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 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07328334
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 80 years or older.
* Clinical diagnosis of frailty, defined by a Short Physical Performance Battery (SPPB) score \< 9.
* Ability to stand and walk with or without assistive devices.
* Ability to understand and follow instructions for inspiratory muscle training.
* Stable medical condition for at least 3 months prior to enrollment.
* Capacity to provide informed consent or availability of a legal
Exclusion Criteria:
* Acute or unstable cardiovascular, respiratory, or metabolic conditions.
* Severe cognitive impairment that prevents understanding the procedures.
* Diagnosis of neuromuscular diseases affecting respiratory muscles (e.g., ALS, myopathies).
* Severe or uncontrolled hypertension (≥180/110 mmHg).
* Recent thoracic or abdominal surgery (\<3 months).
* Severe musculoskeletal disorders limiting participation in training.
* History of recurrent syncope, severe dizziness, or intolerance to respiratory maneuvers.
* Any condition judged by the research team to compromise safety or participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
80 Years
Study:
NCT07328334
Study Brief:
Protocol Section:
NCT07328334