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:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT01650818
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of definite ALS, probable ALS, or probable-laboratory supported ALS according to the El Escorial criteria or diagnosis of progressive muscular atrophy.
* Ability to perform a baseline symptom-limited cardiopulmonary exercise test with attainment of peak power and respiratory exchange ratio of \>= 50 W and \>= 1.00, respectively.
* Time since symptoms onset \<= 18 months.
* Forced vital capacity \>= 70% of predicted.
* Informed written consent.
Exclusion Criteria:
* Coexisting neurological disease.
* Coexisting extra-neurological disease significantly affecting exercise capacity.
* Coexisting malignancy.
* Ongoing/planned pregnancy.
* Involvement in formal endurance and/or strength training program.
* Enrolment in any other clinical trial.
* Cognitive impairment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01650818
Study Brief:
Protocol Section:
NCT01650818