Low Systemic/High Local Exercise Load in Pediatric Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pediatric Pain Questionnaire
研究概览
简要总结
This research study wants to learn about what kind of exercise is best for kids with sickle cell disease. Participating children will have a small amount of blood drawn one time at the beginning of the study. Children will then complete some questionnaires that measure pain, physical function, and emotions (depression, anxiety) and complete some tests that measure physical fitness at the beginning and end of the study. Children will be randomized to either a home-based telehealth (1) walking or (2) strengthening exercise program that lasts for 8-weeks, 3-x week, for 45 minutes each session. Children's participation will last up to 10 weeks.
详细描述
Overview: The current pilot study is a randomized behavioral exercise intervention.
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •youth 12 to 17 years old
- •diagnosed with SCD genotype SS, SC, beta-plus thalassemia, or beta-zero thalassemia
- •has daily access to an Internet enabled device (e.g., smart phone, IPad) A parent (≥21 years old) will also be recruited for each youth participant.
排除标准
- •non-English speaking due to lack of available written translation services for informed consent and questionnaires
- •cognitive impairment (e.g., moderate to profound intellectual disability) that precludes study completion
- •medical condition (e.g., hypertension, bone fracture) that precludes completing exercise safely (determined by study medical director Dr. McNaull).
结局指标
主要结局
Pediatric Pain Questionnaire
时间窗: through study completion, an avg. of 10 weeks
The Pediatric Pain Questionnaire (PPQ, youth and parent version) is well-validated and consists of two 100 mm visual analogue scale items that measure present pain intensity and worst pain in the past week. One question of pain frequency will be added (0 = not at all to 6 = daily pain). The present pain intensity item will measure pain intensity during exercise sessions.
NIH PROMIS 2582
时间窗: through study completion, an avg. of 10 weeks
The NIH PROMIS 2582 (youth and parent-proxy) includes 25-items on physical function mobility, anxiety, depression, fatigue, peer relations, pain interference, and pain intensity. Items are scored on a 5-point Likert scale and converted to standard T-scores; except pain intensity (10-point numeric rating scale).
Blood Pressure
时间窗: through study completion, an avg. of 10 weeks
Vital Signs measured will include blood pressure (BP). Systolic and diastolic blood pressure will be measured following a 5-minute rest period, three times (1 minute apart) in the non-dominant arm using automated oscillometric measurement and an appropriate-sized cuff.
Bruininks-Oseretsky Test of Motor Proficiency
时间窗: through study completion, an avg. of 10 weeks
Physical fitness will be assessed using the well-validated Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (4-21 years) to measure upper-limb and bilateral coordination, balance, running speed and agility, and strength.86,87 Aerobic endurance will be measured using American Thoracic Society 6-minute walk test guidelines. Dr. Daniels will train exercise personnel and the study RA in clinical assessment to proficiency and review 30% of data for research fidelity.
Biomarkers
时间窗: pre- 2 weeks
Utilizing the UMMC Immunology Biomarker Core under senior mentor Dr. Marshall, we will measure inflammatory IL-6, TNF-α, and CRP biomarker18-21 levels. 10 mL whole blood samples will be collected in heparinized tubes.96-98 Plasma samples will be rapidly obtained by centrifugation and will be stored at -80◦C in a research freezer until batch analyzed. Inflammatory marker IL-6 and TNF-α concentrations will be analyzed using Luminex® assay kits. We will examine CRP and using antibody-sandwich ELISA (Assaypro LLC, St. Charles, MO). Standard laboratory and assay measurement limits, normal and cut-off age values will be used to define absolute and high values.
Demographics and medical history (parents)
时间窗: through study completion, an avg. of 10 weeks
Parent name, address, email, social media contact information, child age, gender, diagnosis, prescribed medication dose and frequency, grade in school, parent marital status, parent education, and family income.
American Thoracic Society 6-minute walk test
时间窗: through study completion, an avg. of 10 weeks
Aerobic endurance will be measured using American Thoracic Society 6-minute walk test guidelines. Dr. Daniels will train exercise personnel and the study RA in clinical assessment to proficiency and review 30% of data for research fidelity.
Heart Rate Variability
时间窗: through study completion, an avg. of 10 weeks
HRV for both Phase I and II will be recorded using the Actigraph GT9X-BT device capable of collecting R-R intervals, and in accordance with established guidelines.22 Time Domain measures will include the standard deviation of normal RR intervals (SDNN, reflects sympathetic activity), and the square root of the mean squared differences between normal adjacent R-R intervals (RMSSD, reflects parasympathetic activity). Spectral analysis of HRV will be derived via a 1024-point linear fast Fourier transformation using a Hamming window. The resultant power density spectrum will be analyzed for total power (0.00-0.40 Hz), LF (0.04-0.15 Hz), and HF (0.15-0.40 Hz). LF and HF will be further normalized (LFNU and HFNU) to quantify sympathovagal balance.
Actigraphy
时间窗: through study completion, an avg. of 10 weeks
Objective recordings of daily HRV will be assessed with an Actigraph GT9X-BT device and computed using the ActiLife 6 software package. The watch-like device is worn on the non-dominant wrist.92 Wrist actigraphy has been validated in both healthy children and children with chronic pain.92-95
Medical Chart Review
时间窗: pre- 2 weeks
The following variables will be extracted from youth's electronic health record: date of birth, diagnoses, prescribed medications, complications, blood laboratory results over the past year, height and weight at last clinic visits, and number of emergency room visits and hospitalizations for pain during past three years. Complications and pain-related visits/hospitalizations will determine SCD disease severity. A potential concern in this study is the broad age range of 12-17 year olds, with children's changing immune system and differences in pubertal Tanner stage potentially impacting their physiological response to exercise. Thus, age and estimated pubertal Tanner stage will be examined as possible covariates. Pubertal status according to Tanner Stage criteria will be estimated by the pediatric hematologist/nurse practitioner at a regular office visit. All practitioners have appropriate training in pediatric examination.
Functional Disability Inventory
时间窗: through study completion, an avg. of 10 weeks
The Functional Disability Inventory (FDI, youth and parent version)79 is a 15-item well-validated scale assessing difficulty in physical and psychosocial functioning due to physical health (0 = no trouble to 4 = impossible).80,81
Heart Rate
时间窗: through study completion, an avg. of 10 weeks
Vital Signs measured will include heart rate (Phillips Healthcare; Netherlands).
Daily diaries
时间窗: through study completion, an avg. of 10 weeks
Diary items are derived from the above questionnaires, created in REDCap, take less than 3 minutes to answer, and will be completed once in the evening at a specified time. A diary link will be texted or emailed to the participant's smartphone or computer. Diary items will include: pain duration (pain start and stop time), pain intensity (100 mm visual analogue scale), daily mood (e.g., worried, sad), pain medications, and functional disability. All diary information will be immediately encrypted in REDCap.
次要结局
未报告次要终点