Respiratory Muscle Strength Training to Prevent Respiratory Muscle Weakness in Adults Newly Diagnosed With Breast Cancer

March 5, 2026 updated by: University of Florida

Respiratory Muscle Strength Training to Prevent Dyspnea in the Newly Diagnosed Breast Cancer Patient Prior to Surgery"

The goal of this clinical trial is to learn if respiratory muscle strength training can prevent respiratory muscle weakness in adults who are newly diagnosed with breast cancer and are planning to have surgery. The main question it aims to answer is:

  • Does respiratory muscle strength training in adults preparing for breast cancer surgery reduce the weakness that often occurs with surgery.

Researchers will compare Guided Imagery exercises to respiratory muscle strength training to see which is more helpful.

Participants will:

  • Carry out respiratory muscle strength training or Guided Imagery exercises for at least 2 weeks at home.
  • Meet with the researcher at home to complete breathing measurements before starting the exercises, after completing the exercises, and again after surgery.
  • Keep a diary of the exercises that have been completed.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction and Challenge: The therapies required to treat breast cancer can cause side effects such as muscle weakness and breathing problems. Surgery, chemotherapy, radiation, and some necessary breast cancer drug treatments can all contribute to a weakness in breathing function. Additionally, respiratory muscle strength and flexibility decrease in older adults as a part of the natural aging process. Unfortunately, the combination of breast cancer treatments with aging can contribute to an increase in breathing problems. Weakened breathing muscles and less chest wall flexibility leads to a decreased ability to complete normal daily activities, potentially causing increased anxiety and depression, and an overall decrease in quality of life.

Respiratory muscle strength training is an exercise that has been found to specifically focus on building the muscle strength and function of breathing. Respiratory muscle strength training is an exercise that is performed while sitting in a chair at home, for 15 minutes each day. The participant inhales into a handheld device that provides resistance during inhalation. Respiratory muscle strength training has been successfully used in other people with chronic illnesses, lung cancer, cardiac surgery, head and neck cancer, and patients preparing for surgery. Recently, it was trialed in a group of breast cancer patients after surgery, combined with aerobic exercises, with reports that the group that received respiratory muscle strength training had better outcomes. However, respiratory strength training has not yet been used on its own, as a preventative exercise before breast cancer surgery.

Methods and Action Plan: In this proposed study, the investigators plan to compare a group of newly diagnosed breast cancer patients who carry out daily respiratory muscle strength training exercises, to a group of newly diagnosed breast cancer patients who perform daily Guided Imagery. Guided Imagery has been found to improve anxiety and depression through the use of relaxing mental images designed to activate the body-mind connection. The researcher will carry out the study visits and teaching in the participant's home. The study equipment is portable, and the daily exercises can be done at home. This will help reduce the newly diagnosed breast cancer patient's burden of participating in this study. The investigator will measure respiratory strength, breathing function, diaphragm muscle thickness, chest mobility, anxiety and depression, and quality of life before and after the respiratory muscle strength training and the Guided Imagery protocols, and compare the results of the two groups. Each participant will be taught how to perform the assigned exercises, filling out exercise diaries, and talking by phone with the researcher each week for progress updates about the exercises, as well as how difficult they feel the exercises are.

Results and Main Findings: The investigators hypothesize that the individuals who perform the respiratory muscle strength exercises will find the respiratory strengthening protocol acceptable, and will have stronger breathing muscles, better breathing function, more chest mobility, thicker diaphragms, less anxiety and depression, and increased quality of life scores than those who performed deep breathing exercises, and that the Guided Imagery group may experience less anxiety and depression. The investigators anticipate that older breast cancer patients will benefit more than younger breast cancer patients after performing respiratory strength training.

Conclusion and Impact: This study will provide the opportunity to test whether respiratory strength training is acceptable to newly diagnosed breast cancer patients, and whether it protects and supports the breast cancer patient from respiratory weakness prior to surgery. These results will also allow the investigators to assess the impact of respiratory strength training on the older breast cancer patient. If successful, the next steps will include developing a larger clinical trial to test a diverse population to ensure the protocol is successful, before integrating this exercise into standard clinical practice for breast cancer patients.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandra P. Morgan, PhD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Community-dwelling adults (>18 years)
  • Recently diagnosed with breast cancer
  • Scheduled for breast cancer surgery
  • English speaking, and can follow the protocol

Exclusion Criteria:

  • Individuals who have already completed respiratory muscle strength training exercises
  • Pregnancy,
  • Recent pneumothorax
  • Ruptured eardrum
  • Uncontrolled hypertension, or uncontrolled reflux.
  • Individuals who cannot complete at least ten exercise sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Respiratory muscle strength training
Participants assigned to this arm will receive the equipment, education, and training to be able to perform respiratory muscle strength training for at least two weeks before breast cancer surgery.
Behavioral: Respiratory muscle strength training
At the baseline visit, participants will receive an inspiratory muscle strength trainer pre-set for 40% of their measured maximal inspiratory pressure, and respiratory exercise education using a teach back method in the form of demonstration, as well as written instructions. The respiratory strength exercises are to be performed five days/week for at least two weeks, for a total of 45 breaths each day. Inspiratory respiratory muscle strength training for at least two weeks has been shown to reduce respiratory complications because of surgery in other populations (Lumb, 2019). Respiratory resistance will be increased by 10% each week following an assessment using the modified Borg scale, if participants rate the perceived level of exertion ≤ 5 (Mahler & Horowitz, 1994). Exercise diaries and weekly follow-up phone calls will be used to monitor and document exercises.
Active Comparator: Guided Imagery Exercises
Participants assigned to this group will receive education and training to be able to perform Guided Imagery, an exercise that uses relaxing, calming mental images, for at least two weeks prior to breast cancer surgery. This exercise does not provide respiratory strengthening and will thus be used as a comparator to respiratory muscle strength training.
Behavioral: Guided Imagery Exercises
Guided Imagery, a relaxation technique that utilizes visualization to develop relaxing, peaceful images to help improve emotional health by reducing anxiety, and stress. At the baseline visit, participants will receive training to perform Guided Imagery techniques using a teach back method in the form of demonstration and return demonstration for the exercise technique, as well as written instructions. Exercise diaries and weekly follow-up phone calls will be used to monitor and document exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maximal inspiratory pressure
Time Frame: Baseline, 2-4 weeks, and 2 weeks after surgery.
Maximal inspiratory pressure (MIP) will be assessed as a measure of respiratory strength, using a respiratory pressure meter, a pocket-sized device that allows measures to be obtained with an accuracy of +/- 3%. Changes in MIP will be assessed at three timepoints.
Baseline, 2-4 weeks, and 2 weeks after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diaphragmatic thickness
Time Frame: Baseline, 2-4 weeks, and 2 weeks after surgery
Diaphragm thickness will be measured with a handheld ultrasound device to record diaphragm thickness and at both end-inspiration and end expiration. A change in diaphragmatic thickness will be assessed at each of the three timepoints.
Baseline, 2-4 weeks, and 2 weeks after surgery
Change in Thoracic expansion
Time Frame: Baseline, 2-4 weeks, and 2 weeks after surgery.
Thoracic expansion will be measured with a Gulick tape measure positioned around the participant's chest at the 4th intercostal space and will be used to record the difference between maximal inspiration and maximal expiration. The measures will be assessed at each of the three timepoints to assess for change over time.
Baseline, 2-4 weeks, and 2 weeks after surgery.
Change in Dyspnea
Time Frame: Baseline, 2-4 weeks, and 2 weeks after surgery
The Modified medical research council scale (MMRC) will be used to assess for a change in participants' dyspnea over the three timepoints. The MMRC scale includes a range of 0-4, with 4 being the most severe dyspnea.
Baseline, 2-4 weeks, and 2 weeks after surgery
Change in Anxiety and Depression
Time Frame: Baseline, 2-4 weeks, and 2 weeks after surgery.
The Hospital Anxiety and Depression scale (HADS) is a two subscale, 14-question scale with Likert-style responses focused on feelings of anxiety and depression. A higher score represents increasing severity of symptoms of anxiety and/or depression. A change in scores will be assessed at each of the three timepoints.
Baseline, 2-4 weeks, and 2 weeks after surgery.
European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30)
Time Frame: Baseline, 2-4 weeks, 2 weeks after surgery.
The EORTC QLQ-C30 is a 30-item instrument developed to measure quality of life in cancer patients. Higher scores on the functional subscales indicate better functioning, while higher scores on symptom subscales describe higher symptom burden. A change in EORTC QLQ-C30 will be assessed at each timepoint.
Baseline, 2-4 weeks, 2 weeks after surgery.
Six Minute Walk Test Distance
Time Frame: Baseline, 2-4 weeks after the intervention, and 2 weeks after surgery.
Standardized, functional capacity test by having the participant walk as far as possible on a flat, hard surface in six minutes.
Baseline, 2-4 weeks after the intervention, and 2 weeks after surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and acceptability
Time Frame: Two weeks after surgery.
Scores on a 6-question, Likert-style feasibility and acceptability questionnaire will be calculated, with higher scores indicating a higher participant perception of the feasibility and acceptability of the study.
Two weeks after surgery.
Compliance with exercise diaries
Time Frame: Through study completion, an average of one year.
Participant compliance with the exercise diaries will be assessed at the completion of the study and documented as a percentage. Higher scores will indicate stronger compliance.
Through study completion, an average of one year.
Compliance with weekly phone calls
Time Frame: Through study completion, an average of one year.
Compliance with weekly phone calls will be assessed at the end of the participant's study visits and reported as a percentage. Higher percentages indicate stronger compliance with phone calls
Through study completion, an average of one year.
Retention Rates
Time Frame: Through study completion, an average of one year.
Retention rates will be reported at the completion of the study in the form of a percentage. Higher scores indicate a higher rate of participant retention.
Through study completion, an average of one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Sandra K. Morgan, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 12, 2025

First Submitted That Met QC Criteria

November 12, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202501485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that describe the results reported in this article, after the data is deidentified (tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following study publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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