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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT05884034
Eligibility Criteria:
Inclusion Criteria:
* Informal caregiver (i.e., family member, friend, or a caregiver without payment) of an individual with ALS (clinically defined, probable, or possible) diagnosed by a neurologist using the (El Escorial Criteria);
* Informal caregiver of people who did not have any other neurological disease associated with ALS;
* Aged 18 years or above;
* Without cognitive impairment on the Mini-Mental State Examination (MMSE; cutoff point of 25 for literate individuals) for understanding the study and the informed consent form;
* Literate (at least complete primary education).
Exclusion Criteria:
* Health conditions that hinder from exercising safely, such as recent surgeries, fractures; uncontrolled heart, vascular and respiratory disorders; dizziness or vertigo, fainting; oncological diseases; neurological diseases that affect balance and protective reactions;
* Caregivers in the first trimester of pregnancy, due to the risk of the sudden increase in resting heart rate;
* Using psychiatric medication, such as anxiolytics, antidepressants, antipsychotics, and antiepileptics, as the use of these medications may interfere with the results of this study;
* Drop out of two or more consecutive days without replacement
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05884034
Study Brief:
Protocol Section:
NCT05884034