Chronic Fatigue SyndromeNCT03567811
Exertional Exhaustion in Chronic Fatigue Syndrome
A study testing Submaximal bicycle exercise stress test on Days 1 and 2 in people with Chronic Fatigue Syndrome, run by Georgetown University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Submaximal bicycle exercise stress test on Days 1 and 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2013to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CFS and healthy subjects
Who cannot join
- 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.
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- 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.
About this study
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.
Read the 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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Submaximal bicycle exercise stress test on Days 1 and 2
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submaximal bicycle exercise stress test on Days 1 and 2Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Chronic Fatigue Syndrome | Other | 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 Receives: Procedure: Submaximal bicycle exercise stress test on Days 1 and 2 |
| Sedentary Control | Other | 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 Receives: Procedure: Submaximal bicycle exercise stress test on Days 1 and 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood oxygenation level dependent (BOLD) patterns of brain blood flow during cognitive testing
MRI with cognitive tasks were performed before Day 1 exercise and compared to after the Day 2 exercise.
Measured: Day 1 (pre-exercise) and Day 2 (after 2nd exercise)
Secondary outcomes (2)
Postural change in heart rate and heart rate variability 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.
Measured: Before exercise. 1, 3, 8, 24 and 36 hours after exercise
Pressure-induced pain (systemic hyperalgesia) by dolorimetry
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.
Measured: 10 am each day for 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Aug 2013
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All subjects were participated in an identical protocol. Outcomes were compared between control and Chronic Fatigue Syndrome subjects.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Baraniuk, MD, Georgetown University
- Investigators
- Kristen Katopol, Study chair, IRB Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567811
- Sponsor's protocol ID
- 2013-0943
- Status last verified
- Jun 2019
- First submitted
- 20 Apr 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: RedCap
Publications
Garner R, Baraniuk JN. Orthostatic intolerance in chronic fatigue syndrome. J Transl Med. 2019 Jun 3;17(1):185. doi: 10.1186/s12967-019-1935-y.
PubMed 31159884Timbol CR, Baraniuk JN. Chronic fatigue syndrome in the emergency department. Open Access Emerg Med. 2019 Jan 11;11:15-28. doi: 10.2147/OAEM.S176843. eCollection 2019.
PubMed 30666170Rayhan RU, Ravindran MK, Baraniuk JN. Migraine in gulf war illness and chronic fatigue syndrome: prevalence, potential mechanisms, and evaluation. Front Physiol. 2013 Jul 24;4:181. doi: 10.3389/fphys.2013.00181. eCollection 2013.
PubMed 23898301Baraniuk JN. Chronic Fatigue Syndrome prevalence is grossly overestimated using Oxford criteria compared to Centers for Disease Control (Fukuda) criteria in a U.S. population study. Fatigue. 2017;5(4):215-230. doi: 10.1080/21641846.2017.1353578. Epub 2017 Jul 21.
PubMed 30854252Baraniuk JN, Shivapurkar N. Exercise - induced changes in cerebrospinal fluid miRNAs in Gulf War Illness, Chronic Fatigue Syndrome and sedentary control subjects. Sci Rep. 2017 Nov 10;7(1):15338. doi: 10.1038/s41598-017-15383-9.
PubMed 29127316Baraniuk JN, Shivapurkar N. Author Correction: Exercise - induced changes in cerebrospinal fluid miRNAs in Gulf War Illness, Chronic Fatigue Syndrome and sedentary control subjects. Sci Rep. 2018 Apr 19;8(1):6455. doi: 10.1038/s41598-018-23238-0.
PubMed 29674668
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exertional Exhaustion in Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT03567811
- Acronym / sponsor ID
- 2013-0943
- Conditions
- Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All subjects were participated in an identical protocol. Outcomes were compared between control and Chronic Fatigue Syndrome subjects.
| Arm | Type | Receives |
|---|---|---|
| Chronic Fatigue Syndrome | Other | Procedure: Submaximal bicycle exercise stress test on Days 1 and 2Inclusion 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 |
| Sedentary Control | Other | Procedure: Submaximal bicycle exercise stress test on Days 1 and 2Subjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CFS and healthy subjects
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submaximal bicycle exercise stress test on Days 1 and 2Identical 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. | Procedure or surgery | Chronic Fatigue Syndrome, Sedentary Control |
Primary outcome
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.
2 secondary outcomes
Postural change in heart rate and heart rate variability after exercise
Time frame: Before exercise. 1, 3, 8, 24 and 36 hours after exercise
Pressure-induced pain (systemic hyperalgesia) by dolorimetry
Time frame: 10 am each day for 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Results publication: PubMed 31159884Garner R, Baraniuk JN. Orthostatic intolerance in chronic fatigue syndrome. J Transl Med. 2019 Jun 3;17(1):185. doi: 10.1186/s12967-019-1935-y.
- Results publication: PubMed 30666170Timbol CR, Baraniuk JN. Chronic fatigue syndrome in the emergency department. Open Access Emerg Med. 2019 Jan 11;11:15-28. doi: 10.2147/OAEM.S176843. eCollection 2019.
- Results publication: PubMed 23898301Rayhan RU, Ravindran MK, Baraniuk JN. Migraine in gulf war illness and chronic fatigue syndrome: prevalence, potential mechanisms, and evaluation. Front Physiol. 2013 Jul 24;4:181. doi: 10.3389/fphys.2013.00181. eCollection 2013.
- Results publication: PubMed 30854252Baraniuk JN. Chronic Fatigue Syndrome prevalence is grossly overestimated using Oxford criteria compared to Centers for Disease Control (Fukuda) criteria in a U.S. population study. Fatigue. 2017;5(4):215-230. doi: 10.1080/21641846.2017.1353578. Epub 2017 Jul 21.
- Results publication: PubMed 29127316Baraniuk JN, Shivapurkar N. Exercise - induced changes in cerebrospinal fluid miRNAs in Gulf War Illness, Chronic Fatigue Syndrome and sedentary control subjects. Sci Rep. 2017 Nov 10;7(1):15338. doi: 10.1038/s41598-017-15383-9.
- Results publication: PubMed 29674668Baraniuk JN, Shivapurkar N. Author Correction: Exercise - induced changes in cerebrospinal fluid miRNAs in Gulf War Illness, Chronic Fatigue Syndrome and sedentary control subjects. Sci Rep. 2018 Apr 19;8(1):6455. doi: 10.1038/s41598-018-23238-0.
- Individual participant dataSharing planned: Yes. RedCap
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Katopol study chair
IRB Director
Questions about this trial
What is this clinical trial studying?
A study testing Submaximal bicycle exercise stress test on Days 1 and 2 in people with Chronic Fatigue Syndrome, run by Georgetown University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03567811, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.