Breathing Muscle Training for Childhood Cancer Survivors

Overseen By Martina Miller

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Neuromuscular, Cardiac, Pulmonary, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a breathing exercise program can help childhood cancer survivors improve their breathing during exercise. Participants will use the POWERbreathe Plus device, a breathing muscle training tool, to train their breathing muscles at home for six weeks. The trial seeks survivors who completed cancer treatment over a year ago and do not have serious breathing or movement limitations. The goal is to make exercise easier and more comfortable by strengthening the muscles used for breathing. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance the quality of life for childhood cancer survivors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this breathing muscle training is safe for childhood cancer survivors?

Research shows that inspiratory muscle training (IMT), such as the POWERbreathe Plus device used in this trial, is generally safe. Studies have found that IMT involves no drugs and does not cause side effects or interfere with medications, making it a low-risk method to enhance breathing strength. Previous studies with hospital patients using similar devices for several weeks reported no major safety issues. With over 20 years of research supporting it, the POWERbreathe Plus has proven effective in reducing breathlessness without causing harm. This evidence suggests that the treatment is well-tolerated and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for childhood cancer survivors that often focus on medication and physical therapy, the POWERbreathe Plus IMT is a unique approach because it involves inspiratory muscle training, a specific type of breathing exercise. This device targets the strengthening of breathing muscles, potentially improving respiratory function more directly and efficiently than conventional methods. Researchers are excited about this non-invasive, home-based technique because it empowers patients to actively participate in their recovery, offering a personalized and convenient option that could enhance quality of life without the side effects associated with medications.

What evidence suggests that this inspiratory muscle training is effective for childhood cancer survivors?

Research shows that inspiratory muscle training (IMT), such as using the POWERbreathe Plus device, can help cancer survivors enhance lung function and physical fitness. One study found that using a device similar to the POWERbreathe Plus increased breathing muscle strength by 54% in just four weeks, significantly strengthening the muscles used for breathing. Although specific information about IMT for childhood cancer survivors is limited, these findings offer hope for improving breathing during exercise. Experts generally agree that strengthening these muscles can enhance overall fitness and quality of life. Participants in this trial will use the POWERbreathe Plus device for inspiratory muscle training to assess its effectiveness in childhood cancer survivors. ^{1 6 7 8 9}

Who Is on the Research Team?

Simon Ho

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for childhood cancer survivors who finished treatment (like chemo, surgery, or radiation) at least a year ago. It's not for those who had central nervous system cancers. Participants should be interested in improving their breathing muscles through training.

Inclusion Criteria

I finished my cancer treatment, except for brain cancer, over a year ago.

Exclusion Criteria

I had heart, lung, or muscle disease before my cancer diagnosis.

I've had an injury or condition within the last 6 months that stops me from doing strength tests or walking.

I get very short of breath with minimal activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline Assessment

Participants undergo pulmonary function and muscle performance tests followed by treadmill walking trials with expired gas analysis

1 visit

1 visit (in-person)

Treatment

Participants perform inspiratory muscle training at home for 6 weeks with weekly telehealth follow-ups

6 weeks

6 visits (virtual)

Follow-up

Participants return for a follow-up visit to undergo the same assessments as the baseline visit

1 visit

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• POWERbreathe Plus IMT

Trial Overview

The study tests the POWERbreathe Plus IMT device to see if it helps with breathing muscle strength and how well participants can regulate their breath during exercise after surviving cancer in childhood.

How Is the Trial Designed?

Group I: Inspiratory Muscle Training (IMT) Experimental Treatment 1 Intervention

Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home.

POWERbreathe Plus IMT is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as POWERbreathe Plus for:

• Asthma
• COPD
• Bronchitis
• Cystic Fibrosis
• Heart Failure
• Spinal Injury
• Respiratory Conditions

Approved in United States as POWERbreathe Plus for:

• Asthma
• COPD
• Bronchitis
• Cystic Fibrosis
• Heart Failure
• Spinal Injury
• Respiratory Conditions

Approved in Canada as POWERbreathe Plus for:

• Asthma
• COPD
• Bronchitis
• Cystic Fibrosis
• Heart Failure
• Spinal Injury
• Respiratory Conditions

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

Inspiratory muscle training (IMT) appears to be safe for children aged 5-18 with neuromuscular diseases, as no adverse events were reported in the reviewed studies involving 168 participants.

While IMT did not show significant improvements in pulmonary function tests, it did lead to notable enhancements in inspiratory muscle strength and endurance, indicating potential benefits for respiratory health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training for children and adolescents with neuromuscular diseases: A systematic review. Human, A., Corten, L., Jelsma, J., 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) has been shown to improve inspiratory muscle function in patients with chronic obstructive pulmonary disease (COPD), with most studies indicating positive effects when proper training methods are used.

IMT can lead to significant clinical benefits, including reduced dyspnea and increased exercise capacity, as evidenced by improved walking distances in 6 or 12-minute tests, particularly when using a threshold device at an intermediate load for at least 5 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training in patients with chronic obstructive pulmonary disease]. Lisboa, C., Borzone, G., Cruz, E.[2006]

Inspiratory muscle training (IMT) significantly improved muscle strength and peak expiratory flow (PEF) in children with asthma, with MIP increasing from -48.32 to -109.92 and PEF from 173.6 to 312, indicating enhanced respiratory function.

In contrast, the control group showed no significant improvements in muscle strength, highlighting the efficacy of IMT and respiratory exercises in reducing asthma severity and improving respiratory muscle efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training and respiratory exercises in children with asthma. Lima, EV., Lima, WL., Nobre, A., et al.[2019]

Inspiratory muscle rehabilitation training (IMRT) has been shown to significantly improve respiratory muscle strength, endurance, and exercise performance in pediatric patients with chronic lung disease, indicating its potential efficacy in this population.

Despite its benefits, IMRT is underutilized in pediatric care, and there is a need for more standardized training protocols and larger randomized controlled trials to strengthen the evidence supporting its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Rehabilitation Training in Pediatrics: What Is the Evidence? Bhammar, DM., Jones, HN., Lang, JE.[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 improved inspiratory strength and lung function in young swimmers, with notable increases in the S-Index and maximum inspiratory flow after a four-week program.

Swimmers who underwent IMT showed significantly faster swimming times in 50-m, 100-m, and 200-m events compared to a control group, indicating that enhanced respiratory muscle strength positively impacts swimming performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. Yañez-Sepulveda, R., Alvear-Ordenes, I., Tapia-Guajardo, A., et al.[2021]

In a study involving 12 normal subjects, the Powerbreathe inspiratory muscle trainer showed a significant improvement in maximal static inspiratory mouth pressure, but no significant difference in diaphragm strength or other respiratory measures after 6 weeks of training.

The results suggest that the Powerbreathe device does not provide sufficient evidence to justify its continued sale and use, highlighting the need for larger studies to confirm its efficacy in improving diaphragm strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an inspiratory muscle trainer in healthy humans. Hart, N., Sylvester, K., Ward, S., et al.[2004]

Inspiratory muscle training (IMT) significantly improves balance in both healthy and diseased adults, based on a systematic review of 10 randomized control trials.

The effects of IMT on functional mobility were inconclusive, indicating that while balance benefits are clear, more research is needed to understand its impact on overall mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. Sheraz, S., Ferraro, FV., Siddiqui, FA., et al.[2023]

In a study of 22 premature infants over 2 weeks, respiratory training using inspiratory flow-resistive loads significantly improved respiratory muscle endurance by 137% in the trained group, while the control group showed no improvement.

The trained infants also experienced a decrease in baseline breathing frequency and a lesser increase in inspiratory time under load, indicating enhanced respiratory efficiency, although there was no significant change in respiratory muscle strength between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of respiratory training with inspiratory flow resistive loads in premature infants. Tan, S., Duara, S., Silva Neto, G., et al.[2007]

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