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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Institute for Extracorporeal Life Support
Study ID
NCT06792617
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

  • Cardiopulmonary Function
  • ExtraCorporeal Membrane Oxygenation (ECMO)
  • Rehabilitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • Resistance Training — OTHER
    Repetitions will be counted and documented per session per structured exercise.

Study Details

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).

Key Dates

Start date
Oct 25, 2024
Status verified
Jan 2025
Primary completion
May 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Exercise Group
    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).

Primary Outcome Measure

Timing of exercises [ Time Frame: From enrollment to 3-month follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
Methodist Healthcare SystemSan AntonioTexas78229-

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By research site
Methodist Healthcare System· San Antonio, TX

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