Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Mean Value of the Peak VO2 in both Exercise Tests (6MWT and Peak CPET) in Milillitres/ Minute.
研究概览
简要总结
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.
详细描述
Chronic fatigue syndrome/ myalgic encephalomyelitis presents with a significant deterioration of functional capacity, which seriously affects the quality of life. The peak or maximal incremental CPET is considered valid for the evaluation of exercise tolerance of those affected by CFS/ME, but its performance causes worsening of its symptomatology, decreasing its physical activity level after the test. It has not been verified whether the 6MWT (submaximal exercise test) with gases measurement is able to assess the exercise tolerance of those affected by SFC/EM without increasing their symptoms. So far, only the correlation between another submaximal test and a peak CPET in two different groups of participants have been analyzed and proven, which it makes necessary to check adequately whether there is a correlation by performing both tests on the same participants. In addition, it is necessary to compare the degree of worsening in physical activity level that both tests produce in participants, because they have not been objectively evaluated in any previous study. It could be useful to have a more innocuous and simple test for the assessment of exercise tolerance in CFS/ME in clinical practice, in order to evaluate the benefits of treatments like rehabilitation programs. 6MWT could respond to these characteristics because it reaches an identical value in peak VO2 than in the peak CPET in other pathologies and it generates less physical stress.
This research will be developed with the utmost respect for individual human rights, according to the postulates accepted internationally by the United Nations and the European Commission (Helsinki Act of 1964 and the Oviedo Convention of 1997) and Regulation (EU) 2016/679 of the European Parliament and the Council of April 27, 2016 on Data Protection (RGPD).
Participation in this study is entirely voluntary and does not imply any risk to health. Participants are entitled to refuse to participate or to leave the study at any time they choose.
All information will be treated confidentially. If it is decided to publish the results of the study, in these publications will not include individual data or the names of the participants, only information considered globally will be included.
This study has been approved in August 2018 by the Ethics and Research Committee of the La Paz University Hospital in Madrid (HULP Code: PI-3320).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Prior signing of the informed consent.
排除标准
- •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)
- •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.
结局指标
主要结局
Mean Value of the Peak VO2 in both Exercise Tests (6MWT and Peak CPET) in Milillitres/ Minute.
时间窗: 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.
次要结局
- Mean of Time of Evolution of the Disease in Years.(5 minutes.)
- Mean Tiffeneau Index (FEV1 / FVC) on Forced Spirometry in Percentage.(15 minutes.)
- Mean Change from Baseline in Medications Dosage at After Both Exercise Tests (6MWT and Peak CPET).(10 minutes on day and 10 minutes another day.)
- Mean Change from Baseline in Multidimensional Fatigue on MIF:S at After Both Exercise Tests.(10 minutes one day and 10 minutes another day.)
- Mean of the Maximum Heart Rate in Percentage.(3 hours one day and 2 hours another day.)
- Mean Change from Baseline in VO2 on Spirometer at the Peak VO2 of the 6MWT and the Peak CPET.(3 hours one day and 2 hours another day.)
- Mean Age of Participants in Years.(5 minutes.)
- Percentage of Participants´ Professions.(5 minutes.)
- Percentage of Participants with Autonomic Dysfunction.(5 minutes.)
- Percentage of Medications Intake.(10 minutes.)
- Mean of Weight in Kilograms.(5 minutes.)
- Mean Forced Vital Capacity (FVC) on Forced Spirometry in Milillitres.(15 minutes.)
- Mean Change from Baseline in Quality of Life Related to Health on SF-36v2 at After Both Exercise Tests.(20 minutes one day and 20 minutes another day.)
- Percentage of Males and Females.(5 minutes.)
- Mean Change from Baseline in Oxygen Pulse on Spirometer at the Peak VO2 of both Exercise Tests.(3 hours one day and 2 hours another day.)
- Mean Change from Baseline in CO2 Production on Spirometer at the Peak VO2 of both Exercise Tests.(3 hours one day and 2 hours another day.)
- Mean Change from Baseline in Respiratory Exchange Ratio (RER) at the Peak VO2 of both Exercise Tests.(3 hours one day and 2 hours another day.)
- Mean of Height in Meters.(5 minutes.)
- Mean of Body Mass Index in Kilograms/ Meters^2.(5 minutes.)
- Mean of Physical Activity Level at Baseline on ActivPAL 4 Micro.(7 days.)
- Mean Forced Expiratory Volume in the First Second (FEV1) on Forced Spirometry in Milillitres.(15 minutes.)
- Mean Value of the Peak VO2 Body Weight Adjusted in 6MWT and in Peak CPET in Milillitres/ Kilograms/ Minute.(3 hours one day and 2 hours another day.)
- Mean Distance on the 6MWT in Metres.(3 hours.)
- Mean Change from Baseline in Heart Rate on Pulsiometer or Elecrocardiogram at After each of the Exercise Tests.(3 hours one day and 2 hours another day.)
- Mean Change from Baseline in Physical Activity Level on ActivPAL 4 Micro at After each of the Exercise Tests.(21 days, in 3 periods of 7 days.)
- Percentage of Exercise Tolerance.(3 hours one day and 2 hours another day.)
- Mean Peak Work Load on the Peak CPET in Watts.(2 hours.)
- Mean Change from Baseline in O2 Saturation on Spirometer at After each of the Exercise Tests.(3 hours one day and 2 hours another day.)
- Mean Change from Baseline in Heart Rate on Pulsiometer or Electrocardiogram at Maximum Hearth Rate in both Exercise Tests.(3 hours one day and 2 hours another day.)
- Mean Change from Baseline in Blood Pressure on Tensiometer at After each of the Exercise Tests.(3 hours one day and 2 hours another day.)
- Mean Change from Baseline in Total Heart Rate Variability on Pulsiometer or Electrocardiogram at After each of the Exercise Tests.(3 hours one day and 2 hours another day.)
- Mean Change from Baseline in VO2 Body Weight Adjusted on Spirometer at the Peak VO2 of both Exercise Tests.(3 hours one day and 2 hours another day.)
- Mean Change from Baseline in Minute Ventilation at the Peak VO2 of both Exercise Tests.(3 hours one day and 2 hours another day.)
研究者
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