RISE UP: Rapid Intense Stair Exercise for Unleashing Metabolic Potential in Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 6-Hour Postprandial Glucose Area Under the Curve (AUC)
研究概览
简要总结
This study will examine whether very short bouts of stair climbing performed throughout the day can improve blood sugar control and cardiovascular health in adults with prediabetes. Participants will complete three separate study visits in random order: uninterrupted sitting, sitting interrupted by 3-minute light walking breaks each hour, and sitting interrupted by brief stair-climbing exercise "snacks" each hour.
During each visit, the research team will measure glucose, insulin, blood lipids, markers of inflammation and oxidative stress, and blood-vessel function. Continuous glucose monitors, blood samples, heart-rate and blood-pressure measurements, vascular ultrasound, and questionnaires will be used to assess the participants' responses.
The goal of the study is to determine whether brief stair-climbing breaks may be a practical way to reduce the negative effects of prolonged sitting and improve metabolic health in adults with prediabetes.
详细描述
This is a single-site, randomized, counterbalanced crossover pilot study evaluating the acute metabolic, vascular, and behavioral effects of interrupting prolonged sitting with brief stair-climbing exercise snacks in adults with prediabetes. A total of 20 participants will complete all three experimental conditions in randomized order, with a washout period of at least 7 days between visits.
The three experimental conditions are: (1) uninterrupted sitting, (2) sitting interrupted each hour by a 3-minute light walking break, and (3) sitting interrupted each hour by a brief stair-climbing exercise snack consisting of approximately 20 seconds of stair ascent at a fast but safe self-selected pace.
Participants will attend each experimental visit after an overnight fast. Two standardized meals will be provided during each approximately 6-hour experimental visit: Meal 1 at the beginning of the postprandial testing period and Meal 2 approximately 180 minutes later. Metabolic responses will be assessed using continuous glucose monitoring and serial blood sampling for glucose, insulin, lipids, inflammatory markers, and oxidative stress markers. Vascular responses will be assessed using noninvasive ultrasound. Heart rate, blood pressure, ratings of perceived exertion, symptoms, and participant-reported feasibility and acceptability will also be assessed.
The study is designed to determine whether brief hourly stair-climbing exercise snacks improve postprandial glucose and insulin responses and other cardiometabolic outcomes compared with uninterrupted sitting and light walking breaks, and to explore the feasibility and acceptability of this approach in adults with prediabetes.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Age 18 to 69 years, inclusive. Body mass index (BMI) 25.0 to 40.0 kg/m², inclusive.
- Objectively confirmed prediabetes based on at least one of the following:
- HbA1c 5.7% to 6.4%;
- fasting plasma glucose 100 to 125 mg/dL; or
- 2-hour plasma glucose 140 to 199 mg/dL during a 75-g oral glucose tolerance test.
- Able to understand study procedures and provide written informed consent in English.
- Able to safely perform repeated walking and vigorous stair-climbing activity based on medical history, resting vital signs, PAR-Q+ responses, investigator assessment, and medical clearance when required.
- Able to safely undergo repeated venous blood collection and IV-catheter placement.
- Able to safely consume the standardized study meals. Willing and able to complete all three experimental conditions and comply with fasting, dietary, physical-activity, medication, and pre-visit standardization instructions.
排除标准
- BMI below 25.0 kg/m² or above 40.0 kg/m². Diagnosed type 1 or type 2 diabetes mellitus. Laboratory findings that do not confirm prediabetes or that suggest diabetes, including HbA1c ≥6.5%, fasting plasma glucose ≥126 mg/dL, or 2-hour plasma glucose ≥200 mg/dL during a 75-g oral glucose tolerance test.
- Cardiovascular, pulmonary, musculoskeletal, neurological, or other medical conditions that would preclude safe participation in the walking or stair-climbing interventions.
- Resting vital signs, current symptoms, or other screening findings indicating that exercise participation would be unsafe.
- Pregnancy, plans to become pregnant during the study period, or breastfeeding. Current use of medications that may substantially affect glucose metabolism, lipid metabolism, body weight, study outcomes, or safe participation, including insulin, glucose-lowering medications, GLP-1 receptor agonists, pharmacologic weight-loss medications, systemic corticosteroids, or other medications judged by the investigator to interfere with study outcomes or safety.
- Contraindications to vascular ultrasound, repeated blood collection, IV-catheter placement, or exercise participation.
- Food allergies, intolerances, or dietary restrictions that prevent safe consumption of the standardized study meals.
- Known allergy or severe skin sensitivity to adhesives used with continuous glucose monitors.
- Bleeding disorder, current anticoagulant use, history of anemia, recent blood donation, recurrent fainting during blood collection, difficult venous access, or another condition judged to create unacceptable risk from repeated blood sampling or IV-catheter placement.
- Inability to safely perform repeated walking or stair climbing. PAR-Q+ result requiring further medical evaluation when the participant does not obtain required written medical clearance.
- Any other condition or finding that, in the judgment of the Principal Investigator or qualified study investigator, would make participation unsafe or substantially interfere with completion of study procedures.
研究组 & 干预措施
Uninterrupted Sitting
Participants will remain seated throughout the approximately 6-hour experimental visit, except as needed for study procedures. At the time points corresponding to activity bouts in the walking and stair-climbing conditions, participants will remain seated. This condition serves as the sedentary control condition.
Hourly 3-Minute Light Walking Breaks
Participants will interrupt prolonged sitting with a 3-minute light walking break at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. Walking breaks will therefore occur at 60-minute intervals.
干预措施: Hourly 3-Minute Light Walking Breaks (Behavioral)
Hourly Stair-Climbing Exercise Snacks
Participants will interrupt prolonged sitting with brief stair-climbing exercise snacks at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. During each bout, participants will ascend approximately three flights of stairs at a fast but safe self-selected pace for about 20 seconds.
干预措施: Hourly Stair-Climbing Exercise Snacks (Behavioral)
结局指标
主要结局
6-Hour Postprandial Glucose Area Under the Curve (AUC)
时间窗: From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
Plasma glucose will be measured from a fasting venous blood sample obtained before Meal 1 and from serial venous blood samples collected every 30 minutes through 360 minutes after Meal 1 completion. Meal 1 completion will define the start of the postprandial period, and a second standardized meal will be provided at approximately 180 minutes. Plasma glucose AUC will be calculated across the 6-hour experimental period and compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.
6-Hour Postprandial Plasma Insulin Area Under the Curve (AUC)
时间窗: From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
Plasma insulin will be measured from a fasting venous blood sample obtained before Meal 1 and from prespecified serial venous blood samples collected through 360 minutes after Meal 1 completion. Meal 1 completion will define time 0, and a second standardized meal will be provided at approximately 180 minutes. Insulin AUC will be calculated across the 0- to 360-minute experimental period and compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.
次要结局
- 6-Hour Postprandial Plasma Free Fatty Acid Response(From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion)
- 6-Hour Postprandial Plasma Triglyceride Response(From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion)
- Postprandial Plasma Malondialdehyde (MDA)(From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion)
- Postprandial Plasma Inflammatory Cytokines (TNF-α and IL-6)(From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion)
- Change in Superficial Femoral Artery Diameter(Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion)
- Change in Superficial Femoral Artery Blood-Flow Velocity(Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion)
- Change in Superficial Femoral Artery Shear Pattern(Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion)
- Heart Rate Response to Activity Bouts(Immediately before and immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion)
- Rating of Perceived Exertion During Activity Bouts(Immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion)
- End-of-Study Acceptability and Practicality Questionnaire Responses(After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment)
- Participant-Reported Barriers and Facilitators to Implementation(After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07847684
- 其他研究编号
- STUDY00000085, PROJ-000884
日期
- 首次提交
- (14天前)
- 首次发布
- (昨天)
- 主要完成日期
- (9个月后)
- 研究完成日期
- (9个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
De-identified individual participant data underlying the results reported in the primary publication may be shared upon reasonable request to the Principal Investigator, subject to institutional policies, applicable ethical and privacy requirements, and execution of an appropriate data-use agreement when required.