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:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT03545958
Eligibility Criteria:
Inclusion Criteria:
* 55 years of age or older;
* Present with controlled or uncontrolled stage 1 hypertension (seated, resting clinic SBP 140 to 179 mmHg and/or DBP 90 to 109 mmHg) as per Hypertension Canada's 2017 Guidelines;
* Have preserved instrumental activities of daily living (scoring \>6/8 on the Lawton-Brody Instrumental Activities of Daily Living \[IADL\] scale);
* Present signs of SCD (defined as answering yes to the question: "Do you feel like your memory or thinking skills have gotten worse recently?");
* Report being concerned about SCD (defined as answering yes to the question: "If yes, are you concerned about the worsening of your memory or thinking skills?");
* Preserved objective cognitive performance (i.e., no signs of MCI or dementia) defined by scoring ≥ 26 on the Montreal Cognitive Assessment (MoCA);
* Must be able to provide written informed consent.
Exclusion Criteria:
* Present signs of objective cognitive impairment (i.e., signs of MCI or dementia), defined by scoring ≤ 25 on the MoCA combined with study physician consult;
* Present resting stage 2 hypertension (seated, resting clinic SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
* Present significant neurological conditions or psychiatric disorders (e.g., Parkinson's disease or stroke \<1 year); 4) present history of severe cardiovascular conditions (e.g., recent \[\<1 year\] myocardial infarction, left ventricular hypertrophy) and symptomatic cerebrovascular disease;
* Present significant orthopaedic conditions (e.g., severe osteoarthritis in the lower limbs);
* Present untreated clinical depression (i.e., score \>15 on the Center for Epidemiologic Studies - Depression scale combined with study physician consult);
* Unable to comprehend the study letter of information. Participants will also be excluded for any other factors that could potentially limit their ability to fully participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT03545958
Study Brief:
Protocol Section:
NCT03545958