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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Tai Chi
  Yang style of Tai Chi (24 form)
• Другое Moderate-Intensity Combined Exercise (MICE)
  start from warm up (5 minute )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 cool down in the end
• Другое Control ( No Exercise )
  The CON session will last 60 minutes and will be conducted only sitting. Participants will be told not to sleep and will not be allowed to use reading materials or any electrical gadgets during the CON session.

Первичные конечные точки

• Capillary blood glucose change from baseline [Срок оценки: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)]

Вторичные конечные точки (7)

• Carotid-femoral pulse wave velocity (PWVcf) change from baseline [Срок оценки: 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 [Срок оценки: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)]
• Central blood pressures change from baseline [Срок оценки: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)]
• Heart rate variability (HRV) change from baseline [Срок оценки: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)]
• Brachial blood pressure (BP) change from baseline [Срок оценки: 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 [Срок оценки: 24 hours]
• 24-hour heart rate variability (HRV) difference between interventions [Срок оценки: 24 hours]

Критерии участия

Критерии включения

only with type 2 diabetes

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07113444 · CAAE: 88582225.1.0000.5398

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗