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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT02225028
Eligibility Criteria:
Inclusion Criteria:
* English as primary language.
* History of traumatic SCI (C6 or below/ ASIA A-D) and uses a manual wheelchair at least 50% of the time.
* Injured at least one year prior to enrollment.
* Reports less than 150 minutes per week of moderate to vigorous physical activity.
* Presence of two or more cardiometabolic risk factors:
1. Body Mass Index (BMI) greater than 21.
2. Fasting high density lipoprotein cholesterol (HDL) greater than or equal to 40 mg/dL.
3. Fasting triglycerides less than or equal to 150 mg/dL.
4. Fasting glucose greater than or equal to 100 mg/dL.
5. Blood pressure of 120-139 (systolic) / 80-89 (diastolic).
* Physician approval to initiate physical activity program.
Exclusion Criteria:
* Body Mass Index (BMI) greater than 40.
* Medically diagnosed ischemic heart disease; unstable angina, dysrhythmia or unstable autonomic dysreflexia; recent osteoporotic fracture, tracheostomy.
* Medically diagnosed hyperlipidemia: on lipid lowering medication or detected during baseline lipid panel.
* Medically diagnosed hypertension: on antihypertensive medication or hyertension detected during secondary screening/baseline exam.
* Engaged in a structured exercise program within 6 month of enrollment.
* Engaged in a structured diet program.
* Presence of conditions that would preclude participation in home-physical activity program such as: pressure ulcer, current substance dependence, psychosis, severe chronic upper extremity pain, surgery pending within 6 months, current infection or illness requiring hospitalization, or participation in another research study.
* Electrocardiographic abnormalities detected during any exercise test: 2o or 3o AV block, pre-excitation arrhythmia, hemi-blocks, S-T segment depression (horizontal, down sloping, or up sloping) diagnostic of myocardial ischemia, or other restrictions (ACSM Guidelines 7th Edition).
* Current use of the following medications: Lipid lowering agents (e.g., statins, fibric acid derivatives, niacins, bile-acid sequestrates, or cholesterol uptake blockers), antihyperglycemics (biguanides, sulfonyureas, incretins, TZDs), herbal medicines and hyper-vitamins having antilipemic or antihyperglycemic properties, antihypertensives (Carbonic Anhydrase Inhibitors, thiazides, or loop diuretics), and estrogen replacement therapy.
* Anticipated reasons subjects may be discharged from the trial and/or referred for medical therapy (if indicated): At the 6 month assessment subject laboratory values indicate they require medical treatment for diabetes, hyperlipidemia or hypertension; pregnancy; pressure ulcer that affects the safety of performing physical activity. NCEP ATP Guidelines will serve as the criterion for need for lipid intervention, ADA guidelines for diabetes, and JNC VII Guidelines for Hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02225028
Study Brief:
Protocol Section:
NCT02225028