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 @ 12:40 PM
Ignite Modification Date:
2025-12-24 @ 12:40 PM
NCT ID:
NCT07178561
Eligibility Criteria:
Inclusion Criteria:
1. Age: 60 years or older.
2. Chronic Low Back Pain: History of low back pain lasting ≥12 weeks Poor sleep quality, defined as a Pittsburgh Sleep Quality Index (PSQI) score \>5.
3. Mild to moderate symptoms of anxiety or depression, defined as a Hospital Anxiety and Depression Scale (HADS) score \>7.
4. Ability to walk independently or with minimal assistance, allowing participation in treadmill or cycling exercises.
Exclusion Criteria:
1. Severe Mental Health Issues: Severe anxiety or depression (HADS score \>15) or any other major psychiatric disorder.
2. Acute or Unstable Medical Conditions: Including recent cardiovascular events (e.g., myocardial infarction, unstable angina), uncontrolled hypertension, or severe respiratory disease.
3. Severe Musculoskeletal Disorders: Conditions that prevent safe participation in exercise, such as recent fractures, severe osteoporosis with risk of fracture, or advanced spinal pathology.
4. Neurological Disorders: Significant neurological impairments affecting balance or mobility (e.g., stroke, Parkinson's disease, severe peripheral neuropathy).
5. Recent Spine Surgery: Lumbar or spinal surgery within the past 6 months.
6. Cognitive Impairment: Inability to understand instructions or provide informed consent.
7. Participation in structured exercise programs in the past 3 months that could confound results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT07178561
Study Brief:
Protocol Section:
NCT07178561