Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS

NCT04026425 | Completed

• 2 other identifiers: U54NS1055415U54NS105541
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to collect and identify key outcome measures or disease parameters in ME/CFS that are altered during elevated symptoms relative to baseline by gathering information before and after symptom provocation using a two-day cardiopulmonary exercise test.

Conditions

Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Keywords

cardiopulmonary exercise test (CPET); post-exertional malaise (PEM)

Outcome Measures

Primary Outcomes (9)

• Volume of oxygen consumed at peak effort

  Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.

  During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

• Volume of oxygen consumed at ventilatory/anaerobic threshold (VAT)

  VAT is a non-invasive surrogate measure for anaerobic threshold, which is indicated during incremental exercise by a non-linear increase in rate of carbon dioxide production relative to rate of oxygen consumption.

  During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

• Rate of work performed at peak effort

  Rate of work performed at peak effort during CPET 1 and during CPET 2. Rate of work is measured in Watts.

  During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

• Rate of work performed at VAT

  Rate of work performed at VAT during CPET 1 and during CPET 2. Rate of work is measured in Watts.

  During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

• Heart rate at peak effort

  Heart rate at peak effort during CPET 1 and during CPET 2.

  During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

• Heart rate at VAT

  Heart rate at VAT during CPET 1 and during CPET 2.

  During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

• Systolic blood pressure at seated rest

  Systolic blood pressure at seated rest 1-minute before the start of CPET 1 and 1-minute before the start of CPET 2.

  During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

• Systolic blood pressure at peak effort

  Systolic blood pressure at peak effort during CPET 1 and during CPET 2.

  During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

• Respiratory Exchange Ratio (RER) at peak effort

  RER at peak effort during CPET 1 and during CPET 2. RER is calculated as the rate of carbon dioxide production divided by the rate of oxygen consumption, and during exercise is an indicator of participant effort.

  During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

Study Arms (2)

ME/CFS

EXPERIMENTAL

Adults with ME/CFS

Other: Two-day cardiopulmonary exercise test

Healthy controls

ACTIVE COMPARATOR

Healthy, low-active adults

Other: Two-day cardiopulmonary exercise test

Interventions

Two-day cardiopulmonary exercise test OTHER

A series of two cardiopulmonary exercise tests (CPETs) performed over two days. Participants will perform a CPET and then will return approximately 24 hours later to perform the second CPET. The CPET begins with 3 minutes of seated rest followed by cycling during incremental workloads which increases 15 watts throughout each minute of exercise. The participant will cycle until volitional exhaustion and/or the participant and/or test administrator determines to stop the test. Actual exercise time usually varies between 8-10 minutes.

Healthy controls; ME/CFS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with ME/CFS
• Adults 18 to 70 years of age

You may not qualify if:

• Recent history of panic attacks within the past 6 months
• Diagnosis of schizophrenia, major depressive disorder, bipolar disorder, or an anxiety disorder such as OCD or PTSD
• Hospitalized for a psychological condition within the last 6 months
• Unwilling to stop taking nutritional supplements, including probiotics, two weeks before the exercise tests.
• Unwilling to stop pain medication and stimulant medication two days before the exercise tests.
• Smoker, or stopped smoking less than 1 year ago
• Pregnant or breastfeeding
• Diabetic
• Have an orthopedic limitation that prohibits cycle exercise
• Excessive alcohol consumption
• Healthy Volunteers:
• Healthy
• Low-active
• Adults 18 to 70 years of age
• Recent history of panic attacks within the past 6 months

Sponsors & Collaborators

• Ithaca College: lead
• Cornell University: collaborator
• Weill Medical College of Cornell University: collaborator
• Workwell Foundation: collaborator

Study Sites (3)

ID Med

Torrance, California, 90505, United States

Location

Ithaca College

Ithaca, New York, 14850, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Related Publications (1)

• Keller B, Receno CN, Franconi CJ, Harenberg S, Stevens J, Mao X, Stevens SR, Moore G, Levine S, Chia J, Shungu D, Hanson MR. Cardiopulmonary and metabolic responses during a 2-day CPET in myalgic encephalomyelitis/chronic fatigue syndrome: translating reduced oxygen consumption to impairment status to treatment considerations. J Transl Med. 2024 Jul 5;22(1):627. doi: 10.1186/s12967-024-05410-5.

  PMID: 38965566 DERIVED

Related Links

• Related information

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Betsy Keller, Ph.D.

  Ithaca College

  STUDY DIRECTOR

• Geoff Moore, M.D.

  Ithaca College

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 19, 2019
• Study Start: August 1, 2018
• Primary Completion: March 15, 2022
• Study Completion: March 31, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

US (3)