Exercise-related Post-exertional Malaise

NCT03331419 | Unknown

• 1 other identifier: 3R01NR015850-02S1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  The time and frequency variation in heart rate recorded on a portable heart monitor

  15 days

Secondary Outcomes (4)

• Six minute walk distance (m)

  24 hours

• Blood pressure

  24 hours

• Physical activity

  15 days

• Online web diary

  15 days

Study Arms (2)

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

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

Interventions

Exercise test BEHAVIORAL

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

Females with Chronic Fatigue Syndrome; Males with Chronic Fatigue Syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794-8101, United States

Location

Related Publications (1)

• 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.

  PMID: 37012343 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Fred Friedberg, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Bruckenthal, PhD

CONTACT

631-444-1172; patricia.bruckenthal@stonybrook.edu

Fred Friedberg, PhD

CONTACT

631-638-1931; fred.friedberg@stonybrookmedicine.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: November 6, 2017
• Study Start: November 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)