Breast CancerNCT07229378
Respiratory Muscle Strength Training to Prevent Respiratory Muscle Weakness in Adults Newly Diagnosed With Breast Cancer
A study testing Respiratory muscle strength training and Guided Imagery Exercises in people with Breast Cancer, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Respiratory muscle strength training and Guided Imagery Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling adults (>18 years)
- Recently diagnosed with breast cancer
- Scheduled for breast cancer surgery
- English speaking, and can follow the protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Florida
Gainesville, Florida, 32610
Sandra P. Morgan, PhD, 239-898-2036, sandrakpoirier@ufl.edu
Barbara K. Smith, PhD, 352-294-5315, bksmith@PHHP.UFL.EDU
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Respiratory muscle strength training, Guided Imagery Exercises
- Keywords
- Respiratory muscle weakness, Breast Cancer, Breast Cancer Surgery, Respiratory strength training
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle strength trainingBehavioural
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 ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Guided Imagery Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2-4 weeks, and 2 weeks after surgery.
Secondary outcomes (6)
Change in Diaphragmatic thickness
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.
Measured: Baseline, 2-4 weeks, and 2 weeks after surgery
Change in Thoracic expansion
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.
Measured: Baseline, 2-4 weeks, and 2 weeks after surgery.
Change in Dyspnea
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.
Measured: Baseline, 2-4 weeks, and 2 weeks after surgery
Change in Anxiety and Depression
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.
Measured: Baseline, 2-4 weeks, and 2 weeks after surgery.
European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30)
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.
Measured: Baseline, 2-4 weeks, 2 weeks after surgery.
Six Minute Walk Test Distance
Standardized, functional capacity test by having the participant walk as far as possible on a flat, hard surface in six minutes.
Measured: Baseline, 2-4 weeks after the intervention, and 2 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startAug 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra K. Morgan, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229378
- Sponsor's protocol ID
- IRB202501485
- Status last verified
- Nov 2025
- First submitted
- 12 Nov 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that describe the results reported in this article, after the data is deidentified (tables, figures, and appendices).
Publications
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.
PubMed 29387634Nickels 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.
PubMed 37321882Nguyen 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.
PubMed 38782352Morton 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.
PubMed 29474837Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
PubMed 28186222Lumb AB. Pre-operative respiratory optimisation: an expert review. Anaesthesia. 2019 Jan;74 Suppl 1:43-48. doi: 10.1111/anae.14508.
PubMed 30604419Lovelace 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.
PubMed 31322834Ibrahim 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.
PubMed 38706507Gilliam 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.
PubMed 21171100Avudaiselvi 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.
PubMed 40860007Al-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.
PubMed 25504949
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Strength Training to Prevent Dyspnea in the Newly Diagnosed Breast Cancer Patient Prior to Surgery"
- ClinicalTrials.gov ID
- NCT07229378
- Acronym / sponsor ID
- IRB202501485
- Conditions
- Breast Cancer
- Keywords
- Respiratory muscle weakness, Breast Cancer, Breast Cancer Surgery, Respiratory strength training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Respiratory muscle strength training | Experimental | Behavioral: Respiratory muscle strength trainingParticipants 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. |
| Guided Imagery Exercises | Active comparator | Behavioral: Guided Imagery ExercisesParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Community-dwelling adults (>18 years)
- Recently diagnosed with breast cancer
- Scheduled for breast cancer surgery
- English speaking, and can follow the protocol
Key exclusion criteria (6 listed)
- Individuals who have already completed respiratory muscle strength training exercises
- Pregnancy,
- Recent pneumothorax
- Ruptured eardrum
- Uncontrolled hypertension, or uncontrolled reflux.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory muscle strength trainingAt 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. | Behavioural | Respiratory muscle strength training |
| Guided Imagery ExercisesGuided 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. | Behavioural | Guided Imagery Exercises |
Primary outcome
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.
6 secondary outcomes
Change in Diaphragmatic thickness
Time frame: Baseline, 2-4 weeks, and 2 weeks after surgery
Change in Thoracic expansion
Time frame: Baseline, 2-4 weeks, and 2 weeks after surgery.
Change in Dyspnea
Time frame: 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.
European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 29387634Quinn 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.
- Background: PubMed 37321882Nickels 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.
- Background: PubMed 38782352Nguyen 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.
- Background: PubMed 29474837Morton 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.
- Background: PubMed 28186222Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
- Background: PubMed 30604419Lumb AB. Pre-operative respiratory optimisation: an expert review. Anaesthesia. 2019 Jan;74 Suppl 1:43-48. doi: 10.1111/anae.14508.
- Background: PubMed 31322834Lovelace 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.
- Background: PubMed 38706507Ibrahim 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.
- Background: PubMed 21171100Gilliam 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.
- Background: PubMed 40860007Avudaiselvi 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.
- Background: PubMed 25504949Al-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.
- Individual participant dataSharing planned: Yes. Individual participant data that describe the results reported in this article, after the data is deidentified (tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra K. Morgan, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle strength training and Guided Imagery Exercises in people with Breast Cancer, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra P. Morgan, PhD (1-239-898-2036, sandrakpoirier@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal inspiratory pressure (time frame: Baseline, 2-4 weeks, and 2 weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229378, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.