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Behavioural Intervention

Progressive Rehabilitation Therapy for Advanced Lung Disease

N/A

Waitlist Available

Led By Irina Timofte

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Advanced lung disease requiring lung transplantation

Advanced lung disease requiring ECMO bridge to lung transplantation

Must not have

Advanced lung disease but not transplant candidate due to other comorbidities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days, 1,3month

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the role of physical therapy in patients with advanced lung disease who require transplant or ECMO.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from NMES, fatigue from exercise programs, and possible nutritional supplement intolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need a lung transplant due to advanced lung disease.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days, 1,3month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days, 1,3month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days, 1,3month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global muscle strength

Mobility status

Muscle mass

Secondary study objectives

Stay in the ICU and hospital

Time on the ventilator or ECMO

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897

38%

sedation

25%

headache

13%

phosphenes

13%

hypomania

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine and DCS Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 3Eligibility criteria met