- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331419
Exercise-related Post-exertional Malaise (CFS/ME)
Sex Differences in Exercise-related Post-exertional Malaise in ME/CFS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This supplement to the parent study, Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS): Activity patterns and autonomic function, is intended to enhance the larger home-based study with a face-to-face laboratory arm. Specifically, the investigators propose a pilot study to assess biobehavioral sex differences in ME/CFS during recovery after a brief high exertion exercise task, i.e., a six-minute walk test repeated on two consecutive days. The investigators expect adverse symptomatic, functional, and autonomic effects following this repeat exercise test. This "post-exertional malaise (PEM)" and its impact on global outcomes is a unique feature of ME/CFS that is being studied in the parent observational study conducted by participants entirely in their homes. In the proposed supplement, PEM and its impacts will be captured in real time under controlled conditions in the research team's laboratory. Of particular interest, autonomic effects of PEM on heart function and blood pressure using non-invasive research grade monitors. The specific aims are as follows:
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: FRED FRIEDBERG, PhD
- Phone Number: 631-638-1931
- Email: fred.friedberg@stonybrookmedicine.edu
Study Contact Backup
- Name: Patricia Bruckenthal, PhD
- Phone Number: 631-444-1172
- Email: patricia.bruckenthal@stonybrook.edu
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794-8101
- Stony Brook University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients aged 18-65 of both sexes who are considered physically capable of doing and blood pressure monitors (10 min/day) and an actigraph (16 days; waking hours only).
- 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:
- Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS.
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
30 sec of knee squats followed by a six minute walk test repeated on consecutive days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability
Time Frame: 15 days
|
The time and frequency variation in heart rate recorded on a portable heart monitor
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six minute walk distance (m)
Time Frame: 24 hours
|
Distance walked on the six minute walk test
|
24 hours
|
Blood pressure
Time Frame: 24 hours
|
Blood pressure taken before and after six minute walk tests
|
24 hours
|
Physical activity
Time Frame: 15 days
|
The daily physical activity levels measured with an accelerometer
|
15 days
|
Online web diary
Time Frame: 15 days
|
Symptom intensities recorded on online web diary
|
15 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fred Friedberg, PhD, Stony Brook University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3R01NR015850-02S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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