Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.

NCT03675087 | Recruiting

• 1 other identifier: 1
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the correlation between the 6-min walking test (6MWT) with gases measurement, and the peak cardiopulmonary exercise testing (CPET) using incremental cycling with gases and workload measurement, in order to determine if the 6MWT detects impairment in exercise tolerance and if it avoids the post-exertional malaise that the peak CPET causes on decreasing levels of physical activity, in participants affected by chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME). Physical activity level at baseline (usual activity, the parcipant will not be given any directions) will be recorded during 7 days, 24 hours/day. Afterwards, the 6MWT will be performed. After this test, the physical activity level will be collected again during 7 days, 24 hours/day. Peak CPET will be carried out 14 days after 6MWT to make sure that the basal levels are recovered, and finally, physical activity level will be collected again during 7 days, 24 hours/day.

Conditions

Fatigue Syndrome, Chronic

Keywords

Work Capacity Evaluation; Fatigue Syndrome,Chronic; Exercise Tests

Outcome Measures

Primary Outcomes (1)

• Mean Value of the Peak VO2 in both Exercise Tests (6MWT and Peak CPET) in Milillitres/ Minute.

  The portable spirometer Oxycon Mobile CPET from JaegerTM during 6MWT or the fixed spirometer Mijnhart Oxycon during peak CPET will be used for its measuring. Those instruments are validated. Mean and standard deviation will be calculated.

  3 hours one day and 2 hours another day.

Secondary Outcomes (33)

• Mean Age of Participants in Years.

  5 minutes.

• Percentage of Males and Females.

  5 minutes.

• Percentage of Participants´ Professions.

  5 minutes.

• Mean of Time of Evolution of the Disease in Years.

  5 minutes.

• Percentage of Participants with Autonomic Dysfunction.

  5 minutes.

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

Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis affected and derived by their specialist in internal medicine from Hospital Universitario La Paz or by the Asociación de Afectados por el Síndrome de Fatiga Crónica y el Síndrome de Sensibilidad Química Múltiple de la Comunidad de Madrid, to the Escuela Universitaria de Fisioterapia de la ONCE and to the Department of Functional Tests of the Pneumology Service of the Hospital Universitario La Paz, Madrid (Spain) from October 1st, 2018 to July 1st, 2025 and that fulfill the inclusion criteria and do not present any exclusion criteria.

You may qualify if:

• To be diagnosed by a medical specialist in internal medicine with experience in this disease. For this, the participant must fulfill with the diagnostic criteria of CFS/ME, following the recommended criteria for the diagnosis of 2015.
• Prior signing of the informed consent.

You may not qualify if:

• Present any of the diagnoses considered excluding of the CFS/ME, according to the international criteria recommended for clinical diagnosis and the selection of subjects for research:
• Primary psychiatric disorders
• Somatoform disorders
• or Substance abuse
• Present any of the absolute or relative contraindications, to perform exercise tests, described in previous investigations:
• Decompensated heart failure
• Acute myocardial infarction (less than 3 days)
• Syncope
• Unstable angina
• Cardiac arrhythmia poorly controlled
• Endocarditis, myocarditis or acute pericarditis
• Acute pulmonary edema
• Moderate or severe cardiac valvular stenosis
• Suspected dissection or dissecting aortic aneurysm
• O2 saturation at rest less than 85%

Sponsors & Collaborators

• Escuela Universitaria de Fisioterapia de la Once: lead
• Hospital Universitario La Paz: collaborator

Study Sites (1)

Escuela Universitaria de Fisioterapia de la ONCE

Madrid, 28034, Spain

RECRUITING

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  RESULT

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• Munguia-Izquierdo D, Segura-Jimenez V, Camiletti-Moiron D, Pulido-Martos M, Alvarez-Gallardo IC, Romero A, Aparicio VA, Carbonell-Baeza A, Delgado-Fernandez M. Multidimensional Fatigue Inventory: Spanish adaptation and psychometric properties for fibromyalgia patients. The Al-Andalus study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):94-102. Epub 2012 Dec 14.

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  RESULT

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

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

Study Officials

• Ana B Varas-de-la-Fuente, Chair

  Escuela Universitaria de Fisioterapia de la Once

  STUDY CHAIR

• Susana García-Juez

  Escuela Universitaria de Fisioterapia de la Once

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana García-Juez, Lecturer

CONTACT

915894500; sgj@once.es

Irene Rodríguez-Andonaegui, Lecturer

CONTACT

915894500; irra@once.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate. Master´s degree in physiotherapy. Postgraduate and degree lecturer of Escuela Universitaria de Fisioterapia de la ONCE. Physioterapist practice in a private clinic.

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 18, 2018
• Study Start: February 27, 2019
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)