Preoperative Inspiratory Muscle Training

NCT04423614 | Withdrawn

• 2 other identifiers: IRB202001038OCR35362
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In light of the corona virus pandemic (COVID-19), there is critical need to conserve scarce mechanical ventilation (MV) resources. This study evaluates an intervention in non-infected cardiac patients as a means to assist with minimizing MV and ICU length of stay (LOS). Pre-op inspiratory muscle training (IMT) has been shown to decrease pulmonary complications, MV dependence, and ICU LOS following thoracic surgery. The investigators aim to determine the mechanism of remodeling in diaphragms of adults who undergo pre-op IMT.

Conditions

Mechanical Ventilation Complication

Keywords

Mechanical ventilation; Inspiratory muscle training; Difficulty weaning from mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• Maximal inspiratory pressure

  Maximal inspiratory pressure will be quantified in cm of water pressure.

  Post breathing exercise sessions (up to 4 weeks)

• Muscle fiber cross-sectional area and fiber type proportion.

  Histology will be used to determine fiber type and cross-sectional area using primary antibodies for laminin and type-specific myosin heavy chain, followed by a triple immunofluorescence-conjugated secondary antibody labeling technique.

  Intra-operatively

Secondary Outcomes (8)

• Peak expiratory flow

  Post breathing exercise sessions (up to 4 weeks)

• Time to extubation

  Up to discharge from ICU

• Length of ICU stay

  Up to 1 month

• Length of hospital stay

  Up to 1 month

• Neuromuscular junction morphology

  Intra-operatively

Study Arms (2)

Inspiratory Muscle Training (IMT)

EXPERIMENTAL

Pre-operative inspiratory muscle training

Other: Inspiratory Muscle Training

Relaxation Breathing (RLX)

EXPERIMENTAL

Relaxation breathing exercises

Other: Relaxation Breathing

Interventions

Inspiratory Muscle Training OTHER

Inspiratory muscle training exercises, performed 5 times a week for 2-4 weeks prior to cardiac surgery.

Inspiratory Muscle Training (IMT)

Relaxation Breathing OTHER

Relaxation breathing exercises, performed 5 times a week for 2-4 weeks prior to cardiac surgery.

Relaxation Breathing (RLX)

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac surgery candidate
• Ability to complete pre-operative breathing exercises

You may not qualify if:

• Surgery is scheduled in less than 2 weeks
• New York Heart Association Class III or IV Cardiac Disease
• History of hemiparesis
• History of spinal cord injury
• History of progressive neuromuscular disease that may interfere with the ability to complete study interventions
• Previous cardiothoracic surgery within the last 12 weeks
• History of pneumonectomy
• History of lung surgery
• History of skeletal pathology (e.g. scoliosis) that may interfere with chest wall movements
• Routine usage of muscle relaxants, immunosuppressants, or corticosteroid medications within the past 30 days
• Forced expiratory volume 1 less than 40% of age-predicted value
• Presence of active malignancy
• Presence of any organ dysfunction that may limit ability to participate in seated respiratory exercises

Sponsors & Collaborators

• University of Florida: lead

Study Officials

• Barbara Smith, PhD, PT

  University of Florida

  PRINCIPAL INVESTIGATOR

• Thomas Beaver, MD, MPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized into one of two arms. In Arm 1, subjects will perform pre-operative inspiratory muscle training. In Arm 2, subjects will perform pre-operative relaxation breathing. A diaphragm biopsy will be taken during surgery for both arms and the tissue will be compared. In addition, a biopsy of the pectoralis major will be obtained from each subject and serve as a non-exercised control which will compared to the subject's diaphragm muscle biopsy (which participated in the intervention).

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: December 1, 2021
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01