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NCT Number: 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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Tai Chi

Other

Yang style of Tai Chi (24 form)

Other names: Tai ji, Tai Chi Chuan

Moderate-Intensity Combined Exercise (MICE)

Other

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

Control ( No Exercise )

Other

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 outcomes

  1. 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)

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

Secondary outcomes

  1. 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)

    Carotid-femoral pulse wave velocity (PWVcf) will be measured using an automated device (Complior Analyze™ PWV and Central Pressure Analysis™; AlamMedical, Saint-Quentin-Fallavier, France), in meters per second (m/s)

  2. 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)

    Brachial artery flow-mediated dilation (FMD) will be measured using an ultrasound device (SonoSite M-Turbo™; Fujifilm Inc., Bothell, Washington, USA), and will consist in the brachial artery diameter difference between before (baseline diameter) and after (peak diameter) the artery occlusion for 5 minutes. FMD will be expressed in percentage (%) and will be determined by the following formula: FMD (%) = (peak diameter - baseline diameter)/baseline diameter × 100

  3. 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)

    Central blood pressures will be assessed directly from the carotid pressure waveform, in millimeters of mercury (mmHg), and using a non-invasive automated device (Complior Analyze™ PWV and Central Pressure Analysis™; AlamMedical, Saint-Quentin-Fallavier, France)

  4. 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)

    Heart rate variability will be assesseded using a digital telemetry system (Polar H10™, Polar Electro Inc, Kempele, Finland) to measure HR signals beat-to-beat. A sequence of 256 stable R-R intervals will be used to calculate frequency and time domain indexes, in hertz (Hz) and milliseconds (ms), respectively

  5. 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)

    Systolic and diastolic brachial blood pressure (BP) will be measured using an automatic monitor (Omron HEM 7200™, Omron Healthcare Inc., Dalian, China) in millimeters of mercury (mmHg)

  6. 24-hour ambulatory blood pressure monitoring (ABPM) difference between interventions

    Time frame: 24 hours

    Ambulatory systolic and diastolic blood pressure monitoring (ABPM), in millimeters of mercury (mmHg), will be measured for 24 hours after the end of each visit (approximately 90 minutes after the end of the Tai Chi, moderate-intensity combined exercise and control interventions), after a brief bath and using an automatic equipment (CardioMapa™, Cardios Sistemas Comercial e Industrial Ltda., São Paulo, Brazil).

  7. 24-hour heart rate variability (HRV) difference between interventions

    Time frame: 24 hours

    Ambulatory heart rate variability (HRV) will be assessed for 24 hours after the end of each visit (approximately 90 minutes after the end of the Tai Chi, moderate-intensity combined exercise and control interventions), after a brief bath and using an automatic equipment (CardioMapa™, Cardios Sistemas Comercial e Industrial Ltda., São Paulo, Brazil). The will measure the heart rhythm (3-lead electrocardiogram), and the R-R intervals will be used to calculate frequency and time domain indexes, in hertz (Hz) and milliseconds (ms), respectively

Other outcomes

  1. Augmentation Index (AIx) change from baseline

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

    Derived from central pressure waveforms via Complior Analyze™. Calculated as: [(Second systolic peak - First systolic peak) / Pulse pressure] × 100. Reported in %.

  2. Heart rate change from baseline

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

    Heart rate will be measured using a digital telemetry system (Polar H10™, Polar Electro Inc, Kempele, Finland) in beats per minute (bpm)

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel Gomes Ciolac, PhD

CONTACT

[email protected]

+551431039623

Junaid Riaz, Master

CONTACT

[email protected]

+5514991297853

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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