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ME/CFS: Activity Patterns and Autonomic Dysfunction

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ClinicalTrials.gov Identifier: NCT02948556
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Stony Brook University

Brief Summary:
The purpose of this study is to identify daily activity patterns, negative life events and autonomic abnormalities that may be related to non-improvement in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). For both naturalistic studies and behavioral intervention trials, roughly 50% of patients report worsening or unchanged illness. The proposed four year study would be the first to look at the relation between illness non-improvement, patient activities at home and autonomic function. Our long-range goal is to identify physiological signals and activity patterns that predict non-improvement and relapse and develop a self-management program that prescribes improvement-linked behaviors and discourages non-improvement activities.

Condition or disease
Chronic Fatigue Syndrome

Detailed Description:

Given the enduring debilitation and poor quality of life in ME/CFS, this study proposes to identify important activity patterns (e.g., push-crash), negative life events and autonomic dysfunction that may be associated with non-improvement. This will be accomplished with weekly online diaries, objective measures (actigraphy, heart rate monitors) and semi-structured phone interviews. Non-improvement is a rarely studied, but commonly reported outcome in this illness. For both naturalistic studies and behavioral intervention trials, roughly 50% of ME/CFS patients report worsening or unchanged illness. Also, the patient's self-management efforts may (paradoxically) produce symptom worsening and contribute to illness non-improvement. Non-improvement may also have biological relevance because activity limitations and sleep disruption in ME/CFS have both been associated with autonomic dysregulation (reduced heart rate variability). This (R01) prospective observational six month study of both daily and weekly in vivo assessments would be the first to look at non-improvement in relation to ongoing patient activities and autonomic function.

Specific Aim 1: To assess the relation between non-improvement and prospectively assessed activity patterns and life events. Hypothesis 1: Non-improvement will be significantly associated with these dimensional variables: (a) illness-exacerbating activity patterns (e.g., "push-crash") reported on home web diaries; (b) daily hassles assessed in web diaries; and (c) negative life events reported in phone interviews.

Specific Aim 2: To assess the relation between improvement and prospectively assessed activity patterns and life events. Hypothesis 2: Improvement will be significantly associated with: (a) illness-moderating activity patterns (e.g., healthy pacing) reported on home web diaries; (b) daily uplifts assessed in web diaries; and (c) positive life events assessed in phone interviews.

Specific Aim 3: To assess the relation between activity patterns and symptoms. Hypothesis 3: (a) the "push-crash" pattern will predict greater actigraphy variability and symptom variability; (b) the "limiting activity" pattern will be associated with very low actigraphy counts and high symptom severity; and (c) a healthier "pacing" pattern will be associated with moderate variability of actigraphy and symptoms.

Our secondary aim hypothesizes that autonomic dysregulation (reduced heart rate variability [HRV]) will be characteristic of both non-improvers and patients with a limiting activity pattern as compared to improvers and those with a healthy pacing pattern. The long-range goal is to develop a new self-management protocol that more clearly identifies non-improvement activities and how they can be changed. An important aspect of this new self-management protocol would be to identify early signals of impending relapse, particularly HRV status, via home-use portable devices that could be utilized by patients and their doctors as a warning to modify non-improvement activities, e.g., excessive activity or exercise, to prevent behavioral collapse into inactivity.


Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: ME/CFS: Activity Patterns and Autonomic Dysfunction
Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Chronic fatigue syndrome
Participants with chronic fatigue syndrome



Primary Outcome Measures :
  1. Global Impression of Change Rating [ Time Frame: six months ]
    Validated Self-report rating via interview



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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
Patients with a diagnosed chronic fatigue syndrome
Criteria

Inclusion Criteria:

Fukuda-based ME/CFS symptoms including:

  • six months of unexplained, debilitating fatigue
  • 4/8 secondary symptoms impaired memory or concentration unrefreshing sleep sore throats headache muscle pain joint pain tender lymph nodes post-exertional malaise

Exclusion Criteria:

Medical: fatigue clearly attributable to self-report medical conditions.

Psychiatric any psychosis alcohol/ substance abuse within two years prior or after illness onset. depression with melancholic/psychotic features within 5 years of onset .

Two other exclusionary criteria:

  • patients not dose-stabilized for at least 3 months on antidepressants ;
  • patients at risk of suicide or 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): NCT02948556


Contacts
Contact: Particia Bruckenthal, PhD, RN 631-444-1172 particia.bruckenthal@stonybrook.edu
Contact: Jenna Adamowicz, MA 631-371-4417 jenna.adamowicz@stonybrook.edu

Locations
United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794-8101
Contact: Patricia Bruckenthal, PhD, RN    631-444-1172    patricia.bruckenthal@stonybrook.edu   
Contact: Jenna Adamowicz, MA    631-371-4417    jenna.adamowicz@stonybrook.edu   
Principal Investigator: Fred Friedberg, PhD         
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Fred Friedberg, PhD Stony Brook University

Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT02948556     History of Changes
Other Study ID Numbers: 1R01NR015850-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Autonomic Nervous System Diseases
Primary Dysautonomias
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases