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Cardiopulmonary Rehabilitation in COVID-19 Longhaulers

Primary Purpose

Covid19, Viral Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Treadmill Exercise

Concentrated Oxygen

Concentrated Air

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Post-COVID Syndrome, Post-acute COVID, Long COVID

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Between the ages of 18-60
Contracted COVID-19 between February - July 2020
Has been clinician-diagnosed with COVID-19 based on PCR/antigen testing, antibody testing, or clinical symptoms
Is currently experiencing one or more of the following symptoms, which began only after contracting COVID-19 : dyspnea, cough, chest pain, tachycardia or other arrhythmias, hypertension, hypotension, blood pressure lability, oxygen desaturation, exercise/activity intolerance, fatigue, or dizziness.
Has been cleared by a physician for exercise and supplemental oxygen.
Has the capacity to provide written, informed consent
Able to complete questionnaires in English

Exclusion Criteria:

History of any of the following per the American College of Sports Medicine exercise testing guidelines (American College of Sports Medicine et al., 2018) to be determined during a screening consultation:
1. Acute myocardial infarction within the past two days
2. Ongoing unstable angina
3. Uncontrolled cardiac arrhythmias
4. Active endocarditis
5. Symptomatic severe aortic stenosis
6. Decompensated heart failure
7. Active pulmonary embolism, pulmonary infarction, or deep venous thrombosis
8. Active myocarditis or pericarditis
9. Acute aortic dissection
10. Physical disability that precludes safe and adequate testing
Participants who demonstrate orthostatic intolerance or oxygen desaturation (<90%) during the exercise tolerance test will no longer be eligible for the study because it is not safe for them to exercise on a treadmill.

Sites / Locations

Post-COVID Rehabilitation and Recovery Clinic at H&D Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Placebo Comparator

Arm Label

Treadmill Exercise with Supplemental Oxygen

Treadmill Exercise with Air

Supplemental Oxygen Only

No Intervention

Arm Description

Participants will receive 24 sessions (2 x week for 12 weeks) of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes.

Participants will receive 8 sessions (2 x week for 4 weeks) of treadmill exercise combined with air delivered via nasal cannula during exercise and 5-minutes of recovery. They will then cross-over to 16 sessions of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes.

Participants will receive 8 treatment sessions (2 x week for 4 weeks) of 6 liters per minute of continuous oxygen via nasal cannula for 30 minutes at rest. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three minutes. They will then cross-over to 16 sessions of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes.

Participants will receive 8 treatment sessions (2 x week for 4 weeks) of air via nasal cannula for 30 minutes at rest. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three minutes. They will then cross-over to 16 sessions of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes.

Outcomes

Primary Outcome Measures

Heart rate and rhythm response to exercise and positional changes

Heart rate and rhythm will be measured using 3-lead ECG telemetry

Blood pressure response to exercise and positional changes

Blood pressure will be measured via manual cuff

Activity metabolic equivalent of task (MET) tolerated

MET will be computed based upon peak exercise speed (MPH) and incline % gradation). Scores are expected to range from 1.8 to 12.1 (but can be higher is speed exceeds 3.9 MPH). Higher METs indicate more energy output.

Breathlessness

Breathlessness will be assessed during peak exercise via self-report using the Borg Dyspnea scale. Scores can range from 0 to 20 and higher scores indicate more breathlessness

Rate of perceived exertion (RPE)

RPE will be assessed during peak exercise via self-report using the Borg RPE scale. Scores can range from 0 to 20 and higher scores indicate more RPE.

Cognition (attention, short, delayed, and working memory, verbal fluency, and abstraction).

Cognition will be assessed with the Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS-U) List Learning, List Recall, List Recognition, Story Memory, Story Recall, Semantic Fluency and Picture Naming subtests and the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Similarities and Digit Span subtests. All scores will be standard scores based on age norms.

Post-acute COVID symptoms (PACS)

Frequency and severity of 38 PACS symptoms will be assessed daily via an online survey. Each symptom will be rated on a scale of 0 (not present) to 5 (severe).

Physical Function

Physical function will be measured weekly via self-report with the Physical Function Short Form-36. Scores can range from 0 to 100 and higher scores indicate better function.

Secondary Outcome Measures

Depression

Depression will be measured weekly with the Center for Epidemiological Studies Depression Scale - Revised (CESD-R). Scores range from 0 to 60 and higher scores indicate greater depression severity.

Generalized anxiety

Generalized anxiety will be measured weekly using the Generalized Anxiety Disorder - 2 (GAD-2). Scores range from 0 to 6 and higher scores indicate greater anxiety severity.

State anxiety

Anxiety will be measured weekly using the State Trait Anxiety Inventory (STAI) - State scale. Scale scores range from 20 to 80, with higher scores indicating greater state anxiety.

Trait anxiety

Trait anxiety will be measured weekly using the State Trait Anxiety Inventory (STAI) - Trait scale. Scores can range from 20 to 80, with higher scores indicating greater trait anxiety.

Improvement in quality of life

Quality of life will be measured weekly with the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). Raw scores range from 14 to 70 and will be converted to a percentage score based on the following formula: (raw total score -minimum score)/(maximum possible raw score -minimum score). Higher scores indicate greater life satisfaction.

Perception of cognitive function

Perception of cognitive function will be assessed with the Neuro-QOL Cognitive function subscale which measures self-reported cognitive functioning over the past week, including perceptions of memory, executive functions, processing speed, and learning. Raw scores can range from 8 to 40, and will be converted to T-scores based on the administration manual norms. Higher scores indicated better perceived cognitive function. We have modified the baseline administration to also assess whether perceived cognitive function has changed since onset of acute COVID-19.

Full Information

NCT ID

NCT04898205

First Posted

May 17, 2021

Last Updated

May 21, 2021

Sponsor

Noah Greenspan

Collaborators

University of Dayton

1. Study Identification

Unique Protocol Identification Number

NCT04898205

Brief Title

Cardiopulmonary Rehabilitation in COVID-19 Longhaulers

Official Title

Cardiopulmonary Rehabilitation in COVID-19 Longhaulers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 21, 2021 (Actual)

Primary Completion Date

January 20, 2022 (Anticipated)

Study Completion Date

January 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Noah Greenspan

Collaborators

University of Dayton

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will test the efficacy of treadmill exercise combined with supplemental oxygen during exercise and recovery for the treatment of persistent post-acute COVID-19 symptoms. Participants will be pseudo-randomized (stratified by age) to one of four conditions for 8 treatment sessions: 1) treadmill exercise plus supplemental oxygen, 2) treadmill exercise plus air, 3) supplemental oxygen only, 4) air only. All participants will then cross-over and receive 16 additional sessions of treadmill exercise plus supplemental oxygen.

Detailed Description

This study will test the efficacy of a COVID-19 specific cardiopulmonary rehabilitation protocol for treatment of persistent post-acute COVID symptoms and to study the impact of cardiopulmonary improvement on cognition, mental health, and function. Participants (N=36) with persistent post-acute COVID symptoms will undergo pre-treatment neurocognitive, orthostatic tolerance, and exercise tolerance tests before being pseudo-randomized (stratified by age and sex) to one of four conditions (all of which occur twice a week): 1) 8 sessions of treadmill exercise plus supplemental oxygen, 2) 8 sessions of treadmill exercise plus air, 3) 8 sessions of supplemental oxygen only, and 4) 8 sessions of air only. The pre-treatment testing will be repeated, after which all participants will receive 16 additional sessions of treadmill exercise plus supplemental oxygen, followed by post-treatment testing. All participants will complete baseline measures of physical and mental health, physical function, emotional wellbeing, and coping. A brief symptom measure will be collected daily and physical function, mental health, and emotional wellbeing will be assessed weekly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Viral Syndrome

Keywords

Post-COVID Syndrome, Post-acute COVID, Long COVID

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This study entails 24 treatment sessions. The first 8 sessions involve four experimental conditions: 1) exercise + oxygen (treatment), exercise + air (active control), oxygen only (active control), air only (placebo). Pre-treatment testing will then be repeated, after which all participants will crossover to 16 sessions of exercise + oxygen.

Masking

Participant

Masking Description

All participants will be blind to whether they receive supplemental oxygen or air during the first 8 sessions.

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treadmill Exercise with Supplemental Oxygen

Arm Type

Experimental

Arm Description

Arm Title

Treadmill Exercise with Air

Arm Type

Sham Comparator

Arm Description

Arm Title

Supplemental Oxygen Only

Arm Type

Sham Comparator

Arm Description

Arm Title

No Intervention

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Treadmill Exercise

Other Intervention Name(s)

Supplemental oxygen (6 liters per minute)

Intervention Description

The cardiopulmonary rehabilitation protocol utilizes progressive treadmill exercise with alternating increases in intensity and incline with no more than 0.5 Met increase per session.

Intervention Type

Other

Intervention Name(s)

Concentrated Oxygen

Intervention Description

Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.

Intervention Type

Other

Intervention Name(s)

Concentrated Air

Intervention Description

Room air will be delivered through an concentrator provided via nasal cannula.

Primary Outcome Measure Information:

Title

Heart rate and rhythm response to exercise and positional changes

Description

Heart rate and rhythm will be measured using 3-lead ECG telemetry

Time Frame

Up to 24-weeks

Title

Blood pressure response to exercise and positional changes

Description

Blood pressure will be measured via manual cuff

Time Frame

Up to 24-weeks

Title

Activity metabolic equivalent of task (MET) tolerated

Description

Time Frame

Up to 24-weeks

Title

Breathlessness

Description

Breathlessness will be assessed during peak exercise via self-report using the Borg Dyspnea scale. Scores can range from 0 to 20 and higher scores indicate more breathlessness

Time Frame

Up to 24-weeks

Title

Rate of perceived exertion (RPE)

Description

RPE will be assessed during peak exercise via self-report using the Borg RPE scale. Scores can range from 0 to 20 and higher scores indicate more RPE.

Time Frame

Up to 24-weeks

Title

Cognition (attention, short, delayed, and working memory, verbal fluency, and abstraction).

Description

Time Frame

Up to 24-weeks

Title

Post-acute COVID symptoms (PACS)

Description

Frequency and severity of 38 PACS symptoms will be assessed daily via an online survey. Each symptom will be rated on a scale of 0 (not present) to 5 (severe).

Time Frame

Up to 24-weeks

Title

Physical Function

Description

Physical function will be measured weekly via self-report with the Physical Function Short Form-36. Scores can range from 0 to 100 and higher scores indicate better function.

Time Frame

Up to 24-weeks

Secondary Outcome Measure Information:

Title

Depression

Description

Depression will be measured weekly with the Center for Epidemiological Studies Depression Scale - Revised (CESD-R). Scores range from 0 to 60 and higher scores indicate greater depression severity.

Time Frame

Up to 24-weeks

Title

Generalized anxiety

Description

Generalized anxiety will be measured weekly using the Generalized Anxiety Disorder - 2 (GAD-2). Scores range from 0 to 6 and higher scores indicate greater anxiety severity.

Time Frame

Up to 24-weeks

Title

State anxiety

Description

Anxiety will be measured weekly using the State Trait Anxiety Inventory (STAI) - State scale. Scale scores range from 20 to 80, with higher scores indicating greater state anxiety.

Time Frame

Up to 24-weeks

Title

Trait anxiety

Description

Trait anxiety will be measured weekly using the State Trait Anxiety Inventory (STAI) - Trait scale. Scores can range from 20 to 80, with higher scores indicating greater trait anxiety.

Time Frame

Up to 24-weeks

Title

Improvement in quality of life

Description

Time Frame

Up to 24-weeks

Title

Perception of cognitive function

Description

Time Frame

Up to 24-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Between the ages of 18-60 Contracted COVID-19 between February - July 2020 Has been clinician-diagnosed with COVID-19 based on PCR/antigen testing, antibody testing, or clinical symptoms Is currently experiencing one or more of the following symptoms, which began only after contracting COVID-19 : dyspnea, cough, chest pain, tachycardia or other arrhythmias, hypertension, hypotension, blood pressure lability, oxygen desaturation, exercise/activity intolerance, fatigue, or dizziness. Has been cleared by a physician for exercise and supplemental oxygen. Has the capacity to provide written, informed consent Able to complete questionnaires in English Exclusion Criteria: History of any of the following per the American College of Sports Medicine exercise testing guidelines (American College of Sports Medicine et al., 2018) to be determined during a screening consultation: Acute myocardial infarction within the past two days Ongoing unstable angina Uncontrolled cardiac arrhythmias Active endocarditis Symptomatic severe aortic stenosis Decompensated heart failure Active pulmonary embolism, pulmonary infarction, or deep venous thrombosis Active myocarditis or pericarditis Acute aortic dissection Physical disability that precludes safe and adequate testing Participants who demonstrate orthostatic intolerance or oxygen desaturation (<90%) during the exercise tolerance test will no longer be eligible for the study because it is not safe for them to exercise on a treadmill.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Noah Greenspan, DPT

Phone

(212) 249-0904

consult@covidpt.org

First Name & Middle Initial & Last Name or Official Title & Degree

Julie Walsh-Messinger, Ph.D.

Phone

(937) 229-1380

udcovidstudy@udayton.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noah Greenspan, DPT

Organizational Affiliation

Pulmonary Wellness Foundation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Julie Walsh-Messinger, Ph.D.

Organizational Affiliation

University of Dayton

Official's Role

Principal Investigator

Facility Information:

Facility Name

Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy

City

New York

State/Province

New York

ZIP/Postal Code

10017

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Noah Greenspan, DPT

Phone

212-921-0214

consult@covidpt.org

First Name & Middle Initial & Last Name & Degree

Julie Walsh-Messinger, PhD

Phone

(937) 229-1380

udcovidstudy@udayton.edu

First Name & Middle Initial & Last Name & Degree

Noah Greenspan, DPT, CCS

First Name & Middle Initial & Last Name & Degree

Julie Walsh-Messinger, PhD

First Name & Middle Initial & Last Name & Degree

Marion Mackles, BS, PT

First Name & Middle Initial & Last Name & Degree

Marcella Debidda, PhD

First Name & Middle Initial & Last Name & Degree

Robert Kaner, MD

First Name & Middle Initial & Last Name & Degree

Louis DePalo, MD

First Name & Middle Initial & Last Name & Degree

Gregory Hullstrung, PT, FAFS

First Name & Middle Initial & Last Name & Degree

Wai Chin, MS

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Upon conclusion of the study, we will share de-identified data upon request.

Links:

URL

https://pulmonarywellness.org/research/

Description

Pulmonary Wellness Foundation

URL

https://www.hdphysicaltherapy.com/post-covid/

Description

Pulmonary Wellness Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy

URL

https://juliewalshmessinger.weebly.com/research-studies.html

Description

Psychopathology, Personality, and Affective Science (PPAS) Laboratory at the University of Dayton

Learn more about this trial

Cardiopulmonary Rehabilitation in COVID-19 Longhaulers

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