Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2017-11-30
2018-10-31
Brief Summary
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Detailed Description
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Specific Aim 1: After two high-effort six minute walk tests conducted on consecutive days, female subjects with ME/CFS as compared to male ME/CFS subjects will show slower recovery with respect to cardiovascular autonomic functioning, physical functioning, and symptom resolution. Specific Aim 2: Female subjects with ME/CFS as compared to males with ME/CFS will show greater adverse impact on autonomic and physical functioning and symptom severity after the day 2 exercise test.
To more accurately characterize exercise recovery abnormalities differentiated by sex, the investigators propose to longitudinally monitor symptoms, activity levels, and autonomic status during the week before (baseline) as compared to the week after (follow-up) the two exercise tests. This pilot study will also provide potential cross-validation of the parent project which hypothesizes specific relationships between autonomic function symptom severity and activity limitations. A parallel analysis of sex differences will also be carried out on the data collected in the parent project.
The pilot study will remain within the scope of the original aims of the parent study to identify biobehavioral factors related to PEM, symptom-worsening activity patterns, and non-improvement in ME/CFS. This supplement will expand the parent project's home-based data collection to a controlled setting with direct observation and verification of exercise tests carried out by participants in the principal investigator's laboratory.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Males with Chronic Fatigue Syndrome
Two brief high effort exercise tests on consecutive days in our laboratory in order to provoke abnormalities in ME/CFS patients with respect to autonomic function, symptom exacerbation, and activity limitations.
Exercise test
30 sec of knee squats followed by a six minute walk test repeated on consecutive days.
Females with Chronic Fatigue Syndrome
Two brief high effort exercise tests on consecutive days in our laboratory in order to provoke abnormalities in ME/CFS patients with respect to autonomic function, symptom exacerbation, and activity limitations.
Exercise test
30 sec of knee squats followed by a six minute walk test repeated on consecutive days.
Interventions
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Exercise test
30 sec of knee squats followed by a six minute walk test repeated on consecutive days.
Eligibility Criteria
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Inclusion Criteria
* subjects must meet validated phone-screen eligibility for CFS which will also require the symptom of post-exertional malaise. Also 3 out of 7 secondary symptoms of ME/CFS are required i.e., headaches, tender lymph nodes, sore throat, myalgias, arthralgias, sleep disturbance, and/or problems with memory or concentration.
Exclusion Criteria
* psychiatric disorders include any psychosis, or alcohol/ substance abuse within two years prior to illness onset and any time afterward, and current or past depression with melancholic or psychotic features within 5 years prior to onset of ME/CFS or anytime afterward.
* patients on heart medication or patients not dose-stabilized for at least 3 months on antidepressant drugs
* patients at significant risk of suicide or in need of urgent psychiatric treatment.
18 Years
65 Years
ALL
No
Sponsors
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Stony Brook University
OTHER
Responsible Party
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Principal Investigators
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Fred Friedberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University
Locations
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Stony Brook University
Stony Brook, New York, United States
Countries
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Central Contacts
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References
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Friedberg F, Adamowicz JL, Bruckenthal P, Milazzo M, Ramjan S, Zhang X, Yang J. Sex differences in post-exercise fatigue and function in myalgic encephalomyelitis/chronic fatigue syndrome. Sci Rep. 2023 Apr 3;13(1):5442. doi: 10.1038/s41598-023-32581-w.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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