Cadence and Intensity in Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Oxygen consumption (VO2; mL/kg/min)
研究概览
简要总结
The purpose of this study is to measure and link cadence (number of steps taken in a minute) to intensity of physical activity (e.g., low-intensity, moderate intensity, vigorous-intensity) in adults (40- 65 years-old) with type 2 diabetes.
详细描述
There will be up to two lab visits for participants, all of which will be completed in the Physical Activity and Health Lab at University of Massachusetts Amherst (consent, physical examination and entire research protocol, 2.5-3.5 hrs for all participants).
The first visit will consist of an orientation session. This orientation will begin with screening questions to determine eligibility and obtaining informed consent (45 min), followed by a physical exam and resting ECG for all participants (30 min):
Screening Questions: Participants will self-report their diagnosis of type 2 diabetes and year of diagnosis. Medication used for controlling diabetes will be determined by participants bringing their medication bottle or a photo of its label. Participants will answer additional questions (documentation attached) in an interview-style format with research staff to determine eligibility (15 min). These questions will be derived from the American Heart Association's (AHA) risk stratification found in the 2013 edition of the American College of Sports Medicine's (ACSM's) Resource for The Health Fitness Specialist. According to this screening, all participants with type 2 diabetes are considered high risk but the additional cardiac, pulmonary, and metabolic disease-related questions will be used for descriptive purposes. Given the low impact of this protocol, the volunteer's personal physician does not need to provide clearance. The PI, who is a physician, will be available to review individual circumstances prior to testing.
Informed Consent: Research staff will present an orientation slideshow to participants regarding the study purpose, study procedures, and rights as a participant (slideshow attached). Participants will then review and sign informed consent documents. (30 min)
Physical Exam: A physical exam will be conducted by study staff under the guidance of the medical director (Stuart Chipkin, MD) to assess for medical conditions that may interfere with the exercise protocol and ensure participant safety. In addition, the medical director will conduct tests for diabetic neuropathy with the neuropathy symptom and change (NSC) score, neuropathy impairment score (NIS). The NSC consists of a series of questions about neuropathy-related pain and numbness, maneuvers that relieve symptoms, and arousal from sleep. The NIS is a battery of tests that assess the ankle reflex as well as vibration, pin-prick, and temperature sensation in the great toes. (15 min)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to ambulate on a treadmill (self-reported)
- •Diagnosed with type 2 diabetes (self-reported)
- •Self-report participating in less than 30 minutes of moderate intensity exercise per day for most days of the week
- •Able to fast for at least 4 hours prior to study visit involving the treadmill protocol
- •Self-report having an HbA1c measure greater than 7% in the past 6 months
排除标准
- •BMI - <18.5kg/m² or >40kg/m²
- •Tobacco use - Currently a smoker or have smoked tobacco within the past 6 months.
- •Insulin - Those with type 2 diabetes being controlled with insulin
- •Ambulatory ability - Since the focus herein is on ambulatory activities, participants who use wheelchairs or other impairments that prevent normal ambulation will be excluded. This criterion is similar to that used by NHANES when selecting individuals (up to 85 years of age) to wear motion sensors.
- •Resting Blood Pressure - Systolic blood pressure greater than 159 mmHg or diastolic blood pressure greater than 99mmHg
- •Abnormal resting ECG (evaluated by physician) will be advised to see personal physician (participant provided with resting ECG results)
- •Any condition/medication that may affect heart rate response to exercise testing.
- •Current participation in any other study protocol which involves taking an experimental medication
- •Hospitalization for mental illness within the past 5 years.
- •Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks (TIAs), chest pain, unusual dyspnea during physical activity/ exercise, severe ankle edema, or intermittent claudication.
- •Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.
- •Participant experiences dizziness or balance impairment at rest or with exercise
- •Participant is currently treated for kidney disease with dialysis, or has severe liver damage? (e.g., liver cirrhosis)
- •Participant has a pacemaker or other implanted medical device (including metal joint replacements).
- •Participant has chronic lung problems that make it difficult to breathe (e.g., Chronic Respiratory Diseases, Cystic Fibrosis, chronic obstructive pulmonary disease [COPD] or uses supplemental O2)
- •Participant has Cancer treated with chemotherapy that affects breathing or heart rate
- •Participant experiences shortness or breath at rest or during mild exertion
- •Participant is pregnant.
- •Participant is unable to complete all testing within a maximal two-week period
- •Individuals wearing a full beard may need to be excluded from the study, as large amounts of facial hair around the mouth and nose interfere with the seal of the device that measures the air being breathed. Because of this we are seeking participants that are clean shaven or with a beard where areas around the nose and mouth are clean shaven (e.g. goatee).
- •Any significant medical condition that may interfere with the study.
结局指标
主要结局
Oxygen consumption (VO2; mL/kg/min)
时间窗: Through completion of the treadmill walking protocol that occurs during the study visit (approximately 1 hour)
The amount of oxygen consumed, as measured with indirect calorimetry, expressed per unit of body mass
Cadence (steps/min)
时间窗: Through completion of the treadmill walking protocol that occurs during the study visit (approximately 1 hour)
Cadence (steps/min) as assessed by direct observation of steps (hand-tallied counts) divided by time
次要结局
未报告次要终点
研究者
Stuart R Chipkin
Research Professor
University of Massachusetts, Amherst