Weathering the Storm: Lung, Heart, and Brain Vascular Rehabilitation for COVID-19

NCT04887272 | Unknown

• 2 other identifiers: 2021-0185UL1TR002003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Respiratory and cardiovascular complications have emerged as dominant threats during and following coronavirus disease (COVID19) infection. Severe COVID19 infection is categorized as acute respiratory dysfunction leading to hospitalization, where as a mild infection is identified as symptoms of dyspnea, muscle pains, migraines, palpitations and/or fatigue persisting for several weeks. Recovery from COVID19 infection is poorly characterized, but symptoms appear to gradually decline over a four to eight-week period. Unfortunately, recovery from severe infection is similar to symptoms experienced with mild infection making it rather difficult to provide a physiological definition of recovery for mild infection sufferers. Considering that 81% of COVID19 infections are found to be mild, approximately 4.5 million Americans may be vulnerable to inadequate cardiovascular recovery that exacerbates reductions in physical capacity and quality of life. Combined respiratory muscle and exercise training enhance cardiorespiratory function, maximize return to activities of daily living, and reduces hospitalization times in heart failure, sepsis and severe acute respiratory syndrome. However, it is unclear if these interventions will also enhance cardiorespiratory and cerebrovascular COVID19 recovery. Therefore, utilizing cardiorespiratory and cerebrovascular rehabilitation techniques we propose these specific research aims and hypotheses to investigate the following:

1. 1.Does individualized cardiac exercise rehabilitation enhance cardiorespiratory \& cerebrovascular recovery?
2. 2.Individualized exercise therapy designed to increase fitness will enhance cardiorespiratory function at rest, as well as during and following exercise in individuals recovering from COVID19.
3. 3.Cerebrovascular function at rest, as well as during and following exercise will be enhanced following individualized exercise therapy in individuals recovering from COVID19 infection.
4. 4.The magnitude of post-training cardiorespiratory enhancements will be associated with cerebrovascular adaptations in individuals recovering from COVID19 infection.
5. 5.Does combining inspiratory muscle and cardiac exercise rehabilitation provide additive cardiorespiratory and cerebrovascular COVID19 recovery benefits?
6. 6.The addition of inspiratory muscle training to individualized exercise therapy will enhance cardiorespiratory adaptation in individuals recovering from COVID19 infection.
7. 7.Improved cardiorespiratory function associated with inspiratory muscle training and exercise therapy will add further recovery advantage to cerebrovascular function in individuals recovering from COVID19 infection.

Conditions

Covid19

Keywords

Cerebral Blood Flow; Exercise

Outcome Measures

Primary Outcomes (3)

• Cerebrovascular Function

  Change in cerebral artery vasodilatory capacity and stiffness using transcranial and vascular duplex ultrasound in individuals previously infected with COVID19 following six weeks of exercise training or exercise and inspiratory muscle training.

  week 0 and week 7

• Cardiopulmonary Fitness

  Change in cardiopulmonary fitness using incremental maximal exercise and measures of oxygen consumption in individuals previously infected with COVID19 following six weeks of exercise training or exercise and inspiratory muscle training.

  week 0 and week 7

• Inspiratory Muscle Function

  Change in inspiratory muscle function using tests of incremental respirayory endurance in individuals previously infected with COVID19 following six weeks of exercise training or exercise and inspiratory muscle training.

  Week 1 and Week 6

Secondary Outcomes (3)

• Cerebrovascular metaboreflex

  week 0 and week 7

• Cardiac mechanics

  week 0 and week 7

• Peripheral artery function

  Week 0 and 7

Study Arms (2)

Exercise Training (EXT)

ACTIVE COMPARATOR

Research participants will complete six weeks of supervised progressive aerobic and resistance exercise training (EXT). Cardiopulmonary, cerebral and peripheral vascular function will be measured pre and post EXT.

Other: Supervised Exercise Training Protocol

Inspiratory Muscle and Exercise Training (IMET)

EXPERIMENTAL

Research participants will complete six weeks of supervised aerobic and resistance exercise training in addition to supervised respiratory muscle training (IMET). IMET sessions will be performed similar to EXT, with the exception of having sessions of at-home IMT training. On these days, all training will be spread out over a 2-hour session with periods of IMT training occurring at the beginning, middle, and end of the session. Cardiopulmonary, cerebral and peripheral vascular function will be measured pre and post IMET.

Other: Supervised Exercise Training Protocol; Other: Inspiratory Muscle and Exercise Training

Interventions

Supervised Exercise Training Protocol OTHER

EXT: Supervised EXT will include a progressive individualized program that combines aerobic and resistance protocols. Volume progression will begin with 3-days of supervised training sessions/wk and will increase by 1 session/wk to a maximum of 5-days/wk. Each EXT session will include 30 minutes of aerobic training (15 minutes cycling; 15 minutes treadmill walking/running/elliptical) and 30 minutes of resistance training (specifics below). Considering individual fatigue will be a concern, therefore similar to exercise training standards in COPD, the duration of rest periods may be extended (\~1-3 min) as needed, however, all exercise durations will be completed within a 1.5-hour time slot. On days that EXT and IMET interventions overlap, the training and IMET will be spread out over a 2-hour session as opposed to the 1.5-hour time slot.

Also known as: EXT

Exercise Training (EXT); Inspiratory Muscle and Exercise Training (IMET)

Inspiratory Muscle and Exercise Training OTHER

Inspiratory Muscle Training (IMT): All IMT sessions will be performed similar to EXT, with the exception of having 2-3-sessions of at-home IMT training depending on where in the exercise progression the individual is (i.e., Week1 vs week 6). On the days that IMT and exercise training overlap, all training will be spread out over a 2-hour session with periods of IMT training occurring at the beginning, middle and end of the session. Each week will include a measure of Maximal Inspiratory Pressure (MIP) and a Test of Inspiratory Respiratory Endurance (TIRE). The intensity of the IMT will be 50% of the weekly MIP, thus progressive increases in IMT threshold intensity will remain at 50% of the weekly MIP. In contrast, the TIRE protocol will assess respiratory endurance based on the relative baseline intensity. Thus TIRE testing will begin at a MIP intensity of 50% (weeks 1-2), and then progressing to 65% (weeks 3-4), and 80% (weeks 5-6).

Also known as: IMET

Inspiratory Muscle and Exercise Training (IMET)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI\<40,
• weeks post active COVID19 infection
• physician approval for undertaking exercise testing and training.
• Adequate intracranial ultrasound windows

You may not qualify if:

• Lingering COVID19 symptomology
• cardiovascular disease
• pulmonary disease
• cerebrovascular disease
• taking medication that influences heart rate, blood pressure, or cerebrovascular function,
• severe obesity (BMI \>40)
• metabolic comorbidities (diabetes, metabolic syndrome),
• recently been diagnosed with a mild traumatic brain injury (within past 6 months).

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

COVID-19; Motor Activity

Interventions

Exercise; histaminol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kurt Smith, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurt Smith, PhD

CONTACT

312-996-1858; k2jsmith@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data analysis assessor will be blinded to pre and post-testing samples, as well as to the treatment group.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: May 14, 2021
• Study Start: May 15, 2021
• Primary Completion: August 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

US (1)