusion Criteria

Exclusion 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

* functional limitations that make independent exercise unsafe
* current smokers
* 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

Contacts and Locations

Study Contact

Dharini M Bhammar, PhD

CONTACT

6143669467

dharini.bhammar@osumc.edu

Principal Investigator

Dharini M Bhammar, PhD

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

Dharini M Bhammar, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-13

Study Completion Date2029-06-30

Study Record Updates

Study Start Date2023-11-13

Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

Cancer Survivors
Obesity
Breast Cancer