Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07304167
Eligibility Criteria:
Inclusion Criteria:
* Women aged between 30 and 70 years, which is an age range in which fibromyalgia (FM) is more prevalent;
* Having a diagnosis of fibromyalgia;
* Being willing to participate in the study and signing the informed consent form;
* Meeting the 2016 American College of Rheumatology (ACR) diagnostic criteria, defined as a Widespread Pain Index (WPI) ≥ 7 and a Symptom Severity Scale (SSS) score ≥ 5, or WPI = 4-6 and SSS ≥ 9.
Exclusion Criteria:
* Pregnancy or breastfeeding
* Any known advanced pathology related to the locomotor system that contraindicates physical activity (such as arthritis, osteoarthritis, or uric acid disorders)
* Epilepsy
* History of severe headache
* Neurological disorder
* Peripheral neuropathy
* Known severe cardiovascular disease (such as endocranial hypertension, uncontrolled arterial hypertension, heart failure, or presence of a pacemaker)
* Orthopedic disorders of the upper or lower extremities that prevent participation in physical activity
* Rheumatologic disease other than fibromyalgia
* Pneumothorax
* Neoplasia
* Surgery within the last four months
* Severe psychiatric illness (such as uncontrolled depression and anxiety, personality disorders, dementia, or cognitive impairments related to substance abuse)
* Diagnosis of alcohol dependence or use of psychoactive drugs or narcotics
* Participation in any physical activity program within two months prior to the start of the study
* Body mass index (BMI) greater than 29.9
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT07304167
Study Brief:
Protocol Section:
NCT07304167