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

NCT07229378 | Not Yet Recruiting DMC

• 1 other identifier: IRB202501485
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Respiratory muscle weakness; Breast Cancer; Breast Cancer Surgery; Respiratory strength training

Outcome Measures

Primary Outcomes (1)

• Change in maximal inspiratory pressure

  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 Outcomes (6)

• Change in Diaphragmatic thickness

  Baseline, 2-4 weeks, and 2 weeks after surgery

• Change in Thoracic expansion

  Baseline, 2-4 weeks, and 2 weeks after surgery.

• Change in Dyspnea

  Baseline, 2-4 weeks, and 2 weeks after surgery

• Change in Anxiety and Depression

  Baseline, 2-4 weeks, and 2 weeks after surgery.

• European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30)

  Baseline, 2-4 weeks, 2 weeks after surgery.

Other Outcomes (4)

• Feasibility and acceptability

  Two weeks after surgery.

• Compliance with exercise diaries

  Through study completion, an average of one year.

• Retention Rates

  Through study completion, an average of one year.

Study Arms (2)

Respiratory muscle strength training

EXPERIMENTAL

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

Guided Imagery Exercises

ACTIVE COMPARATOR

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

Interventions

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.

Respiratory muscle strength training

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.

Guided Imagery Exercises

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (11)

• Quinn CJ, Hydock DS. Effects of endurance exercise and doxorubicin on skeletal muscle myogenic regulatory factor expression. Muscles Ligaments Tendons J. 2018 Jan 10;7(3):418-425. doi: 10.11138/mltj/2017.7.3.418. eCollection 2017 Jul-Sep.

  PMID: 29387634 BACKGROUND

• Nickels M, Erwin K, McMurray G, Talbot R, Strong M, Krishnan A, van Haren FMP, Bissett B. Feasibility, safety, and patient acceptability of electronic inspiratory muscle training in patients who require prolonged mechanical ventilation in the intensive care unit: A dual-centre observational study. Aust Crit Care. 2024 May;37(3):448-454. doi: 10.1016/j.aucc.2023.04.008. Epub 2023 Jun 14.

  PMID: 37321882 BACKGROUND

• Nguyen BL, Baumfalk DR, Lapierre-Nguyen SS, Zhong R, Doerr V, Montalvo RN, Wei-LaPierre L, Smuder AJ. Effects of exercise and doxorubicin on acute diaphragm neuromuscular transmission failure. Exp Neurol. 2024 Aug;378:114818. doi: 10.1016/j.expneurol.2024.114818. Epub 2024 May 21.

  PMID: 38782352 BACKGROUND

• Morton AB, Mor Huertas A, Hinkley JM, Ichinoseki-Sekine N, Christou DD, Smuder AJ. Mitochondrial accumulation of doxorubicin in cardiac and diaphragm muscle following exercise preconditioning. Mitochondrion. 2019 Mar;45:52-62. doi: 10.1016/j.mito.2018.02.005. Epub 2018 Feb 21.

  PMID: 29474837 BACKGROUND

• Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

  PMID: 28186222 BACKGROUND

• Lumb AB. Pre-operative respiratory optimisation: an expert review. Anaesthesia. 2019 Jan;74 Suppl 1:43-48. doi: 10.1111/anae.14508.

  PMID: 30604419 BACKGROUND

• Lovelace DL, McDaniel LR, Golden D. Long-Term Effects of Breast Cancer Surgery, Treatment, and Survivor Care. J Midwifery Womens Health. 2019 Nov;64(6):713-724. doi: 10.1111/jmwh.13012. Epub 2019 Jul 19.

  PMID: 31322834 BACKGROUND

• Ibrahim AA, Gabr Ali AMM, Fadulelmulla IA, Ragab MMM, Aldemery AA, Mohamed AR, Dewir IM, Hakami HA, Hussein HM. Using Inspiratory Muscle Training to Improve Respiratory Strength, Functional Capacity, Fatigue, and Stress in Breast Cancer Patients Undergoing Surgery. J Multidiscip Healthc. 2024 May 1;17:1931-1941. doi: 10.2147/JMDH.S463961. eCollection 2024.

  PMID: 38706507 BACKGROUND

• Gilliam LA, Moylan JS, Callahan LA, Sumandea MP, Reid MB. Doxorubicin causes diaphragm weakness in murine models of cancer chemotherapy. Muscle Nerve. 2011 Jan;43(1):94-102. doi: 10.1002/mus.21809.

  PMID: 21171100 BACKGROUND

• Avudaiselvi T, Prabha SL. Effectiveness of Box Breathing Exercises in Reducing Stress among Women Postmastectomy: A Randomized Controlled Trial. J Pharm Bioallied Sci. 2025 Apr-Jun;17(2):75-77. doi: 10.4103/jpbs.jpbs_888_25. Epub 2025 Jul 23.

  PMID: 40860007 BACKGROUND

• Al-Majid S, Wilson LD, Rakovski C, Coburn JW. Effects of exercise on biobehavioral outcomes of fatigue during cancer treatment: results of a feasibility study. Biol Res Nurs. 2015 Jan;17(1):40-8. doi: 10.1177/1099800414523489. Epub 2014 Feb 25.

  PMID: 25504949 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sandra K. Morgan, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra P. Morgan, PhD

CONTACT

1-239-898-2036; sandrakpoirier@ufl.edu

Barbara K. Smith, PhD

CONTACT

352-294-5315; bksmith@PHHP.UFL.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This research study is designed as a controlled, randomized, interventional trial for adults who have been diagnosed with breast cancer and are initiating breast cancer surgery. The feasibility, acceptability and strengthening effect of respiratory strength training exercises will be compared for effectiveness to a comparator group who will perform Guided Imagery exercises for at least ten sessions. This study design will examine which treatment is most beneficial in strengthening the respiratory musculature in preparation for breast cancer surgery.

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 17, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following study publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee.

Locations

US (1)