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Exertional Exhaustion in Chronic Fatigue Syndrome

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ClinicalTrials.gov Identifier: NCT03567811
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
James Baraniuk, MD, Georgetown University

Tracking Information
First Submitted Date  ICMJE April 20, 2018
First Posted Date  ICMJE June 26, 2018
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE August 1, 2013
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
Change in blood oxygenation level dependent (BOLD) patterns of brain blood flow during cognitive testing [ Time Frame: Day 1 (pre-exercise) and Day 2 (after 2nd exercise) ]
MRI with cognitive tasks were performed before Day 1 exercise and compared to after the Day 2 exercise.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • Postural change in heart rate and heart rate variability after exercise [ Time Frame: Before exercise. 1, 3, 8, 24 and 36 hours after exercise ]
    Heart rates were recorded while subjects resting supine for 5 minutes, and during 5 minutes of standing. The change in heart rate (deltaHR) was calculated.
  • Pressure-induced pain (systemic hyperalgesia) by dolorimetry [ Time Frame: 10 am each day for 4 days ]
    A strain gauge (algometer, dolorimeter) was pressed over 18 traditional fibromyalgia tender point locations at a slow rate < kg/sec with the subject instructed to tell the operator to stop pushing as soon as they felt pain.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exertional Exhaustion in Chronic Fatigue Syndrome
Official Title  ICMJE Exertional Exhaustion in Chronic Fatigue Syndrome
Brief Summary Post-exertional malaise was modeled by having Chronic Fatigue Syndrome (CFS) and sedentary control subjects perform submaximal exercise on 2 consecutive days with objective changes in brain function measured by magnetic resonance imaging (MRI) during cognitive tests before and after the 2 exercise sessions.
Detailed Description

Chronic Fatigue Syndrome (CFS) and sedentary control subjects answered on-line advertisements and word-of-mouth communications. Candidates gave verbal informed consent to discuss their medical history during a telephone interview. If the met inclusion and exclusion criteria, they were assigned an log-in code and password to complete an extensive on-line questionnaire, and were scheduled for the 3 day in-patient study.

On the Screening Day subjects completed written informed consent, history and physical, screening blood work, mental status exam, heart rate variability for orthostasis, and dolorimetry for systemic hyperalgesia.

On Exercise Day 1, subjects had magnetic resonance imaging (MRI) for structure (MPRAGE), white matter integrity (diffusion tensor imaging, DTI), and blood oxygenation level dependent (BOLD) analysis during working memory tasks. The tasks were the simple stimulus-response 0-back "see a letter, push a button" task, and the difficult continuous 2-back task "see a string of letters, remember the letters in order, press the button for the letter seen 2 previously ("2-back)".

The submaximal exercise test was performed in identical fashion on day 1 and day 2. Subjects rested on a bicycle ergometer for 5 minutes for baseline cardiopulmonary (VO2) measurements. They began pedalling with resistance increased in step wise fashion until their heart rate reached 70% of predicted maximum heart rate (pHR = 220 - age). They pedaled 25 minutes at 70% or until they felt they had their personal maximum effort (e.g. Borg Exertional Scale 19/20). If they reached 25 minutes, then resistance was increased until they reached 85% of pHR. Continuous EKG, symptoms and VO2 were followed from rest until 5 minutes after peak exercise.

Heart rate variability and symptoms were assessed during recumbent and standing posture to assess orthostatic intolerance.

On Exercise Day 2, the same methods were used, but the order was reversed with the submaximal exercise test first, followed by the identical MRI protocol.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
All subjects were participated in an identical protocol. Outcomes were compared between control and Chronic Fatigue Syndrome subjects.
Masking: None (Open Label)
Masking Description:
All control and Chronic Fatigue Syndrome subjects were treated in identical fashion.
Primary Purpose: Basic Science
Condition  ICMJE Chronic Fatigue Syndrome
Intervention  ICMJE Procedure: Submaximal bicycle exercise stress test on Days 1 and 2
Identical submaximal stress tests were performed on both days to see if Day 1 exercise reduced performance on Day 2, or caused changes between BOLD scans during cognitive testing between Day 1 and Day 2.
Study Arms  ICMJE
  • Chronic Fatigue Syndrome
    Inclusion and exclusion criteria based on 1994 Center for Disease Control ("Fukuda") criteria of persistent, disabling, moderate to severe fatigue that was relieved by rest, plus at least 4 of the 8 following ancillary features: cognitive dysfunction affecting short term memory or concentration, sore throat, sore lymph nodes, sore muscles, sore joints, headache, sleep disturbance, and exertional exhaustion (post-exertional malaise). Intervention: Procedure/Surgery: Submaximal bicycle exercise stress test on Days 1 and 2
    Intervention: Procedure: Submaximal bicycle exercise stress test on Days 1 and 2
  • Sedentary Control
    Subjects who lived a sedentary lifestyle, did not meet Chronic Fatigue Syndrome criteria, and did not have any exclusionary chronic medical, psychiatric or other conditions were our Sedentary Control subjects. By design, this control group included controlled Type II diabetes and thyroid disease, chronic idiopathic fatigue, hypertension (other heart disease excluded) and other stable medical conditions. This variety of subjects were included to prevent ceiling (CFS) vs. floor (control) effects if the control group had totally pristine subjects with zero health issues. Intervention: Procedure/Surgery: Submaximal bicycle exercise stress test on Days 1 and 2
    Intervention: Procedure: Submaximal bicycle exercise stress test on Days 1 and 2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2018)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

CFS and healthy subjects

Exclusion Criteria:

  • HIV / AIDS subjects
  • Pregnant women
  • Lactation
  • Cognitive impairment, mental retardation, severe head injury, stroke, proven multiple sclerosis, "melancholic" suicidal major depression, schizophrenia, Alzheimer's disease, "mild cognitive impairment" (MCI), other dementia, or other serious neurological diseases
  • Brain injury. stroke, severe head injury (concussion, severe motor vehicle accidents), bleeding into brain, have been unconscious for more than 1 day (in a coma), seizures, brain inflammation such as multiple sclerosis or lupus.
  • Metal implants such as prostheses, wires, plates, or screws that may heat up in the magnetic resonance imaging scanner and cause harm.
  • Claustrophobia.
  • Abnormal laboratory and questionnaire results.
  • Heart, lung, kidney, arthritis, autoimmune, cancer, and other chronic illnesses, leg amputations heart attacks (myocardial infarction), coronary artery disease, abnormal heart rhythms, congestive heart failure, heart valve disease, uncontrolled high blood pressure or strokes, lung disease from smoking or other causes, painful, swollen or deformed joints related to arthritis or autoimmune diseases, weakness from nerve damage, kidney disease on dialysis, liver disease (alcoholic cirrhosis, hepatitis B, hepatitis C), inflammatory bowel disease (Crohn's disease, ulcerative colitis), or cancer Subjects may participate if they have well-controlled diabetes or thyroid disease.

Any other chronic disease with chronic pain, fatigue and thinking problems (cognitive impairment) that would limit the ability to complete the questionnaires and other tests.

  • Amputation that would prevent bicycle exercise.
  • Medications. Drugs that interfere with heart, lung, brain and nerve function
  • Drinking and Smoking. You will have to stop caffeine (coffee, tea, soft drinks), alcohol, cannabis and nicotine products (smoking) for 3 days before the study, and the full period of the testing.
  • Difficulties Drawing Blood.
  • Children under the age of 18 years
  • Incarcerated people (in jail)
  • Alcohol or substance abuse in the past 6 months.
  • English: Subjects must be able to speak and understand English to be able to understand the tests and other instructions during the study.
  • Disruptive: Subjects who are disruptive or may reveal medical information about other subjects will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03567811
Other Study ID Numbers  ICMJE 2013-0943
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: RedCap
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 2019
Access Criteria: open
Responsible Party James Baraniuk, MD, Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kristen Katopol IRB Director
PRS Account Georgetown University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP