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NCT Number: NCT07229378

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory muscle strength training

Behavioral

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.

Guided Imagery Exercises

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara K. Smith, PhD

CONTACT

[email protected]

352-294-5315

Sandra P. Morgan, PhD

CONTACT

[email protected]

1-239-898-2036

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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