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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT06623669
Eligibility Criteria:
Inclusion Criteria:
* Aged 65+ years
* Body mass index of 30-45 kg/m2 or \>45 kg/m2 with physician's approval
* No loss or gain of more than 5% body mass in previous 6 months
* Presence of knee or hip osteoarthritis as ascertained via the Roux questionnaire
* Independently living
* Low active (i.e., not participating in regular resistance training and/or \>20 mins/day of aerobic exercise on more than 2 days/week in past 3 months as ascertained via a modified CHAMPS questionnaire)
* Have no contraindication for safe and optimal participation in exercise based on EASY screening
* Not currently using a weight loss medication
* Approved for participation by medical director
* Willing to provide informed consent and agree to all study procedures and assessments.
Exclusion Criteria:
* Reside in skilled nursing facility, rehab or assisted living environment
* History of pharmacologic treatment for a psychiatric disorder other than depression/anxiety within past year
* Current untreated and/or unstable clinical depression or anxiety (Patient Health Questionnaire (PHQ-9) \>15)
* Hospitalization for psychiatric event within past year prior to screening
* History of mild cognitive impairment or dementia
* Cognitive impairment (\<32) on Modified Telephone Interview for Cognitive Status survey (TICS-M)
* Hearing or visual impairment that would preclude use of the videoconferencing software
* Severe arthritis or other musculoskeletal disorder that is a contraindication for safe walking
* Presently undergoing treatment for orthopedic fracture
* Currently using a weight loss medication
* Contraindication based on EASY screening without physician approval.
* Joint replacement or other orthopedic surgery in past 6 months
* Joint replacement or other orthopedic surgery planned in next 18 months
* Have a diagnosis of uncontrolled hypertension; current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease; cancer requiring current treatment, except non-melanoma skin cancers; kidney failure requiring dialysis; have a Katz ADL disability; or engage in heavy alcohol use \>14 drinks/week.
* Current participation in other research study with a prospective intervention
* Unable/unwilling to commit to study protocol, including random assignment and use of technology tools
* Unable/unwilling to attend three virtual testing appointments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06623669
Study Brief:
Protocol Section:
NCT06623669