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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorEscuela Universitaria de Fisioterapia de la Once

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Primary psychiatric disorders

Somatoform disorders

or Substance abuse

Decompensated heart failure

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
3 hours one day and 2 hours another day.

Secondary outcomes

1

Mean Age of Participants in Years.

It will be measured with the date of birth, collected by data collection sheet. Mean and standard deviation will be calculated.

Time frame
5 minutes.
2

Percentage of Males and Females.

It will be collected by data collection sheet. The percentage by gender will be calculated.

Time frame
5 minutes.
3

Percentage of Participants´ Professions.

Profession is an open field, works, with or without salary. It will be collected by data collection sheet. The percentage by profession will be calculated.

Time frame
5 minutes.
4

Mean of Time of Evolution of the Disease in Years.

It will be measured from the date of medical diagnosis. It will be collected by data collection sheet. Mean and standard deviation will be calculated.

Time frame
5 minutes.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Escuela Universitaria de Fisioterapia de la Once

Lead sponsor

Hospital Universitario La Paz

Collaborator