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

NCT04026425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2023-07-07

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Cornell University

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Workwell Foundation

    collaborator UNKNOWN

  • Ithaca College

    lead OTHER

Principal Investigators

  • Betsy Keller, Ph.D. · Ithaca College

  • Geoff Moore, M.D. · Ithaca College

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2022-03-15
Completion
2023-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04026425 on ClinicalTrials.gov