Heart Rate Variability-Guided Exercise Training in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Peak aerobic capacity (fitness)
研究概览
简要总结
The primary aim of this randomized clinical trial is to determine the effectiveness of a 16 wk individualized aerobic exercise program, using heart rate variability to guide the exercise prescription, for increasing aerobic capacity of individuals with type 2 diabetes, compared to a traditional exercise training paradigm and usual care. To accomplish this aim the investigators plan to test for greater improvements in: 1) fitness (primary outcome); as well as secondary variables of 2) cardiovascular autonomic function via baroreflex function; 3) glucose control (HbA1c); and 4) psychosocial factors.
详细描述
This study will examine participant's fitness levels before and after a 16 week intervention period. There are two study visits prior to starting the intervention period. During Baseline Study Visit #1, the investigators will take a health history, determine the height and weight of the participants, and have participants complete a physical activity questionnaire and a 3-day diet log, as well as determine muscle and fat mass, followed by tests that examine how blood vessels function, and lastly a treadmill test to determine aerobic fitness. During Baseline Study Visit #2, which takes place 5-7 days later, the investigators will measure blood pressure, heart rate, and glucose control through a glucose challenge test. The glucose challenge tests requires taking ~3 Tablespoons of blood to be assessed for glucose, insulin and hemoglobin A1c. Lastly, participants will complete 3 questionnaires regarding quality of life, fatigue, and depression.
After completion of the two pre-training data collection visits, participants will be randomized to 1 of 3 groups: 1) HRV-guided exercise group (HRV); 2) traditional exercise training group (TRAD); or 3) usual care group. There will be approximately 30 subjects in each group, providing an equal chance of being assigned to either group. Both the HRV and TRAD groups will participate in a combined lab-supervised and home-based exercise program (with 1 day1 per week supervised in the laboratory and 3 days per week at home) over the course of 16 weeks. Furthermore, both exercise groups will participate in online/phone counseling in order to provide support. Specifically, participants will be provided with a phone number to the lab to call study personnel for assistance if needed. Weekly internet video chats through Zoom or phone calls, if Zoom is unavailable, will be conducted by a trained exercise-behavior change coach to help participants focus on self-efficacy, outcome expectations, impediments (barriers), and goal setting.
Post-training testing Visits #3 and #4 Visits #3 and #4 will be identical to visits #1 and 2, with the exception that the demographic questionnaire will not be administered again. This will mean there is a total of 100 mL of blood taken over the course of the entire study, between Visits 2 and 4 combined, which will total ~6 total Tablespoons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index range = 30.0 to 40.0 kg/m2
- •Being sedentary (<1 h regular physical activity/wk)
- •Medication stable for 3 mo.
- •Current use of physician confirmed diabetes medication, fasting glucose values ≥ 126 mg/dL and 2 hr oral glucose tolerance test (OGTT) values ≥ 200 mg/dL will be used as the criteria for type 2 diabetes
排除标准
- •Type 1 diabetes, [insulin use]
- •Major depressive disorder
- •Severe neuropathy
- •Current tobacco use (must have quit for 1 yr or more if a previous user)
- •Renal, liver, peripheral artery, or carotid artery disease
- •Current cancer (must be at least 6 mo cancer-free)
- •Beta-blockers
- •Perimenopausal women, post-menopausal women experiencing hot flushes and not on hormone therapy
- •Alcohol consumption greater than 7 drinks/wk
- •Acute coronary syndrome within the last 6 mo, heart failure, pacemaker, and any additional contraindications to participation in exercise testing or an exercise training program.
结局指标
主要结局
Peak aerobic capacity (fitness)
时间窗: 4 months
Aerobic capacity (e.g. fitness) will be measured during a treadmill test that assess how much oxygen the muscles need during exercise. Aerobic capacity (VO2peak) will be reported as mL/min/kg.
次要结局
- Glucose control(4 months)
- Baroreflex sensitivity(4 months)
- Fatigue severity scale(4 months)
- Depression questionnaire(4 months)
- Quality of life questionnaire(4 months)
研究者
Erin Vidra
Associate Professor
University of Illinois at Chicago