治験レーダー

Procedures:

Study Phase I: Families (n=60) will complete a baseline research visit. Youth will then be randomized to one of the exercise groups and complete one instructional exercise session, in person, at the UMMC Center for Integrative Health (CIH). After the instructional exercise session youth will complete a 3-day home ambulatory monitoring protocol. Study Phase II: Youth will then complete an 8-week Telehealth home exercise protocol. Youth will complete a 3-day ambulatory monitoring protocol during weeks 4 and 8. Youth will return to the UMMC CIH within one week of completing the exercise protocol to repeat questionnaires and clinical assessment. Parents will also repeat questionnaires.

Study Phase I:

Baseline Research Visit: Once enrolled, the RA will obtain parent contact information and contact information for two other relations. Youth and their parent will complete questionnaires using REDCap electronic data collection on Apple iPads (10 minutes). Questionnaires will include items on demographics, pain, physical functioning, and negative emotions (due to depression and negative affect being among the most robust predictors of pain in youth with SCD11,63,112,113). Blood draw: A blood sample will be collected (10 minutes) for the purpose of measuring baseline inflammatory markers. Every effort will be made to collect blood during scheduled clinical blood draws and using topical lidocaine cream. Clinical and Physical fitness assessment: Next, an Actigraph GT9X-BT device will be placed on youth's wrist to monitor HRV for the duration of the baseline research visit. Youth will then complete clinical and physical fitness assessments (30 minutes; detailed below).

Exercise Intervention: Randomization. Sixty numbers will be randomly assigned to either the low systemic strength training or the moderate systemic exercise groups in a 2:1 manner using the Microsoft Excel 2013 RANDBETWEEN1,2 function. Randomization order will be password protected and unlocked just prior to the instructional exercise session. However, of note, if families indicate that they do not have a safe environment to complete the moderate systemic exercise intervention (i.e., do not have a safe place to walk outside), then the youth participant will be assigned to the low systemic strength training group. The next eligible participant will be assigned to the moderate systemic exercise group to fulfill that randomization. Instructional Exercise Session. Youth will perform one 45-minute exercise session in-person at the UMMC CIH center. Prior to beginning exercise, exercise personnel will educate youth and parents regarding safe exercise (e.g., staying hydrated, moderate exercise levels) and potential adverse events75 (e.g., fatigue, muscle soreness; see Protections against risks, Exercise Sessions for more detail). At 5 minutes before exercise; 10, 20, 30, and 40 minutes during exercise, and 5 minutes after exercise pain intensity (primary outcome) and HRV (secondary outcome) will be obtained. 3-day Ambulatory Monitoring. Following the instructional exercise session, youth will partake in 3 consecutive days of actigraphy ambulatory monitoring and complete three days of pain diary. An actigraph is worn like a watch on the wrist of your non-dominant hand and measures physical activity, sleep, and heart-rate through light and movement and heartrate variability through a heart rate monitor. Daily diary pain intensity and actigraphy-derived HRV at 24-hours will be collected and contribute toward Aim 1: Hypotheses 1a and 1b. To reduce participant burden, wrist-worn Actigraphy devices will be returned via standard mail in a padded envelope.10

Study Phase II:

8-Week Telehealth Exercise Protocol. Using a within- and between-subject design, youth will serve as their own control (pre-post) and will complete 8-weeks (3 times per week; 45-minute sessions) of either (1) low systemic strength training or (2) moderate systemic exercise training. After the instructional exercise session, all exercise sessions will be completed at the home and supervised by study exercise personnel via Telehealth. A parent must also be present in the home during each exercise session. If a parent is not present, the exercise session will be rescheduled. Exercise personnel will record exercise adverse events at each session. All adverse events will be immediately reported to the medical director and PI.

3-day Ambulatory Monitoring. During week 4 and week 8 of the Telehealth exercise protocol, youth will partake in 3 consecutive days of daily diary and actigraphy ambulatory monitoring. Wrist-worn actigraphy devices will be returned via standard mail in a padded envelope and/or at the follow-up visit.

Follow-Up Visit. Families will return to the UMMC CIH within 1 week of completing the 8-week Telehealth exercise protocol. Youth will repeat questionnaires on pain (primary outcome, Aim 2) and assessment of HRV and physical fitness (secondary outcomes, Aim 2). Parents will also repeat questionnaires.