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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT04041193
Eligibility Criteria:
Inclusion criteria:
1. agreement to participate, with the signature of the informed consent form.
2. availability of a caregiver/study partner, who agrees to support the participant through the SIDERA\^B program.
3. living in one's own home.
4. clinical diagnosis of Chronic Heart Failure (CHF) and
1. functional New York Heart Association (NYHA) class II and III with an Ejection Fraction (EF) ≤ 40%
2. etiology of CHF primitive or post-ischemic.
5. clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and
1. COPD diagnosis according to the American Thoracic Society (ATS) and the European Respiratory Society (ERS) criteria with FEV1/FVC ratio \<70%
2. presence of airway limitation according to ATS/ERS and GOLD criteria.
6. clinical diagnosis of Parkinson Disease (PD) and
1. PD diagnosis according to the MDS criteria (Postuma et al., 2015)
2. staging between 1.5 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004)
7. age between 18 and 85 years.
Exclusion Criteria:
1. presence of comorbidities that may prevent you from undertaking a secure home program or determining clinical instability (i.e. severe orthopedic or severe cognitive deficits).
2. presence of risk conditions for safety under strain in patients with CHF (i.e. severe symptomatic aortic stenosis, evidence of ischemia due to minimal/low-intensity efforts).
3. COPD patients who do not need rehabilitation treatment (GOLD 1 / A class) or with severe COPD (GOLD 4 / D class)
4. COPD patients with overlap with other respiratory diseases or not in treatment or in the absence of good ventilatory compensation in the last 6 months
5. COPD with global respiratory failure with PaCO2\> 55 mmHg
6. PD patients with other neurological pathologies or with severe psychiatric complications
7. pathological score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test \<17.54; Conti et al., 2015).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04041193
Study Brief:
Protocol Section:
NCT04041193