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临床试验/NCT07113444
NCT07113444尚未招募不适用

The Acute Effect of Tai Chi Versus Moderate-Intensity Combined Exercise on Cardiovascular, Metabolic, and Cardiac Autonomic Control Parameters in Older Men and Women With Type 2 Diabetes Mellitus: A Randomized, Single-Blind, Crossover Controlled Trial

Universidade Estadual Paulista Júlio de Mesquita Filho0 个研究点目标入组 24 人开始时间: 2025年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
主要终点
Capillary blood glucose change from baseline

研究概览

简要总结

Type 2 diabetes mellitus (T2DM) in the elderly population is associated with compromised cardiovascular and metabolic functions, thereby necessitating the implementation of safe exercise interventions. This study employs a randomized, single-blind, crossover design will be conducted in Brazil to examine whether Tai Chi, a low-impact mind-body exercise, offers acute benefits comparable to those of moderate-intensity combined exercise (MICE) in 24 older adults (≥65 years) diagnosed with T2DM, consisting of 12 men and 12 women. Participants recruited through community advertisements and screened to ensure inactivity, stable medication usage, and the absence of significant comorbidities will undergo randomized sessions of Tai Chi, MICE, and a control (CON) intervention. Evaluations will include capillary blood glucose (the primary outcome), blood pressure, heart rate variability, arterial stiffness (PWVcf), and endothelial function (FMD) measured before, immediately after, and 45minute post-intervention, along with 24-hour ambulatory monitoring. Standardized protocols will be employed to regulate physical activity. By juxtaposing these interventions, the study seeks to ascertain if Tai Chi could serve as a feasible alternative for enhancing acute metabolic and cardiovascular responses in older diabetic adults, thus providing practical insights for clinical and lifestyle management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •only with type 2 diabetes

排除标准

  • •if not able to perform physical exercise (Extreme neuropathy, wounds in the feet, and amputation risk.)

研究组 & 干预措施

Tai Chi

Experimental

40-60 minute supervised Yang-style Tai Chi lesson (24-form simplified pattern). Focus on calm, controlled movements and breathing coordination.

干预措施: Tai Chi (Other)

Moderate-Intensity Exercise (MICE)

Experimental

The MICE session will consist of five minutes of warm-up (joint mobility and stretching exercises between PSE levels 9 and 11, 30 minutes of walking on the treadmill between PSE levels 12 and 13, 20 minutes of muscle strengthening exercises between levels 12 and 14 of PSE (two sets of 15 to 20 repetitions in circuit in the exercises bent row with elastic band, bodyweight squats, adapted push-ups (on the wall or on the counter), deadlifts with an elastic band, presses with an elastic band and an abdominal band on the floor or adapted on the chair) and five minutes of back to calm (light stretching and breathing exercises at PSE level 9).

干预措施: Moderate-Intensity Combined Exercise (MICE) (Other)

Control (No Exercise)

Sham Comparator

The CON session will consist of 60 minutes of rest in the sitting position. Participants will be told not to sleep and will not have access to reading or electronic devices during the CON session.

干预措施: Control ( No Exercise ) (Other)

结局指标

主要结局

Capillary blood glucose change from baseline

时间窗: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)

Capillary blood glucose will be measured using a digital glucometer (FreeStyle Optium Neo, 163 Abbott, Oxon, UK) in milligrams per deciliter (mg/dL)

次要结局

  • Carotid-femoral pulse wave velocity (PWVcf) change from baseline(Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105))
  • Brachial artery flow-mediated dilation (FMD) change from baseline(Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105))
  • Central blood pressures change from baseline(Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105))
  • Heart rate variability (HRV) change from baseline(Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105))
  • Brachial blood pressure (BP) change from baseline(Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105))
  • 24-hour ambulatory blood pressure monitoring (ABPM) difference between interventions(24 hours)
  • 24-hour heart rate variability (HRV) difference between interventions(24 hours)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emmanuel Gomes Ciolac

Full Professor of Department of Physical Education

Universidade Estadual Paulista Júlio de Mesquita Filho

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