ME/CFS: Activity Patterns and Autonomic Dysfunction
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|ClinicalTrials.gov Identifier: NCT02948556|
Recruitment Status : Unknown
Verified November 2016 by Stony Brook University.
Recruitment status was: Recruiting
First Posted : October 28, 2016
Last Update Posted : November 3, 2016
|Condition or disease|
|Chronic Fatigue Syndrome|
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|
|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|
Chronic fatigue syndrome
Participants with chronic fatigue syndrome
- Global Impression of Change Rating [ Time Frame: six months ]Validated Self-report rating via interview
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
|Contact: Particia Bruckenthal, PhD, RNfirstname.lastname@example.org|
|Contact: Jenna Adamowicz, MAemail@example.com|
|United States, New York|
|Stony Brook University||Recruiting|
|Stony Brook, New York, United States, 11794-8101|
|Contact: Patricia Bruckenthal, PhD, RN 631-444-1172 firstname.lastname@example.org|
|Contact: Jenna Adamowicz, MA 631-371-4417 email@example.com|
|Principal Investigator: Fred Friedberg, PhD|
|Principal Investigator:||Fred Friedberg, PhD||Stony Brook University|