Inspiratory Muscle Training for Breast Cancer Survivors with Obesity
(IMOCS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University
Must not be taking: Antibiotics, Steroids
Disqualifiers: Metastatic cancer, Heart disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese 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 data supports the effectiveness of this treatment for breast cancer survivors with obesity?
Inspiratory muscle training (IMT) has been shown to improve respiratory function and physical fitness in cancer survivors, as well as reduce symptoms like shortness of breath in breast cancer survivors when combined with exercise programs.
12345Is inspiratory muscle training safe for humans?
Inspiratory muscle training (IMT) has been studied in various groups, including cancer survivors and adults with obesity, and is generally considered safe. It is often used alongside other exercises to improve breathing and physical fitness without significant safety concerns.
12346How is inspiratory muscle training different from other treatments for breast cancer survivors with obesity?
Inspiratory muscle training (IMT) is unique because it specifically targets the muscles used for breathing, helping to reduce breathlessness and improve physical performance, which can be particularly beneficial for breast cancer survivors with obesity. Unlike other treatments that may focus on weight loss or general fitness, IMT directly enhances respiratory muscle strength, making it a practical and minimally intrusive option.
12678Eligibility Criteria
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.
+5 more
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.
+9 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 4 wk IMT + 12 wk exerciseExperimental Treatment2 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 exercisePlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State UniversityColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State UniversityLead Sponsor
Ohio State University Comprehensive Cancer CenterLead Sponsor
References
The effects of inspiratory muscle training with pulmonary rehabilitation on NSCLC patients during radiation therapy: A pilot clinical study. [2023]The effects of inspiratory muscle training (IMT) with pulmonary rehabilitation (PR) on patients with non-small cell lung cancer (NSCLC) receiving radiotherapy (RT) have not previously been reported. This pilot study aimed to determine the effectiveness of IMT with PR on respiratory muscles and exercise capacity of NSCLC patients receiving RT.
Adjunctive Inspiratory Muscle Training During a Rehabilitation Program in Patients With Breast Cancer: An Exploratory Double-Blind, Randomized, Controlled Pilot Study. [2022]To investigate whether inspiratory muscle training (IMT) offered adjunctively to an exercise training program reduces symptoms of dyspnea in survivors of breast cancer.
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. [2022]The aim was to investigate whether 2 weeks of inspiratory muscle training (IMT) could preserve respiratory muscle strength in high-risk patients referred for pulmonary resection on the suspicion of or confirmed lung cancer. Secondarily, we investigated the effect of the intervention on the incidence of postoperative pulmonary complications.
Cancer survivor inspiratory muscle training: systematic review and Bayesian meta-analysis. [2022]The long-term impact of cancer treatment is associated with respiratory dysfunction and physical fitness impairment. Although inspiratory muscle training (IMT) has been shown as an effective exercise therapy in cancer survivors, there is no evidence on the optimal dose, application moment nor specific population effects of this intervention. The main objective of this meta-analysis is to analyse the effects of IMT on pulmonary function, physical fitness and quality of life (QoL) in cancer survivors.
Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. [2023]Following curative-intent therapy of lung cancer, many survivors experience dyspnea and physical inactivity. We investigated the feasibility, acceptability, safety, and potential efficacy of inspiratory muscle training (IMT) and walking promotion to disrupt a postulated "dyspnea-inactivity" spiral.
Efficacy of inspiratory muscle training as a practical and minimally intrusive technique to aid functional fitness among adults with obesity. [2018]To examine the efficacy of inspiratory muscle training (IMT) as a non-intrusive and practical intervention to stimulate improved functional fitness in adults with obesity. As excess adiposity of the chest impedes the mechanics of breathing, targeted re-training of the inspiratory muscles may ameliorate sensations of breathlessness, improve physical performance and lead to greater engagement in physical activity.
Four weeks of inspiratory muscle training improves self-paced walking performance in overweight and obese adults: a randomised controlled trial. [2021]Objective. To examine whether a programme of inspiratory muscle training (IMT) improves accumulative distance of self-paced walking in overweight and obese adults. Methods. A total of 15 overweight and obese adults were randomized into experimental (EXP: n = 8) and placebo (PLA: n = 7) groups. Lung function, inspiratory muscle performance, 6-minute walking test, and predicted [Formula: see text]O(2) max were assessed prior to and following the 4-week IMT intervention. Both groups performed 30 inspiratory breaths, twice daily using a proprietary inspiratory resistance device set to 55% of baseline maximal effort (EXP), or performing the same inspiratory training procedure at the minimum resistive setting (PLA). Results. Lung function was unchanged in both groups after-training; however inspiratory muscle strength was significantly improved in EXP (19 ± 25.2 cm H(2)O gain; P
Inspiratory muscle training in patients with obesity: a systematic review and meta-analysis. [2023]Obesity is a chronic medical condition that affects, among others, the cardiovascular and respiratory systems. Interventions for its treatment focus on sustained weight reduction and general health improvement, leaving respiratory management aside. Our objective was to determine the effects of inspiratory muscle training (IMT) in patients with obesity.