Inspiratory Muscle Training for Breast Cancer Survivors with Obesity

(IMOCS Trial)

Overseen By Lisa Brenner

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Antibiotics, Steroids

Disqualifiers: Metastatic cancer, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 48

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a breathing exercise program can improve fitness levels in breast cancer survivors dealing with obesity. Participants will be divided into two groups: one will perform a specific breathing exercise called inspiratory muscle training, while the other will engage in a similar but less intense version. Both groups will also participate in aerobic exercises like walking or cycling. This trial suits breast cancer survivors who have completed treatment, have a BMI between 30 and 50, and find it challenging to be active. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance the quality of life for breast cancer survivors.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does allow participants who are on adjuvant endocrine therapy to join.

What prior data suggests that inspiratory muscle training is safe for breast cancer survivors with obesity?

Research has shown that inspiratory muscle training (IMT) is generally safe for breast cancer survivors, including those who are overweight. Studies have found that this training improves breathing and participants tolerate it well. No major reports of harmful side effects have emerged from using IMT in these groups.

Exercise training, often part of recovery for cancer survivors, is also considered safe. Research indicates that exercise improves physical abilities and reduces fatigue. Cancer survivors tolerate it well, and it is often recommended to enhance overall health and quality of life.

In summary, both inspiratory muscle training and exercise training are safe and beneficial for breast cancer survivors. Research supports their use without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about inspiratory muscle training (IMT) for breast cancer survivors with obesity because it targets respiratory muscles directly, unlike traditional options like general aerobic exercise or weight management programs. IMT uses a pressure threshold device to enhance lung strength and endurance, which can potentially improve overall fitness and quality of life for survivors. This approach is particularly promising because it addresses specific physical challenges faced by survivors, such as fatigue and reduced exercise capacity, in a way that standard exercise routines might not.

What evidence suggests that inspiratory muscle training is effective for improving exercise tolerance in obese breast cancer survivors?

Research has shown that inspiratory muscle training (IMT), which participants in this trial may receive, strengthens the muscles used for breathing and improves fitness in cancer survivors. Studies also find that IMT reduces symptoms like stress and tiredness and boosts physical ability, especially in those who are overweight. Exercise training, included in both treatment arms of this trial, enhances physical performance and reduces fatigue in breast cancer survivors. It also improves quality of life by boosting physical function and overall well-being. Together, IMT and exercise training might help breast cancer survivors who are overweight improve their exercise capacity. ^{1 3 4 5 6}

Who Is on the Research Team?

Dharini M Bhammar, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for sedentary obese breast cancer survivors with a BMI of 30-50, who finished treatment for Stage 0-III cancer within the past 6 months to 5 years. Participants should have some exercise intolerance but can't join if they smoke, are pregnant/nursing, or have heart disease, severe joint issues, recent infections treated with antibiotics or steroids, or any psychiatric conditions that affect study compliance.

Inclusion Criteria

I am currently on hormone therapy after my cancer treatment.

I finished treatment for early-stage breast cancer between 6 months and 5 years ago.

I am currently on hormone therapy for cancer.

Exclusion Criteria

You have a mental illness or social situation that would make it hard for you to follow the study rules.

I am currently fighting an infection and have recently taken antibiotics or steroids.

I do not have heart conditions that stop me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inspiratory Muscle Training (IMT) or SHAM

Participants undergo 4 weeks of either IMT or SHAM training, 3 times per week, with specific intensity levels using a pressure threshold device

4 weeks

12 visits (in-person)

Exercise Training

Participants engage in 12 weeks of aerobic exercise training including cycling, walking, and elliptical, starting in week 5, 3 times per week, up to 50 minutes per session at moderate intensity

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for changes in dyspnea, fatigue, exercise capacity, and inspiratory muscle strength and endurance

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise training
• Inspiratory muscle training

Trial Overview The trial is testing whether inspiratory muscle training improves exercise tolerance in these individuals compared to regular exercise training. It's a randomized controlled trial which means participants will be randomly assigned to one of the two interventions without choosing which one.

How Is the Trial Designed?

Group I: 4 wk IMT + 12 wk exercise Experimental Treatment 2 Interventions

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

Group II: 4 wk SHAM + 12 wk exercise Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

Two weeks of inspiratory muscle training (IMT) did not preserve respiratory muscle strength in high-risk patients undergoing lung cancer surgery, as measured by maximal inspiratory and expiratory pressures, but it did improve oxygen saturation levels postoperatively.

The incidence of pneumonia was similar between the IMT group and the control group, suggesting that IMT did not significantly reduce the risk of postoperative pulmonary complications, although it showed a trend towards better oxygenation on days 3 and 4 after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative inspiratory muscle training in addition to breathing exercises and early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized controlled trial. Brocki, BC., Andreasen, JJ., Langer, D., et al.[2022]

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) significantly improved respiratory muscle strength and exercise capacity in 20 patients with non-small cell lung cancer (NSCLC) undergoing radiotherapy, with no reported adverse events.

Key improvements were observed in maximum inspiratory muscle pressure, 6-minute walk test distance, cycle endurance test performance, and knee strength measurements after 4 weeks of training, indicating the potential benefits of IMT with PR for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training with pulmonary rehabilitation on NSCLC patients during radiation therapy: A pilot clinical study. Do, J., Lee, SH., Kim, SA., et al.[2023]

Inspiratory muscle training (IMT) significantly improves pulmonary function in cancer survivors, with a moderate effect size (standardized mean difference of 0.53) based on a systematic review and meta-analysis.

IMT is particularly beneficial for patients with oesophageal and lung cancers, especially when applied before biological treatment or after surgery, although it did not show significant effects on physical fitness or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer survivor inspiratory muscle training: systematic review and Bayesian meta-analysis. Tórtola-Navarro, A., Gallardo-Gómez, D., Álvarez-Barbosa, F., et al.[2022]

Inspiratory muscle training (IMT) significantly improved inspiratory muscle strength and walking distance in a group of 67 adults with obesity over a 4-week period, indicating its efficacy as a practical intervention.

The study suggests that IMT can enhance functional fitness in obese adults, potentially leading to increased participation in physical activities, making it a valuable self-administered strategy for home use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of inspiratory muscle training as a practical and minimally intrusive technique to aid functional fitness among adults with obesity. Edwards, AM., Graham, D., Bloxham, S., et al.[2018]

Inspiratory muscle training (IMT) combined with exercise significantly reduced symptoms of dyspnea during daily life in breast cancer survivors, with a notable improvement in the Transitional Dyspnea Index score by +2.9 points compared to the control group.

The IMT group also showed substantial enhancements in respiratory muscle endurance and cycling endurance, with increases of +472 seconds and +428 seconds, respectively, indicating that IMT may be an effective adjunctive rehabilitation tool for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive Inspiratory Muscle Training During a Rehabilitation Program in Patients With Breast Cancer: An Exploratory Double-Blind, Randomized, Controlled Pilot Study. Dahhak, A., Devoogdt, N., Langer, D.[2022]

Inspiratory muscle training (IMT) significantly improves physical capacity and inspiratory muscle strength in patients with obesity, as shown by a 44.5 m increase in the 6-minute walk test and a 28.4 cm H2O increase in maximal inspiratory pressure compared to controls.

Despite these improvements in physical capacity and muscle strength, IMT did not lead to significant changes in lung function, body mass index (BMI), or metabolic parameters, indicating that while IMT is beneficial for respiratory strength, it may not directly affect other obesity-related health metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with obesity: a systematic review and meta-analysis. Caicedo-Trujillo, S., Torres-Castro, R., Vasconcello-Castillo, L., et al.[2023]

Inspiratory muscle training (IMT) significantly improved inspiratory muscle strength and increased walking distance in a 6-minute walking test for overweight and obese adults, with a notable gain of 62.5 meters after 4 weeks of training.

The study involved 15 participants, and the results suggest that IMT could be a practical and effective preparatory strategy to enhance physical activity in overweight and obese individuals before starting a more intensive training program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four weeks of inspiratory muscle training improves self-paced walking performance in overweight and obese adults: a randomised controlled trial. Edwards, AM., Maguire, GP., Graham, D., et al.[2021]

A 12-week telemedicine-based intervention combining inspiratory muscle training (IMT) and walking promotion was found to be feasible and acceptable for lung cancer survivors, with a retention rate of 79% and high participant satisfaction.

Participants in the intervention group showed significant improvements in health-related quality of life (HRQL) compared to the control group, indicating that this approach may effectively disrupt the 'dyspnea-inactivity' spiral following lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. Ha, DM., Comer, A., Dollar, B., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9782413/

Impact of physical exercise programs in breast cancer ... Most training interventions provided an improvement in physical performance and a decrease in perceived fatigue. HRQoL was the outcome variable ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11184867/

Effectiveness of exercise modalities on breast cancer ... Overall exercise significantly improves the HRQOL, CRF and physical function in patients with BC. HRQOL was improved with all exercise types.

3. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-01634-6

Outcomes of physical exercises on initiation, progression, and ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325007152

Effect of physical exercise on the quality of life of women ... Women surviving breast cancer (WSBC) may experience reduced quality of life (QoL) due to disease-associated manifestations and undergone treatment.

5. bjsm.bmj.com bjsm.bmj.com/content/59/14/1010

Impact of exercise on health outcomes in people with cancer Conclusion Exercise reduces adverse events and enhances well-being through a range of health outcomes in people with cancer. Meta-analysis; Exercise; Randomised ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8576825/

Exercise Guidelines for Cancer Survivors - PubMed Central Results: Overall findings retained the conclusions that exercise training and testing was generally safe for cancer survivors and that every survivor should “ ...