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Exercise-related Post-exertional Malaise (CFS/ME)

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ClinicalTrials.gov Identifier: NCT03331419
Recruitment Status : Unknown
Verified October 2017 by Stony Brook University.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Stony Brook University

Brief Summary:
This pilot study is intended to identify sex differences in myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) during recovery from brief but high effort exercise tests. It is expected that women with ME/CFS as compared to males with ME/CFS will show slower recovery from exercise with respect to heart rate and blood pressure, physical functioning, and symptom severity. Also females with ME/CFS as compared to males with ME/CFS will show greater negative impacts on heart rate, blood pressure, physical functioning and symptom severity after the two exercise tests. The findings will have implications for sex differences in the pathophysiology of post-exertional malaise and activity/exercise self-management recommendations, given the expected detrimental effects of the brief intense exercise tests on patients with ME/CFS.

Condition or disease Intervention/treatment
Chronic Fatigue Syndrome Behavioral: Exercise test

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.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sex Differences in Exercise-related Post-exertional Malaise in ME/CFS
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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.
Behavioral: 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.
Behavioral: Exercise test
30 sec of knee squats followed by a six minute walk test repeated on consecutive days.




Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 15 days ]
    The time and frequency variation in heart rate recorded on a portable heart monitor


Secondary Outcome Measures :
  1. Six minute walk distance (m) [ Time Frame: 24 hours ]
    Distance walked on the six minute walk test

  2. Blood pressure [ Time Frame: 24 hours ]
    Blood pressure taken before and after six minute walk tests

  3. Physical activity [ Time Frame: 15 days ]
    The daily physical activity levels measured with an accelerometer

  4. Online web diary [ Time Frame: 15 days ]
    Symptom intensities recorded on online web diary



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study sample will be drawn from the population of patients with CFS who (a) respond to local recruitment ads placed online in University announcements and local newspapers; and (b) CFS subjects who have completed the parent study. Ads will emphasize that the study will help to advance our understanding of the biology of CFS (e.g., autonomic functioning).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331419


Contacts
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Contact: Patricia Bruckenthal, PhD 631-444-1172 patricia.bruckenthal@stonybrook.edu
Contact: Fred Friedberg, PhD 631-638-1931 fred.friedberg@stonybrookmedicine.edu

Locations
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United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794-8101
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Fred Friedberg, PhD Stony Brook University
  Study Documents (Full-Text)

Documents provided by Stony Brook University:
Study Protocol  [PDF] September 21, 2017
Informed Consent Form  [PDF] October 4, 2017
Statistical Analysis Plan  [PDF] October 10, 2017


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Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT03331419     History of Changes
Other Study ID Numbers: 3R01NR015850-02S1 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fatigue
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases