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Not yet recruiting NCT07113444

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

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tai Chi, Moderate-Intensity Combined Exercise (MICE), Control ( No Exercise ).
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Tai Chi
    Yang style of Tai Chi (24 form)
  • Other 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
  • Other 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.

Primary outcome measures

  • Capillary blood glucose change from baseline [Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)]
Secondary outcome measures (7)
  • Carotid-femoral pulse wave velocity (PWVcf) change from baseline [Time frame: 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 [Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)]
  • Central blood pressures change from baseline [Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)]
  • Heart rate variability (HRV) change from baseline [Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)]
  • Brachial blood pressure (BP) change from baseline [Time frame: 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 [Time frame: 24 hours]
  • 24-hour heart rate variability (HRV) difference between interventions [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

only with type 2 diabetes

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07113444 · CAAE: 88582225.1.0000.5398

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗