The chronic fatigue syndrome: a comprehensive approach to its definition and study. International Chronic Fatigue Syndrome Study Group.
K Fukuda, S E Straus, I Hickie...
https://pubmed.ncbi.nlm.nih.gov/7978722Actively Recruiting
Led by Escuela Universitaria de Fisioterapia de la Once · Updated on 2025-03-10
22
Participants Needed
1
Research Sites
21 weeks
Total Duration
E
Escuela Universitaria de Fisioterapia de la Once
Lead Sponsor
H
Hospital Universitario La Paz
Collaborating Sponsor
Researchers are investigating exercise tolerance in people with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) by comparing two exercise tests: a 6-minute walking test (6MWT) with gas measurement and a peak cardiopulmonary exercise test (CPET) using incremental cycling. The goal is to see if the 6MWT can detect exercise impairment without causing the post-exertional malaise often triggered by the peak CPET. This study respects participants' rights and confidentiality and has ethical approval from a university hospital. Participants will have their usual physical activity recorded continuously for 7 days before performing the 6MWT. After the 6MWT, activity monitoring will continue for another 7 days. Fourteen days later, they will undergo the peak CPET, followed by a further 7 days of activity monitoring to ensure recovery from the test. The study involves detailed measurement of exercise responses and physical activity levels during these periods. Throughout the study, participants will undergo assessments including lung function tests, medication intake, quality of life, fatigue levels, heart rate, blood pressure, oxygen saturation, and various exercise performance measures. Data will be analyzed to compare the two tests' ability to evaluate exercise tolerance and their impact on physical activity. Participation lasts around 5 weeks with continuous monitoring and multiple assessments to understand exercise effects in CFS/ME.
CONDITIONS
Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 separate days, each lasting 2 to 3 hours
Participants complete two exercise tests, the 6-minute walk test (6MWT) and the peak incremental cardiopulmonary exercise test (CPET), to assess exercise tolerance and physical activity levels.
2 visits (in-person) on separate days
Duration - 3 weeks
Participants' physical activity levels are monitored using an activity tracker before and after each exercise test over several weeks to evaluate changes in activity and symptom exacerbation.
Activity monitoring over 3 periods of 7 days each
Total: 1 location
1
Escuela Universitaria de Fisioterapia de la ONCE
Madrid, Spain, 28034
Actively Recruiting
S
Susana García-Juez, Lecturer
I
Irene Rodríguez-Andonaegui, Lecturer
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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