Progressive Rehabilitation Therapy for Advanced Lung Disease

Recruiting in Palo Alto (17 mi)

Overseen byIrina Timofte

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Maryland, Baltimore

No Placebo Group

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.

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

Treatment Details

Interventions

MRP (Behavioural Intervention)
NMES (Behavioural Intervention)

Trial OverviewThe 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

4Treatment groups

Experimental Treatment

Active Control

Group I: Transplant Control GroupExperimental Treatment1 Intervention

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

Group II: ECMO- Bridge to Transplant Control GroupExperimental Treatment1 Intervention

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

Group III: TransplantActive Control1 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 TransplantActive Control1 Intervention