None listed
Conditions
Brief summary
Provide innovative information on the temporal relationship of physiological responses (oxygen consumption, carbon dioxide production, anaerobic threshold, cardiac output, heart rate, power output, and blood pressure), inflammation and cognitive functioning in CFS/ME patients following repeated cardiopulmonary exercise testing at 48 and 72 hours. Design: Randomised controlled trial with CFS/ME randomised to either 48 or 72 hour repeat testing and age matched healthy controls. Recruitment: Participants will be recruited through the national organisation (ANZMES) via flyers and mail out to patients as well as identified through a database of existing CFS/ME from previous studies. Upon making contact and showing interest potential participants complete the online De Paul Symptom Questionnaire. This will be analysed to ensure participants meet the CFS International, Canadian and Fukuda criteria for diagnosis of CFS. Participants: 60 participants will be recruited, 30 CFS/ME, and 30 matched healthy controls will be recruited. Testing will take place in Massey University's Exercise and Sport Science mobile lab. Individuals will be matched with control subjects for age, body mass and activity levels and will be free from non-communicable diseases. All participants will give written informed consent. Pre-exercise measures: All individuals will undergo endothelial function assessment by pulse wave velocity and analysis (via SphygmaCor). Individuals will then provide a 20ml venous blood sample (cytokine assessment). Following this, individuals will have their resting blood pressure, height and weight recorded and heart rate variability measured. Individuals will then undertake neuropsychological testing via the stroop, trail, substitution and choice tests to test their pre exercise cognitive function. Exercise testing: A validated incremental cycle ergometer exercise test designed to peak at work rates in 8-12 minutes. Participants will maintain 60-80 rpm throughout the test and will be encouraged to participate for as long as possible. The workload will be increased at a rate of 5 watts/20 second. Breath by breath gas samples will be collected throughout the exercise test via metabolic cart. Participants will then remain seated on the cycle ergometer and monitored for 2-5 minutes for recovery. Heart rate and rating of perceived exertion will be measured during each minute of the test and blood pressure manually every two minutes. Following a 20-minute period of rest, cardiac output will be measured through a non-invasive rebreathing technique and will require participants to cycle for up to five minutes at a set resistance at their respiratory exchange ratio. Post-exercise measures: Exercise recovery questionnaire as used by Davenport et al., 2010 will be completed. This allows participants to report symptoms following their exercise test, until complete recovery. We will record symptoms of fatigue each 24 hours for 7 days
Interventions
Pre-exercise measures: All individuals will undergo endothelial function assessment by pulse wave velocity and analysis (via SphygmaCor). Individuals will then provide a 20ml venous blood sample (cytokine assessment). Following this, individuals will have their resting blood pressure, height and weight recorded and heart rate variability measured. Individuals will then undertake neuropsychological testing via the stroop, trail, substitution and choice tests to test their pre exercise cognitive f
Pre-exercise measures: All individuals will undergo endothelial function assessment by pulse wave velocity and analysis (via SphygmaCor). Individuals will then provide a 20ml venous blood sample (cytokine assessment). Following this, individuals will have their resting blood pressure, height and weight recorded and heart rate variability measured. Individuals will then undertake neuropsychological testing via the stroop, trail, substitution and choice tests to test their pre exercise cognitive function. Exercise testing: A validated incremental cycle ergometer exercise test designed to peak at work rates in 8-12 minutes. Participants will maintain 60-80 rpm throughout the test and will be encouraged to participate for as long as possible. The workload will be increased at a rate of 5 watts/20 second. Breath by breath gas samples will be collected throughout the exercise test via metabolic cart. Participants will then remain seated on the cycle ergometer and monitored for 2-5 minutes for recovery. Heart rate and rating of perceived exertion will be measured during each minute of the test and blood pressure manually every two minutes. Following a 20-minute period of rest, cardiac output will be measured through a non-invasive rebreathing technique and will require participants to cycle for up to five minutes at a set resistance at their respiratory exchange ratio. Post-exercise measures: Exercise recovery questionnaire as used by Davenport et al., 2010 will be completed. This allows participants to report symptoms following their exercise test, until complete recovery. We will record symptoms of fatigue each 24 hours for 7 days. 48 or 72 hours later - Individuals will repeat all tests after either 48 or 72 hours.
Sponsors
Massey University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
CFS/ME individuals will need to meet the International Consensus Criteria, Canadian Criteria and Fukuda case definition. These involve 3 major inclusion points, >6 months of severe fatigue, significant reductions in day to day functionality and the presence of 4 out of 8 major symptoms. Healthy volunteers will be age, gender and fitness match and will be free from disease.
Exclusion criteria
Depressive disorders, individuals who have a known disease unrelated to Chronic Fatigue Syndrome/ME. Healthy volunteers will be free from disease.
Outcome results
None listed