Actively Recruiting

Age: 18Years - 65Years
All Genders
ID03675087

Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis

Led by Escuela Universitaria de Fisioterapia de la Once · Updated on 2025-03-10

22

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

E

Escuela Universitaria de Fisioterapia de la Once

Lead Sponsor

H

Hospital Universitario La Paz

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with CFS/ME by a medical specialist in internal medicine experienced with the disease
  • Meeting the 2015 recommended diagnostic criteria for CFS/ME
  • Signed informed consent prior to participation
Not Eligible

You will not qualify if you...

  • Having primary psychiatric disorders, somatoform disorders, or substance abuse
  • Having contraindications to exercise tests such as decompensated heart failure, recent heart attack, syncope, unstable angina, poorly controlled arrhythmia, or acute infections
  • Oxygen saturation at rest less than 85%
  • Uncontrolled hypertension above 200/120 mmHg
  • Advanced or risky pregnancy
  • Traumatologic, orthopedic, or neurological problems preventing walking or cycling
  • Psychiatric incapacity to understand test instructions
  • Comorbidity with Multiple Chemical Sensitivity Syndrome
  • Having performed a peak incremental CPET in the last 3 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

Escuela Universitaria de Fisioterapia de la ONCE

Madrid, Spain, 28034

Actively Recruiting

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Research Team

S

Susana García-Juez, Lecturer

I

Irene Rodríguez-Andonaegui, Lecturer

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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/7978722

The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes database.

Simon M Collin, Esther Crawley, Margaret T May...

https://pubmed.ncbi.nlm.nih.gov/21923897