Respiratory Training for Lymphoma Survivors

Recruiting at 1 trial location

Overseen By Jared Scorsone

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Second cancer, Severe obesity, Diabetes, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

Trial Summary

What is the purpose of this trial?

High-resistance inspiratory muscle strength training (IMST) is a time-efficient (\~5 minutes/day) form of exercise that employs an affordable, handheld device which impedes inspiratory breathing to train the diaphragm and accessory respiratory muscles and has demonstrated improvements in both cardiovascular health (9 mmHg reduction in systolic blood pressure, 45% improvement in vascular endothelial function) and improve exercise tolerance (12% increase in treadmill exercise time) in generally healthy midlife/older adults. Therefore, this approach may circumvent preventative hurdles to exercise, and augment the effects of exercise for capable survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have recently changed your hypertensive medication, you may not be eligible to participate.

What data supports the effectiveness of the treatment Inspiratory Muscle Strength Training for lymphoma survivors?

Research shows that Inspiratory Muscle Training (IMT) can improve respiratory muscle strength and exercise capacity in patients with lung conditions, such as lung cancer and chronic obstructive pulmonary disease (COPD). This suggests that IMT might also help lymphoma survivors by strengthening their breathing muscles. ^{1 2 3 4 5}

Is inspiratory muscle training (IMT) safe for humans?

Research indicates that inspiratory muscle training (IMT) is generally safe for humans, including those with lung conditions and those requiring prolonged mechanical ventilation. Studies have explored its use in various settings without significant safety concerns. ^{1 2 3 4 6}

How is the respiratory training treatment for lymphoma survivors different from other treatments?

This treatment is unique because it focuses on strengthening the respiratory muscles through inspiratory muscle training (IMT), which is not a standard approach for lymphoma survivors. IMT has been used in other conditions like lung cancer and chronic obstructive pulmonary disease (COPD) to improve breathing and exercise capacity, but its application in lymphoma survivors is novel. ^{1 2 3 4 6}

Research Team

Ryan Marker, PT, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for lymphoma survivors aged 18-80 who've completed cancer treatment over a year ago, can exercise, and have a smartphone to use the training app. It's not for those with significant health issues like severe diabetes, heart disease, or unstable weight, nor for those doing lots of regular exercise already.

Inclusion Criteria

Provides a signed physician exercise clearance form

SBP > 120 mmHg

Able and willing to participate in a supervised exercise program at the Anschutz Health and Wellness Center

Exclusion Criteria

I haven't changed my blood pressure medication in the last 3 months.

I plan to start or change my cancer treatment within the next 6 months.

My BMI is either over 40 or under 18.5.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high-resistance inspiratory muscle strength training (IMST) and personalized exercise prescription

5 months

Regular sessions as per program adherence

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Inspiratory Muscle Strength Training
• Sham Inspiratory Muscle Strength Training

Trial Overview The study tests high-resistance inspiratory muscle strength training (IMST) using a handheld device against a sham version. IMST could improve cardiovascular health and exercise tolerance in just about 5 minutes per day.

Participant Groups

Group I: Lymphoma Survivors sham IMST Experimental Treatment 1 Intervention

Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.

Group II: Lymphoma Survivors IMST Experimental Treatment 1 Intervention

Participants will undergo a version of the BfitBwell Cancer Exercise Program physical assessment, which assesses physical fitness and function.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

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]

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 strength training (IMST) significantly increases maximal inspiratory pressure and reduces dyspnea in both older adults without COPD and those with COPD, demonstrating its efficacy as a respiratory intervention.

IMST particularly enhances functional status and quality of life in older adults without COPD, suggesting that this training can benefit a broader population beyond just COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. Huang, CH., Yang, GG., Wu, YT., et al.[2016]

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) did not show significant improvements in dyspnea, functional exercise capacity, or health-related quality of life in COPD patients, based on a review of 55 randomized controlled trials involving 4,467 participants.

However, IMT alone may lead to better outcomes in these areas, suggesting that while IMT can be beneficial, its effectiveness may be diminished when combined with PR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Ammous, O., Feki, W., Lotfi, T., et al.[2023]

Inspiratory muscle training (IMT) has been shown to significantly improve inspiratory muscle function, dyspnea, and health-related quality of life in patients with chronic obstructive pulmonary disease (COPD), based on a review of 15 randomized trials.

High-intensity IMT specifically enhances inspiratory muscle strength, but its effects on other clinical outcomes, such as exercise tolerance, remain unclear, indicating a need for further research to clarify these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with chronic obstructive pulmonary disease: the state of the evidence. Shoemaker, MJ., Donker, S., Lapoe, A.[2022]

A study involving 40 critically ill patients showed that using an electronic device for inspiratory muscle training (IMT) was feasible, with 81% of planned sessions completed, indicating good adherence to the intervention.

The electronic IMT was found to be safe, with no major adverse events and only 10% minor adverse events that were transient and without clinical consequences, while over 85% of participants reported it as helpful for their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and patient acceptability of electronic inspiratory muscle training in patients who require prolonged mechanical ventilation in the intensive care unit: A dual-centre observational study. Nickels, M., Erwin, K., McMurray, G., et al.[2023]

References

1. 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]

2. Germany 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. [2022]

3. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023]

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

Inspiratory muscle training in patients with chronic obstructive pulmonary disease: the state of the evidence. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and patient acceptability of electronic inspiratory muscle training in patients who require prolonged mechanical ventilation in the intensive care unit: A dual-centre observational study. [2023]