Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease

NCT03562728 | Active Not Recruiting DMC

• 1 other identifier: HP-00080970
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Lung Disease; Lung Transplant; Extracorporeal Membrane Oxygenation

Keywords

Transplant; ECMO; Sarcopenia; Deconditioning; Physical therapy

Outcome Measures

Primary Outcomes (3)

• Global muscle strength

  Muscle group strength is obtained using hand held dynamometer

  14 days

• Mobility status

  Mobility status is assessed with 6 minute walk distance

  14 days

• Muscle mass

  Muscle mass measurement of lower extremity muscle volume using ultrasound scan or computer tomography

  14 days,

Secondary Outcomes (2)

• Time on the ventilator or ECMO

  14 days, 1 month

• Stay in the ICU and hospital

  14 days, 1,3month

Study Arms (4)

ECMO- Bridge to Transplant

ACTIVE COMPARATOR

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.

Device: MRP and NMES(neuromuscular electric stimulation)

ECMO- Bridge to Transplant Control Group

OTHER

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

Other: Standard of Care

Transplant

ACTIVE COMPARATOR

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.

Device: MRP and NMES(neuromuscular electric stimulation)

Transplant Control Group

OTHER

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

Other: Standard of Care

Interventions

MRP and NMES(neuromuscular electric stimulation) DEVICE

nutrition supplementation includes addition of essential amino acids 3 times a day to feeding

Also known as: Dietary Supplement(NS)

ECMO- Bridge to Transplant; Transplant

Standard of Care OTHER

Patients in the control group are going to receive standard of care

ECMO- Bridge to Transplant Control Group; Transplant Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced lung disease requiring lung transplantation
• Advanced lung disease requiring ECMO bridge to lung transplantation
• Patient or legally authorized representative are able to provide written or witnessed verbal consent.

You may not qualify if:

• Unable to obtain consent from patient or family member
• Advanced lung disease but not transplant candidate due to other comorbidities
• Patient is deemed unsafe for rehabilitation by the transplant physician

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (7)

• Downs AM. Physical therapy in lung transplantation. Phys Ther. 1996 Jun;76(6):626-42. doi: 10.1093/ptj/76.6.626.

  PMID: 8650277 BACKGROUND

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 BACKGROUND

• Vogiatzis I, Terzis G, Nanas S, Stratakos G, Simoes DC, Georgiadou O, Zakynthinos S, Roussos C. Skeletal muscle adaptations to interval training in patients with advanced COPD. Chest. 2005 Dec;128(6):3838-45. doi: 10.1378/chest.128.6.3838.

  PMID: 16354852 BACKGROUND

• Williams TJ, Patterson GA, McClean PA, Zamel N, Maurer JR. Maximal exercise testing in single and double lung transplant recipients. Am Rev Respir Dis. 1992 Jan;145(1):101-5. doi: 10.1164/ajrccm/145.1.101.

  PMID: 1731570 BACKGROUND

• Vogiatzis I, Nanas S, Roussos C. Interval training as an alternative modality to continuous exercise in patients with COPD. Eur Respir J. 2002 Jul;20(1):12-9. doi: 10.1183/09031936.02.01152001.

  PMID: 12166558 BACKGROUND

• Chambers DC, Yusen RD, Cherikh WS, Goldfarb SB, Kucheryavaya AY, Khusch K, Levvey BJ, Lund LH, Meiser B, Rossano JW, Stehlik J; International Society for Heart and Lung Transplantation. The Registry of the International Society for Heart and Lung Transplantation: Thirty-fourth Adult Lung And Heart-Lung Transplantation Report-2017; Focus Theme: Allograft ischemic time. J Heart Lung Transplant. 2017 Oct;36(10):1047-1059. doi: 10.1016/j.healun.2017.07.016. Epub 2017 Jul 19. No abstract available.

  PMID: 28784324 BACKGROUND

• Alon G, V Smith G. Tolerance and conditioning to neuro-muscular electrical stimulation within and between sessions and gender. J Sports Sci Med. 2005 Dec 1;4(4):395-405. eCollection 2005 Dec.

  PMID: 24501553 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Irina Timofte

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 19, 2018
• Study Start: January 13, 2019
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)