Respiratory Training for Lymphoma Survivors

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a simple breathing exercise can improve heart health and fitness in lymphoma survivors. Participants will use a small device for about 5 minutes daily to strengthen their breathing muscles through Inspiratory Muscle Strength Training (IMST). The trial will compare this training to a sham (inactive) version to assess its effectiveness. Individuals who completed lymphoma treatment over a year ago and have a smartphone may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery and quality of life for lymphoma 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 prior data suggests that this respiratory training device is safe for lymphoma survivors?

Research has shown that inspiratory muscle training (IMT) is generally safe for individuals, including those with lung issues and those requiring long-term breathing support. Studies have found that IMT can help prevent muscle weakness and may reduce the likelihood of needing a breathing tube. For cancer survivors, it might also help lessen shortness of breath. Overall, evidence suggests that IMT is well-tolerated and could be a safe option for lymphoma survivors seeking to improve their breathing health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Respiratory Training for Lymphoma Survivors trial because it explores a novel approach to improving the quality of life for those who have battled lymphoma. Unlike traditional treatments that focus primarily on chemotherapy and radiation, this trial examines the potential benefits of Inspiratory Muscle Strength Training (IMST). IMST is unique because it targets the respiratory muscles directly, which may enhance physical fitness and function by improving breathing efficiency and overall lung health. This approach could offer a non-invasive and potentially more accessible method to help lymphoma survivors regain strength and stamina, setting it apart from more invasive or medication-based treatments.

What evidence suggests that this respiratory training is effective for lymphoma survivors?

Research has shown that inspiratory muscle strength training (IMST) can improve health in lymphoma survivors. Studies have found that IMST strengthens breathing muscles and reduces shortness of breath in older adults, even those without conditions like COPD. It also helps people exercise longer, with a 12% increase in treadmill time observed in healthy older adults. For cancer survivors, IMST may enhance lung function and overall fitness. Additionally, a review of several studies found that IMST boosts quality of life and physical fitness in cancer survivors. These benefits make IMST a promising way to enhance the health of lymphoma survivors. In this trial, participants will join either the IMST group or the Sham IMST group to evaluate the effectiveness of these interventions. ^{1 2 3 6 7}

Who Is on the Research Team?

Ryan Marker, PT, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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

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

SBP > 120 mmHg

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.

Unstable weight (> 3 kg change in body mass in last 3 months)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05938127

Impact of Respiratory Training in Lymphoma Survivors High-resistance inspiratory muscle strength training (IMST) is a time-efficient (~5 minutes/day) form of exercise that employs an affordable, ...

2. withpower.com withpower.com/trial/phase-lymphoma-11-2023-2c315

Respiratory Training for Lymphoma Survivors Inspiratory muscle strength training (IMST) significantly increases maximal inspiratory pressure and reduces dyspnea in both older adults without COPD and those ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11092410/

Potential Therapeutic Role of Respiratory Muscle Training in ... Preliminary evidence supports the potential of respiratory muscle training to reduce dyspnea in cancer survivors, although large randomized controlled studies ...

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

5. researchgate.net researchgate.net/publication/317025266_Respiratory_Muscle_Training_Improves_Exercise_Performance_and_Quality_of_Life_in_Cancer_Survivors_A_Pilot_Study

Respiratory Muscle Training Improves Exercise ... Therefore, the results of this study suggest that IMT has a high persistence rate and is highly effective for patients with advanced lung cancer ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29282152/

Safety and efficacy of inspiratory muscle training for ... Inspiratory muscle training was a protective factor against endotracheal intubation, muscle weakness, and mortality.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/1759-7714.15272

Safety and efficacy evaluation of personalized exercise ... Rehabilitation exercises using individualized exercise prescriptions tailored by exercise prescription specialists during chemotherapy are safe for lung cancer ...