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

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ClinicalTrials.gov Identifier: NCT03675087
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Hospital Universitario La Paz
Information provided by (Responsible Party):
Susana García Juez, Escuela Universitaria de Fisioterapia de la Once

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.


Condition or disease
Fatigue Syndrome, Chronic

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mean Value of the Peak VO2 in both Exercise Tests (6MWT and Peak CPET) in Milillitres/ Minute. [ Time Frame: 3 hours one day and 2 hours another day. ]
    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.


Secondary Outcome Measures :
  1. Mean Age of Participants in Years. [ Time Frame: 5 minutes. ]
    It will be measured with the date of birth, collected by data collection sheet. Mean and standard deviation will be calculated.

  2. Percentage of Males and Females. [ Time Frame: 5 minutes. ]
    It will be collected by data collection sheet. The percentage by gender will be calculated.

  3. Percentage of Participants´ Professions. [ Time Frame: 5 minutes. ]
    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.

  4. Mean of Time of Evolution of the Disease in Years. [ Time Frame: 5 minutes. ]
    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.

  5. Percentage of Participants with Autonomic Dysfunction. [ Time Frame: 5 minutes. ]
    Options yes or not, presence of orthostatic postural tachycardias and/or alterations in the Heart Rate Variability. It will be collected by data collection sheet. Percentage of participants with or without autonomic dysfunction will be calculated.

  6. Percentage of Medications Intake. [ Time Frame: 10 minutes. ]
    The type of medications consumed is an open field. It will be collected by data collection sheet. Percentage by name of medication will be calculated.

  7. Mean of Weight in Kilograms. [ Time Frame: 5 minutes. ]
    It will be measured with the Pesperson precision scale. Range 200 grams-160 kilograms. Sensitivity 100 grams. Mean and standard deviation will be calculated.

  8. Mean of Height in Meters. [ Time Frame: 5 minutes. ]
    It will be measured with the Pesperson tape height meter, range 82-200cm. Sensitivity 1mm. Mean and standard deviation will be calculated.

  9. Mean of Body Mass Index in Kilograms/ Meters^2. [ Time Frame: 5 minutes. ]
    It is calculated by dividing the weight by the square of the height with the data obtained by the two previous outcomes. Mean and standard deviation will be calculated.

  10. Mean of Physical Activity Level at Baseline on ActivPAL 4 Micro. [ Time Frame: 7 days. ]
    The time that participant spends lying, sitting, standing or walking is measured 7 days, 24 hours/day before both exercise tests. It will be registered with the activity meter ActivPAL4 micro, which is validated as an instrument for detecting the activity and as a tool for estimating energy expenditure, and whose data are reproducible. Mean and standard deviation will be calculated.

  11. Mean Forced Vital Capacity (FVC) on Forced Spirometry in Milillitres. [ Time Frame: 15 minutes. ]
    It will be performed according to the American Thoracic Society protocol with three forced spirometries The portable spirometer Oxycon Mobile CPET from JaegerTM will be used for its measuring. Mean and standard deviation will be calculated.

  12. Mean Forced Expiratory Volume in the First Second (FEV1) on Forced Spirometry in Milillitres. [ Time Frame: 15 minutes. ]
    It will be performed according to the American Thoracic Society protocol with three forced spirometries. The portable spirometer Oxycon Mobile CPET from JaegerTM will be used for its measuring. Mean and standard deviation of FEV1 will be calculated.

  13. Mean Tiffeneau Index (FEV1 / FVC) on Forced Spirometry in Percentage. [ Time Frame: 15 minutes. ]
    It is calculated with the data provided by the two previous outcomes. Mean and standard deviation will be calculated.

  14. Mean Change from Baseline in Medications Dosage at After Both Exercise Tests (6MWT and Peak CPET). [ Time Frame: 10 minutes on day and 10 minutes another day. ]
    Open field, daily medications dosage consumed before and after both tests. It will be collected by data collection sheet. Mean and standard deviation of the differences in the dose intake by type of medication will be calculated.

  15. Mean Change from Baseline in Quality of Life Related to Health on SF-36v2 at After Both Exercise Tests. [ Time Frame: 20 minutes one day and 20 minutes another day. ]
    It is measured from 0 to 100 points by the SF-36v2 (internal consistency value α of Cronbach of 0.94). This instrument provides a profile of health status, it is usually used in studies of research in the international field in the SFC/EM and a validated version is available in Spanish. Mean and standard deviation of the differences in the total questionnaire score and in the subscales of the questionnaire will be calculated.

  16. Mean Change from Baseline in Multidimensional Fatigue on MIF:S at After Both Exercise Tests. [ Time Frame: 10 minutes one day and 10 minutes another day. ]
    It is measured from 4 to 20 points with the Multidimensional Inventory of Fatigue in Spanish (MIF: S) (internal consistency value α of Cronbach of 0.91). Mean and standard deviation of the differences will be calculated.

  17. Mean Change from Baseline in Physical Activity Level on ActivPAL 4 Micro at After each of the Exercise Tests. [ Time Frame: 21 days, in 3 periods of 7 days. ]
    The mean change in values of the time that participant spends lying, sitting, standing or walking is measured 7 days, 24 hours/day before both exercise tests and 7 days, 24 hours/day after the 6MWT and after the peak CPET. It will be registered with the activity meter ActivPAL4 micro, which is validated as an instrument for detecting the activity and as a tool for estimating energy expenditure, and whose data are reproducible.

  18. Mean Value of the Peak VO2 Body Weight Adjusted in 6MWT and in Peak CPET in Milillitres/ Kilograms/ Minute. [ Time Frame: 3 hours one day and 2 hours another day. ]
    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.

  19. Percentage of Exercise Tolerance. [ Time Frame: 3 hours one day and 2 hours another day. ]
    Class 1, 2, 3 or 4, classification of the impairment in exercise tolerance of the American Medical Association that is based on the values of percentage of peak VO2 body weight adjusted achieved during the exercise tests in accordance with the values of overall population. Percentage of participants in each class will be calculated.

  20. Mean Distance on the 6MWT in Metres. [ Time Frame: 3 hours. ]
    It will be obtained by the 6MWT with the American Thoracic Society protocol. Mean and standard deviation will be calculated.

  21. Mean Peak Work Load on the Peak CPET in Watts. [ Time Frame: 2 hours. ]
    It is measured through the Jaeger 900 cycle ergometer during the peak CPET with Snell CR. et al protocol. Mean and standard deviation of participants´ peak work load will be calculated.

  22. Mean Change from Baseline in O2 Saturation on Spirometer at After each of the Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It is measured in percentage with a portable spirometer Oxycon Mobile CPET of JaegerTM in the 6MWT or with a fixed spirometer Mijnhart Oxycon in the peak CPET. Mean and standard deviation will be calculated.

  23. Mean Change from Baseline in Heart Rate on Pulsiometer or Electrocardiogram at Maximum Hearth Rate in both Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It is measured in beats per minute with the heart rate sensor of the Polar TM31 band in 6MWT or with the 12-lead JaegerTM ECG in the peak CPET. Mean and standard deviation will be calculated.

  24. Mean Change from Baseline in Heart Rate on Pulsiometer or Elecrocardiogram at After each of the Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It is measured in beats per minute with the heart rate sensor of the Polar TM31 band in the 6MWT or with the 12-lead JaegerTM ECG in the peak CPET. Mean and standard deviation of the differences in hearth rate between baseline and after the 6MWT or peak CPET will be calculated.

  25. Mean Change from Baseline in Blood Pressure on Tensiometer at After each of the Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It is measured in mmHg with Suntech Oscar 2 tensionmeter in the 6MWT or Riester tensionmeter in the peak CPET. Mean and standard deviation will be calculated.

  26. Mean Change from Baseline in Total Heart Rate Variability on Pulsiometer or Electrocardiogram at After each of the Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It will be measured in milliseconds, standard deviation of all the variations in the time interval between heartbeats measured with the heart rate sensor of the TM31 Polar band in the 6MWT or with the 12-lead JaegerTM ECG in the peak CPET. Mean and standard deviation will be calculated.

  27. Mean of the Maximum Heart Rate in Percentage. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It will be calculated with the value of the maximum heart rate reached and the maximum theoretical heart rate (220-patient's age) in the 6MWT and in the peak CPET. Mean and standard deviation will be calculated.

  28. Mean Change from Baseline in VO2 on Spirometer at the Peak VO2 of the 6MWT and the Peak CPET. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It is measured in millilitres/ minute with a portable spirometer Oxycon Mobile CPET of JaegerTM in the 6MWT or with a fixed spirometer Mijnhart Oxycon in the peak CPET. Mean and standard deviation will be calculated.

  29. Mean Change from Baseline in VO2 Body Weight Adjusted on Spirometer at the Peak VO2 of both Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It is measured in millilitres/ minute /kilograms with a portable spirometer Oxycon Mobile CPET of JaegerTM in the 6MWT or with a fixed spirometer Mijnhart Oxycon in the peak CPET. Mean and standard deviation will be calculated.

  30. Mean Change from Baseline in Oxygen Pulse on Spirometer at the Peak VO2 of both Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It will be measured in millilitre/ cycle with a portable spirometer Oxycon Mobile CPET of JaegerTM in the 6MWT or with a fixed spirometer Mijnhart Oxycon in the peak CPET. Mean and standard deviation in differences in oxygen pulse at baseline and at peak VO2 in both exercise tests will be calculated.

  31. Mean Change from Baseline in CO2 Production on Spirometer at the Peak VO2 of both Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It will be measured in millilitre/ min with a portable spirometer Oxycon Mobile CPET of JaegerTM in the 6MWT or with a fixed spirometer Mijnhart Oxycon in the peak CPET. Mean and standard deviation in differences in CO2 production between baseline and peak VO2 in both exercise tests will be calculated.

  32. Mean Change from Baseline in Respiratory Exchange Ratio (RER) at the Peak VO2 of both Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It will be measured in millilitres/ minute, is calculated with the values of O2 consumption and CO2 production before tests and at peak VO2 of both exercise tests. Mean and standard deviation will be calculated.

  33. Mean Change from Baseline in Minute Ventilation at the Peak VO2 of both Exercise Tests. [ Time Frame: 3 hours one day and 2 hours another day. ]
    It will be measured in litres/ minute with a portable spirometer Oxycon Mobile CPET of JaegerTM in the 6MWT or with a fixed spirometer Mijnhart Oxycon in the peak CPET. Mean and standard deviation of differences between baseline and at peak VO2 of both exercise tests will be calculated.



Information from the National Library of Medicine

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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
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, 2019 and that fulfill the inclusion criteria and do not present any exclusion criteria.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%
    • Acute renal failure
    • Untreated thyrotoxicosis
    • Acute infection
    • Uncontrolled hypertension (greater than 200-120 mmHg)
    • Hypertrophic obstructive cardiomyopathy
    • High-grade atrioventricular block
    • Significant pulmonary arterial hypertension
    • Advanced or risky pregnancy
    • Significant diselectrolithmia
    • Severe symptomatic aortic stenosis
    • Severe anemia
    • Pulmonary embolism
    • Acute thrombophlebitis
    • Traumatologic, orthopedic or neurological pathology that does not allow to walk or cycling.
    • Psychic incapacity to understand the instructions of the tests.
  • Present comorbidity of Multiple Chemical Sensitivity Syndrome.
  • Have performed the peak incremental CPET in the last 3 years.

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): NCT03675087


Contacts
Contact: Susana García-Juez, Lecturer 915894500 ext 4353 sgj@once.es
Contact: Irene Rodríguez-Andonaegui, Lecturer 915894500 ext 4376 irra@once.es

Locations
Spain
Escuela Universitaria de Fisioterapia de la ONCE
Madrid, Spain, 28034
Sponsors and Collaborators
Escuela Universitaria de Fisioterapia de la Once
Hospital Universitario La Paz
Investigators
Study Chair: Ana B Varas-de-la-Fuente, Chair Escuela Universitaria de Fisioterapia de la Once
Principal Investigator: Susana García-Juez Escuela Universitaria de Fisioterapia de la Once
  Study Documents (Full-Text)

Documents provided by Susana García Juez, Escuela Universitaria de Fisioterapia de la Once:
Informed Consent Form  [PDF] August 20, 2018


Publications of Results:
Javierre C, Alegre J, Ventura JL, García-Quintana A, Segura R, Suarez A, et al. Physiological Responses to Arm and Leg Exercise in Women Patients with Chronic Fatigue Syndrome. Journal of Chronic Fatigue Syndrome. 2007;14(1):43-53.
Make B, Jones JF. Impairment of patients with chronic fatigue syndrome. J Chronic Fatigue Syndr. 1997;3(4):43-56.

Other Publications:
Bennett RM. Fibromyalgia and chronic fatigue syndrome. In: Goldman L, Ausiello DA, eds. Cecil Medicine. 23rd ed. Philadelphia, Pa: Saunders Elsevier; 2007. Chapter 295.
World Health Organization. International statistical classification of diseases and related health problems. 10th revision. Fifth edition. 2016. [internet]. Ginebra: World Health Organization; 2016. In: http://apps.who.int/classifications/icd10/browse/2016/en.
Engleberg N. Síndrome de fatiga crónica. En: Mandell GL, Bennett JE, Dolin R, editores, Douglas RG, colaborador. Mandell, Douglas, y Bennett. Enfermedades Infecciosas: principios y práctica. 5ª ed. Buenos Aires: Ed. Panamericana, 2002. p.1871-1877.
Turnbull N, Shaw EJ, Baker R, Dunsdon S, Costin N, Britton G, et al. National Institute for Health and Clinical Excellence. Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management of CFS/ME in adults and children. London: Royal College of General Practitioners; 2007. In: http://guidance.nice.org.uk/CG053
Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Board on the Health of Select Populations; Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Redefining an Illness. Washington (DC): National Academies Press (US); 2015.
Carruthers BM, Jain AK, DeMeirleir KL, Peterson DL, Klimas NG, Lerner AM, et al. Myalgic Encephalomyelitis/chronic fatigue syndrome: Clinical working case definition, diagnostic and treatments protocols. Journal of Chronic Fatigue Syndrome. 2003;11:7-115.
Jason L, Evans M, Porter N, Brown M, Brown A, Hunnell J, et al. The development of a revised Canadian myalgic encephalomyelitis chronic fatigue syndrome case definition. Am J Biochem Biotechnol. 2010;6(2):120-135
Mulrow CD, Ramirez G, Cornell JE, Allsup J. Defining and managing chronic fatigue syndrome. Rockville, MD: Agency for Healthcare Research and Quality (US); 2001.
American Medical Association. Guides to the evaluation of permanent impairment. 5ª ed. Chicago: American Medical Association; 2001.
Klimas N, Patarca R. Disability and chronic fatigue syndrome: clinical, legal and patient perspectives. Binghamton NY: Haworth Medical Press; 1997.
Ciccolella ME, Boone T, Davenport T. Part II. Legal aspects of aerobic capacity: objective evidence of the ability to work. PEPonline. 2011 septiembre; 14 (9): 11. In: https://www.asep.org/asep/asep/Part%20II%20Legal%20MARGARET%20CICCOLELLA.pdf.
American Thoracic Society Committee in Proficiency Standars for Pulmonary Function Laboratories: Standarization of Spirometry- 1987 update. Am Rev Respir Dis. 1981; 136:1299-1307.

Responsible Party: Susana García Juez, 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., Escuela Universitaria de Fisioterapia de la Once
ClinicalTrials.gov Identifier: NCT03675087     History of Changes
Other Study ID Numbers: 1
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susana García Juez, Escuela Universitaria de Fisioterapia de la Once:
Work Capacity Evaluation
Fatigue Syndrome,Chronic
Exercise Tests

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Encephalomyelitis
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections