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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03440320
Eligibility Criteria:
Inclusion Criteria:
Both members of the caregiving dyad:
* Chronic musculoskeletal pain, present for a minimum of three months
* Moderate or high levels of daily pain-related disability (BPI ≥ 5)
* Part of caregiving dyad
* Adults age 18 and over and able to speak English
* Score \>4 out of 6 on the short Mini Mental Status Exam
* Ability to stand with or without an assistive device
* Sedentary lifestyle (i.e., any waking behavior characterized by an energy expenditure ≤1.5 metabolic equivalents while in a sitting or reclining posture)
Inclusion for care recipient only:
-Living at home in the community (with or without caregiver)
Inclusion for caregiver only:
* Identified as the primary caregiver
* Caregiver at least the past six months
Exclusion Criteria:
* Significant cardiovascular disease: New York Heart Association functional class 3 or 4 congestive heart failure; systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 105 mmHg; myocardial infarction within 3 months, chest pain or dizziness with exercise
* Stroke, or Transient Ischemic Attack within 6 months
* Respiratory conditions requiring use of oxygen at home (i.e., COPD)
* Receiving or planning to receive, cancer treatment in the next 6 months
* Alzheimer's disease, dementia; expectation of death in the next 12 months
* In current physical rehabilitation, drug/alcohol treatment, or exercise research study
* Completed self-management education in the last year
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03440320
Study Brief:
Protocol Section:
NCT03440320