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 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT07017504
Eligibility Criteria:
Inclusion Criteria:
1. Patients with age-related diseases affecting balance and joint sense, who meet two or more of the following criteria for sarcopenia:
* Muscle strength: Handgrip strength \< 28 kg (men), \< 18 kg (women)
* Physical performance: Short Physical Performance Battery (SPPB) ≤ 8 points
* Muscle mass: Bioimpedance analysis showing \< 7.0 kg/m² (men), \< 5.7 kg/m² (women)
2. Able to fully understand and follow instructions related to walking, sitting, and balance.
Exclusion Criteria:
1. Unable or unwilling to provide informed consent
2. High risk of falls due to severe visual impairment or dizziness
3. Communication difficulties due to speech, language, or hearing problems
4. Inability to walk independently without assistive devices
5. History of diseases affecting gait, efficiency, or endurance, such as:
* Neurological disorders (e.g., stroke, Parkinson's disease)
* Musculoskeletal disorders affecting the lower limbs
* History of major orthopedic surgery on the lower limbs
* Severe back pain or musculoskeletal pain affecting gait
* Cardiovascular disease including heart failure or uncontrolled hypertension
* Pulmonary diseases requiring regular oxygen therapy
* Cancer requiring treatment within the past 3 years (except for non-melanoma skin cancer or early-stage breast/prostate cancer)
* Psychiatric disorders such as schizophrenia, other psychoses, or bipolar disorder
* Any other disease that significantly limits mobility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07017504
Study Brief:
Protocol Section:
NCT07017504