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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days, 1,3month
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days, 1,3month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days, 1,3month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global muscle strength
Mobility status
Muscle mass
Secondary outcome measures
Stay in the ICU and hospital
Time on the ventilator or ECMO
Side effects data
From 2016 Phase 4 trial • 8 Patients • NCT0183389738%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS 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
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.
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,586 Total Patients Enrolled
Irina TimoftePrincipal Investigator - University of Maryland
Baltimore VA Medical Center, University of Maryland Medical Center, University of Maryland Medical Center Midtown Campus
University De Medical Si Farm (Medical School)
Huron Hospital (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe lung disease but can't have a transplant due to other health issues.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.
Research Study Groups:
This trial has the following groups:- Group 1: Transplant Control Group
- Group 2: Transplant
- Group 3: ECMO- Bridge to Transplant
- Group 4: ECMO- Bridge to Transplant Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available slots in this research project for participants?
"This study, which was first posted on January 13th 2019, is not enrolling patients at the moment according to clinicaltrials.gov. Although, there are 327 other clinical trials that are still recruiting patients."
Answered by AI
Does this research involve individuals who are above the age of 25?
"The age limit for this study is 80 years old. Any patients who meet this age criteria and are above the age of 18 are eligible to participate."
Answered by AI
I am interested in enrolling myself in this research, what are the next steps?
"This study is looking for 70 patients who have lung disease and are between 18 and 80 years old. In order to be eligible, patients must also meet the following criteria:-Advanced lung disease requiring ECMO bridge to lung transplantation-Patient or legally authorized representative are able to provide written or witnessed verbal consent-Advanced lung disease requiring lung transplantation"
Answered by AI
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