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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The International Society of Heart and Lung Transplantation Registry data shows that there is a growing population of critically ill patients with advanced lung disease undergoing lung transplantation. The goal of our study is to evaluate the role of intensive physical therapy for patients with advanced lung disease requiring transplant or ECMO(extracorporeal membrane oxygenation)- bridge to transplant with emphasis on the restoration of functional independence and prevention of functional declines after lung transplantation. The project is a designed as a randomized prospective research study investigating the impact of a multi-modal rehabilitation program(MRP), which incorporates neuromuscular electric stimulation(NMES), strength and mobility training, and nutritional supplementation(NS) in ameliorating the loss of muscle mass and strength, and lower extremity balance, strength and coordination that will decrease time on the ventilator or ECMO, stay in the ICU and hospital.

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 MRP, NMES, Neuromuscular Electrical Stimulation for advanced lung disease?

Research shows that neuromuscular electrical stimulation (NMES) can improve muscle strength and endurance in people with severe chronic obstructive pulmonary disease (COPD), which is a type of advanced lung disease. This suggests that NMES might help improve physical function in patients with advanced lung conditions. ^{1 2 3 4 5}

Is neuromuscular electrical stimulation (NMES) safe for humans?

Neuromuscular electrical stimulation (NMES) has been used safely in people with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), even during acute exacerbations, without affecting adherence or clinical outcomes. It is considered a low-burden exercise modality that can be continued safely in these conditions. ^{2 6 7 8 9}

How is the treatment MRP, NMES different from other treatments for advanced lung disease?

This treatment is unique because it uses neuromuscular electrical stimulation (NMES) to help improve muscle function and walking endurance in patients with severe lung disease, especially those who cannot tolerate traditional exercise programs. Unlike standard pulmonary rehabilitation, NMES can be used as a localized training method, making it suitable for patients with severe limitations. ^{1 2 4 10 11}

Research Team

Irina Timofte

Principal Investigator

University of Maryland

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of neuromuscular electrical stimulation combined with early rehabilitation therapy on mechanically ventilated patients: a prospective randomized controlled study. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Denmark pubmed.ncbi.nlm.nih.gov

[Neuromuscular electrical stimulation improves the functional level in patients with severe chronic obstructive pulmonary disease]. [2019]

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

Home-based Neuromuscular Electrical Stimulation as an Add-on to Pulmonary Rehabilitation Does Not Provide Further Benefits in Patients With Chronic Obstructive Pulmonary Disease: A Multicenter Randomized Trial. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Effects of home-based neuromuscular electrical stimulation in severe chronic obstructive pulmonary disease patients: a randomized controlled clinical trial. [2018]

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

Neuromuscular electrical stimulation prevents muscle function deterioration in exacerbated COPD: a pilot study. [2022]

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

Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Impact of mild-to-moderate exacerbations on outcomes of neuromuscular electrical stimulation (NMES) in patients with COPD. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of neuromuscular electrical stimulation in patients with COPD followed in intensive care unit. [2022]

10. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of the effects of neuromuscular electrical stimulation and endurance training in patients with severe chronic obstructive pulmonary disease. [2019]

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

Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. [2022]