Inspiratory Muscle Training in Obese Breast Cancer Survivors (IMOCS)

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The Ohio State University

Status

Enrolling

Conditions

Breast Cancer
Cancer Survivors
Obesity

Treatments

Behavioral: Inspiratory muscle training
Behavioral: Exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT05193149
OSU-22220

Details and patient eligibility

About

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.

Full 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).

Enrollment

78 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
  • current smokers
  • metastatic breast cancer
  • ongoing or active infection with recent antibiotics or steroids
  • 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

78 participants in 2 patient groups

4 wk IMT + 12 wk exercise
Experimental group
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
Treatment:
Behavioral: Exercise training
Behavioral: Inspiratory muscle training
4 wk SHAM + 12 wk exercise
Sham Comparator group
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
Treatment:
Behavioral: Exercise training

Trial contacts and locations

0

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Central trial contact

Dharini M Bhammar, PhD

Data sourced from clinicaltrials.gov

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