Examining the Effects of Live Telehealth Exercise Training on Cardiometabolic Outcomes in Wheelchair Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Cardiometabolic indicators - hsCRP
研究概览
简要总结
The study aims to test the benefits of a 24-week, cardio-emphasized Movement-to-Music exercise program for reversing cardiometabolic health risk factors compared to asynchronous, standard exercise programs among 132 adult wheelchair users. The targeted cardiometabolic health factors are waist circumference, triglycerides, "good" cholesterol, glucose, and blood pressure. Additionally, a 12-week follow-up phase (weeks 25-36) is included to see whether the gains are maintained.
详细描述
Baseline Assessment: Participants will be asked to complete a baseline assessment. This measures physical health (e.g., cardiometabolic health factors, fat/muscle mass) and functions (e.g., muscular strength, aerobic endurance) and a series of self-reported questionnaires that are related to participant's demographics, psychosocial health (depression, sleep, fatigue), quality of life, and physical activity behaviors (volume of activity). The onsite physical tests will take approximately 2 hours to complete. The questionnaires will be completed electronically and may take up to an hour. The assessments are listed below.
PHYSICAL TEST: The physical tests will take place (1) at the UAB Research Collaborative Center (3810 Ridgeway Dr. Birmingham, AL 35209) and (2) at Lakeshore Foundation's human performance lab (4000 Ridgeway Dr. Birmingham, AL 35209).
- Blood draw
- Anthropometrics (weight, height, waist circumference)
- Body composition (amount of fat mass and fat free mass) by dual x-ray absorptiometry (DXA): DXA scans will be performed to measure any changes in fat-mass and fat-free mass. X-ray scans will be performed on 3 occasions using an iDXA whole-body scanner (GE-Lunar Radiation Corporation, Madison, WI). The radiation dose is less than 1 mrem. Scans will be analyzed using CoreScan software, and muscle mass will be estimated using published equations. Trained lab staff will be available to assist with transitioning from the wheelchair to the scan platform and back again.
- Hand grip strength: Hand-held dynamometer will be used to measure any changes in grip strength.
- Aerobic endurance by an arm-crank ergometer and open-circuit spirometry system: Open-circuit spirometry system will be used to measure any changes in heart rate, rate of perceived exertion (i.e., how much effort you feel you are giving), and amount of air you can breathe out while performing a 20-minute, continuous arm-crank ergometer.
- Lung strength by spirometer: Spirometer will be used to measure how much air you exhale and how quickly you exhale. You will take a deep breath and breathe out as hard as you can for several seconds into the tube.
QUESTIONNAIRES:
- Leisure Time Physical Activity Questionnaire for Spinal Cord Injury
- NIH PROMIS Pain Intensity Short Form
- NIH PROMIS Pain Interference Short Form
- NIH PROMIS Fatigue Short Form
- NIH PROMIS Sleep Disturbance Short Form
- NIH PROMIS 10 Global Health Items
- NIH PROMIS Ability to Participate in Social Roles and Activities
- NIH PROMIS Depression Short Form
- NIH PROMIS Anxiety Short Form
- NIH PROMIS Physical Function Form
- Exercise Self-efficacy Scale
- Exercise Goal-setting and Planning Scale
- Demographics and Health History Questionnaire
- Rapid Eating Assessment for Participants Shortened Version
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a single-blinded study that conceals the group allocation from physical outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •full-time or part-time use of a wheelchair device (manual wheelchair, power wheelchair, electric scooter) self-reported as the primary means of mobility
- •≥ 2 cardiometabolic risk factor(s),
- •no contraindication to exercise as approved by a physician's medical clearance to exercise
- •age ≥18 years
- •able to use arms to exercise
- •obtaining < 90 minutes of moderate-intensity aerobic exercise per week in the last month
- •not enrolled in a structured exercise program in the past 6 months
- •able to converse and read in English.
排除标准
- •medically unstable to perform home exercise as determined by their physician
- •high-level tetraplegia and unable to use arms to exercise
- •no internet access was determined via self-report and internet speed test.
研究组 & 干预措施
Group 1
Instructor-led, one-on-one M2M exercise group
干预措施: Instructor-led, one-on-one M2M exercise group (Other)
Group 2
Self-guided control with pre-recorded standard exercise videos
干预措施: Self-guided control with pre-recorded standard exercise videos (Other)
结局指标
主要结局
Cardiometabolic indicators - hsCRP
时间窗: 24 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - HbA1C
时间窗: 24 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - fasting insulin
时间窗: 24 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - triglycerides
时间窗: 24 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - glucose
时间窗: 12 Weeks
Blood test Sphygmomanometer
Body composition - DEXA
时间窗: 24 Weeks
Dual energy X-ray absorptiometry
Cardiometabolic indicators - cholesterol
时间窗: 24 Weeks
Blood test Sphygmomanometer
Body composition - Waist Circumference
时间窗: 24 Weeks
Measurement of waist size
Body composition - Weight
时间窗: 24 weeks
participants weight
次要结局
- Physical health(36 Weeks)
- Cardiovascular capacity - Borg CR10 RPE Scale(24 Weeks)
- Muscle strength(24 Weeks)
- Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)(24 Weeks)
- Cardiovascular capacity - Polar heart rate monitor(24 Weeks)
- Pulmonary function(24 Weeks)
- Physical activity(36 Weeks)
研究者
Jereme Wilroy
Associate Professor
University of Alabama at Birmingham