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

NCT ID: NCT04026425

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2023-03-31

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.

Detailed Description

The phenomenon of post-exertional malaise (PEM), in which an ME/CFS patient's symptoms are elevated following even low-level exertion, is a hallmark feature of the disease. The cause of PEM, like the cause of ME/CFS, is not understood. This study aims to utilize a two-day CPET to invoke PEM. This provides a unique opportunity to collect data on how key outcome measures or disease parameters are altered during elevated symptoms relative to baseline within each patient by gathering information before and after symptom provocation.

A total of 90 participants and 90 controls will undergo CPET testing. Participation will be split amongst three different sites (Ithaca, NY, New York, NY, and Los Angeles, CA). Subjects will be located in urban and rural areas to establish relatively diverse study populations.

This study is a component of the Cornell ME/CFS Collaborative Research Center (CRC). Blood samples taken before and after CPET will be utilized in associated projects with the Cornell ME/CFS CRC. CPET data along with the analysis of blood samples has great potential to reveal why exercise negatively affects ME/CFS patients and thus perhaps why patients are also impaired even before increasing their activity level.

Conditions

Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ME/CFS

Adults with ME/CFS

Group Type: EXPERIMENTAL

Two-day cardiopulmonary exercise test

Intervention Type: 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

Healthy, low-active adults

Group Type: ACTIVE_COMPARATOR

Two-day cardiopulmonary exercise test

Intervention Type: 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.

Interventions

Two-day cardiopulmonary exercise test

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Healthy
• Low-active
• Adults 18 to 70 years of age

Exclusion Criteria

• 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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cornell University

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Workwell Foundation

UNKNOWN

Sponsor Role: collaborator

Ithaca College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betsy Keller, Ph.D.

Role: STUDY_DIRECTOR

Ithaca College

Geoff Moore, M.D.

Role: STUDY_DIRECTOR

Ithaca College

Locations

ID Med

Torrance, California, United States

Ithaca College

Ithaca, New York, United States

Weill Cornell Medicine

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38965566 (View on PubMed)

Related Links

https://neuroimmune.cornell.edu/research/

Related information

Other Identifiers

5U54NS105541

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U54NS105541

Identifier Type: NIH

Identifier Source: org_study_id

View Link