Progressive Rehabilitation Therapy for Advanced Lung Disease

Overseen By Avelino Verceles, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Other comorbidities, Unsafe for rehab

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how intensive physical therapy can assist people with advanced lung disease who need a lung transplant or use ECMO (a machine that supports heart and lung function) as a bridge to transplant. The study will determine if a special rehab program, which includes muscle exercises, electric stimulation (Neuromuscular Electrical Stimulation or NMES), and nutrition supplements, can improve muscle strength and balance, and reduce time on machines and in the hospital. The trial is open to those with advanced lung disease who are candidates for lung transplants or ECMO. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could enhance future treatment options.

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 rehabilitation program is safe for patients with advanced lung disease?

Research has shown that intensive physical therapy is generally safe for people awaiting a lung transplant. Studies have found that patients with serious lung problems can safely engage in supervised exercise. This therapy helps maintain exercise capacity and physical function before the transplant.

Regarding neuromuscular electric stimulation (NMES), which uses gentle electrical signals to make muscles contract, studies suggest it is safe and practical for those preparing for lung transplants. NMES has safely boosted muscle strength without causing serious side effects.

Overall, these findings suggest that both intensive physical therapy and NMES are well-tolerated options for people with advanced lung conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Progressive Rehabilitation Therapy for advanced lung disease because it combines physical therapy with neuromuscular electric stimulation (NMES) to enhance muscle strength and function. Unlike standard treatments that focus primarily on medication and oxygen therapy, this approach actively engages muscles using weak electric impulses, stimulating muscle groups like the quadriceps and dorsiflexors. Additionally, the therapy includes nutrition supplementation with essential amino acids to prevent muscle breakdown and support a positive nitrogen balance, which isn't typically part of standard care. These innovative features could significantly improve patients' physical capabilities and overall quality of life.

What evidence suggests that this trial's treatments could be effective for advanced lung disease?

This trial will evaluate the effects of combining progressive rehabilitation therapy with neuromuscular electric stimulation (NMES) for patients with severe lung disease. Participants in the treatment arms will receive NMES, which studies have shown can boost exercise ability and strengthen muscles, particularly the quadriceps. This is crucial for patients waiting for or recovering from lung transplants, as stronger muscles can aid in faster recovery. Additional evidence suggests that NMES, along with physical exercises, may also enhance lung function and oxygen use. Moreover, nutritional supplements provided in the treatment arms help prevent muscle loss, which is vital for these patients. Overall, these methods aim to speed up recovery by reducing the time spent on ventilators and in the ICU. ^{1 6 7 8 9}

Who Is on the Research Team?

Irina Timofte

Principal Investigator

University of Maryland

Are You a Good Fit for This Trial?

This trial is for patients with severe lung disease who need a lung transplant or ECMO (a life-support technique) as a bridge to transplantation. They must be able to give consent themselves or through a legal representative, and safe for rehabilitation as per their doctor.

Inclusion Criteria

Patient or legally authorized representative are able to provide written or witnessed verbal consent.

I need a lung transplant due to advanced lung disease.

I need a machine to help my lungs work until I can get a lung transplant.

Exclusion Criteria

Unable to obtain consent from patient or family member

I have severe lung disease but can't have a transplant due to other health issues.

Patient is deemed unsafe for rehabilitation by the transplant physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Assessment

Initial global assessment of functional capabilities after listing for lung transplantation and within 72 hours after cardio-thoracic procedure

1 week

1 visit (in-person)

Treatment

Participants receive a multi-modal rehabilitation program including neuromuscular electric stimulation, strength and mobility training, and nutritional supplementation

4 weeks

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of mobility status, muscle strength, and muscle mass

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRP
• NMES

Trial Overview

The study tests an intensive physical therapy program called MRP, which includes neuromuscular electric stimulation (NMES), strength training, mobility exercises, and nutritional support. It's compared against the standard care to see if it helps reduce muscle loss and improves recovery times.

How Is the Trial Designed?

Group I: Transplant Control Group Experimental Treatment 1 Intervention

Interventions: standard of care. Patients are not going to receive any additional intervention.

Group II: ECMO- Bridge to Transplant Control Group Experimental Treatment 1 Intervention

Interventions: standard of care Patients are not going to receive any additional intervention.

Group III: Transplant Active Control 1 Intervention

Interventions: MRP+MNES(neuromuscular electric stimulation).Patients in the treatment arm will receive additional physical therapy(arm and leg exercises, using light weight machines, hand weights, or rubber bands, exercise machines such as portable arm or seated bikes) as well as therapy with an electric stimulator device. This device uses weak electric impulses to involuntarily exercise the muscles(one-two sessions a day).Four muscle groups(quadriceps and dorsiflexors bilaterally) will be stimulated using surface electrodes .In addition, patients in the experimental group will receive nutrition supplementation with essential amino acids 3 times a day in their feeding to prevent muscle breakdown and promote positive nitrogen balance.

Group IV: ECMO- Bridge to Transplant Active Control 1 Intervention

Interventions: MRP+MNES(neuromuscular electric stimulation).Patients in the treatment arm will receive additional physical therapy(arm and leg exercises, using light weight machines, hand weights, or rubber bands, exercise machines such as portable arm or seated bikes) as well as therapy with an electric stimulator device. This device uses weak electric impulses to involuntarily exercise the muscles(one-two sessions a day).Four muscle groups(quadriceps and dorsiflexors bilaterally) will be stimulated using surface electrodes .In addition, patients in the experimental group will receive nutrition supplementation with essential amino acids 3 times a day in their feeding to prevent muscle breakdown and promote positive nitrogen balance.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

In a randomized controlled trial involving 22 patients with severe COPD, neuromuscular electrical stimulation (NMES) significantly improved quadriceps strength by 14% and endurance by 42% compared to a control group.

Despite the improvements in muscle function, NMES did not enhance walking endurance, indicating that while it can strengthen muscles, it may not directly translate to better walking performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation appears to be useful in people with severe chronic obstructive pulmonary disease. Gerovasili, V.[2012]

In a study involving 20 patients with advanced COPD, neuromuscular electrical stimulation (NMES) significantly improved muscle cross-sectional area, strength, and endurance compared to sham training, indicating its efficacy in enhancing muscle function.

The improvements in walking distance after NMES were linked to increased muscle strength and a better balance between muscle growth and breakdown, suggesting that NMES positively affects muscle metabolism in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Vivodtzev, I., Debigaré, R., Gagnon, P., et al.[2022]

Neuromuscular electrical stimulation (NMES) has been shown to significantly improve muscle strength and endurance in patients with severe chronic obstructive pulmonary disease (COPD), based on multiple randomized trials.

However, NMES does not appear to provide the same benefits for patients with moderate COPD, suggesting that its use should be specifically targeted to those with more advanced disease in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neuromuscular electrical stimulation improves the functional level in patients with severe chronic obstructive pulmonary disease]. Al-Gibouri, S., Ringbæk, T., Lange, P.[2019]

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FULL TEXT

In this study, we assessed the effects of pulmonary rehabilitation before lung transplant on exercise capacity, functional mobility, and quality ...

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Virtual Physical Prehabilitation in Lung Transplant Candidates

This study aimed to preliminary test the effectiveness of 12-week virtual physical prehabilitation program followed by a maintenance phase.