Exercise Rehabilitation in Patients With Severe Cardiopulmonary Dysfunction on Extracorporeal Life Support

NCT06792617 | Enrolling By Invitation Early Phase 1 FDA Device

• 1 other identifier: ERECLS-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Short-term and long-term consequences of severe cardiac and/or lung dysfunction can be increased use of sedation, prolonged bedrest and immobility causing severe loss of muscle mass which could be a risk for muscle weakness, osteoporosis, and lowered endurance. The goal of this study is to show how a structured rehabilitation program can exhibit better short-term and long-term outcomes on patients who are treated with extracorporeal membrane oxygenation (ECMO).

Conditions

ExtraCorporeal Membrane Oxygenation (ECMO); Cardiopulmonary Function; Rehabilitation

Keywords

Extracorporeal membrane oxygenation (ECMO); Rehabilitation exercise program

Outcome Measures

Primary Outcomes (1)

• Timing of exercises

  Time spent exercising per each session of rehabilitation program

  From enrollment to 3-month follow-up

Secondary Outcomes (8)

• Mobility

  From enrollment to 3-month follow-up

• Mobility

  From enrollment to 3-month follow-up

• Mobility

  From enrollment to 3-month follow-up

• Mobility

  From enrollment to 3-month follow-up

• Mobility

  From enrollment to 3-month follow-up

Other Outcomes (1)

• Quality of Life (QOL)

  From enrollment to 3-month follow-up

Study Arms (1)

Exercise Group

OTHER

The exercise group will complete the highest intensity exercise and activity as tolerated to maximize their progression of strength, function, and out of bed. This group will also be utlizing the VitalGo Total Lift Bed (TLB) V5 for vertical positioning to provide a better potential for hemodynamic response to activities to include: strength training, mobility tasks, and functional activities like Activities of Daily Living (ADL).

Other: Mobility (Central or Femoral Cannulation); Other: Resistance Training

Interventions

Mobility (Central or Femoral Cannulation) OTHER

Functional Mobility \& ADL's 1. Assisted sitting with progression to unassisted; ADL's 2. Assisted standing with progression to unassisted; ADL's 1. VitalGo bed will be used if unsafe/unable to perform assisted standing. 2. Leg press (VitalGo bed) 3. Ambulation; ADL's

Exercise Group

Resistance Training OTHER

Repetitions will be counted and documented per session per structured exercise.

Exercise Group

Eligibility Criteria

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

You may qualify if:

• Age \>or equal to 18 years old
• On ECMO (VV and/or VA) for cardiopulmonary dysfunction/failure
• Admitted to Lung Recovery Intensive Care Unit (LRICU) or Cardiovascular Intensive Care Unit (CVICU).
• Richmond Agitation and Sedation Scale (RASS) greater than or equal to a score of -2 or greater.

You may not qualify if:

• Hemodynamically unstable as determined by clinical care team (including but not limited to: oxygen saturation \<90%, below target range of mean arterial pressure despite vasoactive or mechanical support, prone positioning, use of mechanical assist device (such as the intra-aortic balloon pump \[IABP\] or ventricular assist device \[VAD\]), active management of intracranial hypertension with abnormal intracranial pressure, spinal precautions, uncontrolled seizures, unstable major fracture, large open surgical wound, known controlled active bleeding).
• Unable to utilize the VitalGo Total Lift BedTM (TLB, Catalog No. V5, Miramar FL) (e.g., height restrictions \[\>228 cm\], weight restrictions \[\>425 lbs\])
• Pregnant or breast feeding.
• Anticipated transfer to another hospital within 72 hours.
• Not anticipated to survive more than 24 hours.
• Unable to obtain informed consent from either patient or legally authorized representative (LAR).
• Patients in the ICU but not on ECMO upon enrollment.
• Patients actively awaiting transplant (heart/lung) without potential for weaning from ECMO.

Sponsors & Collaborators

• Institute for Extracorporeal Life Support: lead

Study Sites (1)

Methodist Healthcare System

San Antonio, Texas, 78229, United States

Location

Related Publications (7)

• Kang D, Lim J, Kim BG, Nam H, Kim Y, Kang E, Kim S, Shim S, Lee M, Yoon J, Lee H, Shin SH, Park HY, Cho J. Psychometric validation of the Korean Patient-Reported Outcome Measurement Information System (PROMIS)-29 Profile V2.1 among patients with chronic pulmonary diseases. J Thorac Dis. 2021 Oct;13(10):5752-5764. doi: 10.21037/jtd-21-591.

  PMID: 34795924 BACKGROUND

• Fisher CJ, Namas R, Seelman D, Jaafar S, Homer K, Wilhalme H, Young A, Nagaraja V, White ES, Schiopu E, Flaherty K, Khanna D. Reliability, construct validity and responsiveness to change of the PROMIS-29 in systemic sclerosis-associated interstitial lung disease. Clin Exp Rheumatol. 2019 Jul-Aug;37 Suppl 119(4):49-56. Epub 2019 Sep 4.

  PMID: 31498073 BACKGROUND

• Eggmann S, Verra ML, Luder G, Takala J, Jakob SM. Effects of early, combined endurance and resistance training in mechanically ventilated, critically ill patients: A randomised controlled trial. PLoS One. 2018 Nov 14;13(11):e0207428. doi: 10.1371/journal.pone.0207428. eCollection 2018.

  PMID: 30427933 BACKGROUND

• Hayes K, Holland AE, Pellegrino VA, Young M, Paul E, Hodgson CL. Early rehabilitation during extracorporeal membrane oxygenation has minimal impact on physiological parameters: A pilot randomised controlled trial. Aust Crit Care. 2021 May;34(3):217-225. doi: 10.1016/j.aucc.2020.07.008. Epub 2020 Oct 7.

  PMID: 33039302 BACKGROUND

• Hayes K, Holland AE, Pellegrino VA, Mathur S, Hodgson CL. Acute skeletal muscle wasting and relation to physical function in patients requiring extracorporeal membrane oxygenation (ECMO). J Crit Care. 2018 Dec;48:1-8. doi: 10.1016/j.jcrc.2018.08.002. Epub 2018 Aug 7.

  PMID: 30118978 BACKGROUND

• Batycka-Stachnik D, Piwoda A, Darocha T, Spiewak M, Kosinski S, Jarosz A, Hymczak H, Sanak T, Galazkowski R, Piatek J, Konstanty-Kalandyk J, Drwila R. Problems and challenges in the early period of rehabilitating patients with severe hypothermia treated using ecmo support. Wiad Lek. 2016;69(3 pt 2):489-494.

  PMID: 27717931 BACKGROUND

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 BACKGROUND

MeSH Terms

Interventions

Range of Motion, Articular; Multicenter Studies as Topic; Resistance Training

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement

Study Officials

• Linda E Sousse, PhD, MBA

  Institute for Extracorporeal Life Support

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: The investigators will conduct a prospective clinical trial on eligible adults (≥18 years) with severe cardiac and/or lung dysfunction placed on ECMO. Results will be compared to historical controls from MHS who have not been enrolled in a rehabilitation program, which is the current standard of care (SOC).

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 24, 2025
• Study Start: October 25, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)