13 Participants Needed

Breathing Muscle Training for Childhood Cancer Survivors

MM
Overseen ByMartina Miller
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Maryland, Baltimore
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.16789

Who Is on the Research Team?

SH

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?
1Treatment groups
Experimental Treatment
Group I: Inspiratory Muscle Training (IMT)Experimental Treatment1 Intervention

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

🇪🇺
Approved in European Union as POWERbreathe Plus for:
🇺🇸
Approved in United States as POWERbreathe Plus for:
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Approved in Canada as POWERbreathe Plus for:

Find a Clinic Near You

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

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36216456/
Cancer survivor inspiratory muscle training: systematic ...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.
Safety and efficacy of inspiratory muscle training for ...Powerbreathe® Plus model linear inspiratory resistor ... Table 3 Data on adverse outcomes and adverse events by intervention group in the followed hospitalised ...
The use of respiratory muscle training in patients with ...Little is known about clinical efficacy of RMT in cancer patients. Conflicting results have been reported regarding increases in respiratory muscle strength ...
POWERbreathe in Research 2020-2029 ArchivesA randomized clinical trial: immediate respiratory warm-up effect on dynamic inspiratory muscle strength in cardiac surgery candidates.
Inspiratory Muscle Training Program Using the PowerBreathPowerBreath® administering a ≥ 15% resistive load of the maximum inspiratory pressure (PIM) achieves significant improvements (54%) in said pressure within 4 ...
Safety and efficacy of inspiratory muscle training for ...Patients in the inspiratory muscle training group performed 4 weeks of inspiratory muscle training using a Powerbreathe® Plus model linear ...
Efficacy of Inspiratory Muscle Training on Respiratory ...POWER breath Plus: Provides a variable level of load setting (weight lifted) in increments of 16/17cmH2O, from 23cmH2O to 186cmH2O; ...
8.powerbreathe.compowerbreathe.com/
POWERbreathe | The World's No.1 Breathing TrainerPOWERbreathe IMT is drug-free with no side effects or drug interactions and is clinically proven to alleviate breathlessness. 20 years of validation. We have ...
The Safety and Efficacy of Inspiratory Muscle Training for ...Our study is designed to evaluate the feasibility of IMT and its effectiveness in improving inspiratory muscle strength in participants with AMI who have ...
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