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

Trial Summary

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 data supports the effectiveness of the treatment POWERbreathe Plus IMT for childhood cancer survivors?

Research shows that inspiratory muscle training (IMT) can improve the strength and endurance of breathing muscles, reduce feelings of breathlessness, and enhance exercise performance in children. This suggests that similar benefits might be seen in childhood cancer survivors using POWERbreathe devices. ^{1 2 3 4 5}

Is inspiratory muscle training safe for children and adults?

Research on inspiratory muscle training (IMT) in children with neuromuscular diseases and adults with chronic obstructive pulmonary disease (COPD) shows that it is generally safe, with no reported adverse events in these studies. ^{1 2 6 7 8}

How does the treatment POWERbreathe Plus IMT differ from other treatments for childhood cancer survivors?

POWERbreathe Plus IMT is unique because it focuses on strengthening the breathing muscles through resistance training, which can improve respiratory muscle strength and endurance. This approach is different from other treatments that may not specifically target the respiratory muscles, and it can enhance exercise capacity and quality of life, especially in pediatric populations. ^{1 2 5 9 10}

What is the purpose of this trial?

The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in childhood cancer survivors.

Research Team

Simon Ho

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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 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 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]

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]

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) 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]

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]

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]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Rehabilitation Training in Pediatrics: What Is the Evidence? [2022]

2. Singapore pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training with pulmonary rehabilitation on NSCLC patients during radiation therapy: A pilot clinical study. [2023]

3. United States 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. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training and respiratory exercises in children with asthma. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training for children and adolescents with neuromuscular diseases: A systematic review. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of an inspiratory muscle trainer in healthy humans. [2004]

8. Chile pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training in patients with chronic obstructive pulmonary disease]. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

The effects of respiratory training with inspiratory flow resistive loads in premature infants. [2007]

10. Italy pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. [2021]