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NCT Number: NCT07131761

Effect of Tai Chi Versus Moderate-intensity Combined Exercise Training on Cardiovascular Health and Physical Functional Performance in Older Men and Women With T2DM: the Tai Chi Intervention for Diabetes Management During Aging (TIDA) Study

This randomized, single-blind, controlled clinical trial compares the effects of a 12-week Tai Chi program versus moderate-intensity combined exercise (MICE) training on cardiovascular health, glycemic control, and physical function in older adults with type 2 diabetes (T2DM). Sixty-six participants (33 men and 33 women) will be randomized 1:1:1 to Tai Chi (n = 22), MICE (n = 22), or a non-exercise control group (CON, n = 22).

The Tai Chi intervention involves three weekly Yang-style sessions, progressively increasing in duration and complexity while maintaining perceived exertion (PSE) below 12 (6-20 scale). The MICE program combines moderate-intensity walking (PSE 12-13) with six strengthening exercises (PSE 12-14), gradually increasing from 15 to 30 minutes/session and 1 to 3 sets over 12 weeks.

Primary outcomes include cardiovascular health (Life's Essential 8 index: diet, physical activity, nicotine exposure, sleep, BMI, lipids, blood glucose, and blood pressure) and glycemic control (fasting glucose, HbA1c). Secondary outcomes assess physiological mechanisms (heart rate variability, pulse wave velocity, flow-mediated dilation, carotid intima-media thickness), physical performance (6-minute walk test, grip strength, timed up-and-go), and quality of life (WHOQOL-BREF/OLD).

All evaluations will be conducted by blinded assessors under standardized conditions (21-24°C, morning fasting), except the 6MWT. Statistical analysis includes intention-to-treat repeated-measures ANOVA, ANCOVA for baseline adjustments, and per-protocol/adherence-adjusted analyses. Sample size (GPower) was calculated to detect a 0.8% HbA1c reduction with 90% power (30% attrition accounted for). An interim analysis at 50% completion will evaluate effect sizes/variability, with potential sample-size recalibration by an independent committee.

The study employs rigorous quality controls: standardized protocols, blinded assessments, and monitoring of confounders (medication changes, acute exercise effects). Ethical approval (CAAE: 88582225.1.0000.5398) ensures adherence to informed consent and privacy. By determining whether Tai Chi offers comparable or superior benefits to MICE for cardio metabolic health and functional capacity, this trial aims to inform evidence-based exercise prescriptions for older T2DM patients.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Noncommunicable Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

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. Cardiovascular Health Score

    Time frame: At baseline (week 0) and after follow-up (week 12)

    Life's Essential 8 Index (0-100 scale)

    Components:

    Health behaviors: Diet, physical activity, nicotine exposure, sleep quality Health factors: BMI, blood lipids, blood glucose, blood pressure

  2. Fasting Plasma Glucose

    Time frame: At baseline (week 0) and after follow-up (week 12)

    Change in fasting plasma glucose (FPG) levels (measured in mg/dL).

  3. Glycated Hemoglobin (HbA1c)

    Time frame: baseline (Week 0) to follow-up (Week 12).

    Change in glycated hemoglobin (HbA1c) levels (measured as % of total hemoglobin)

Secondary outcomes

  1. Carotid-femoral pulse wave velocity (PWVcf)

    Time frame: At baseline (week 0) and after follow-up (week 12)

    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)

    Time frame: At baseline (week 0) and after follow-up (week 12)

    Change in brachial artery flow-mediated dilation (FMD) (%), calculated as:

    (peak diameter - baseline diameter) / baseline diameter × 100, measured via ultrasound (SonoSite M-Turbo™) after 5-minute artery occlusion.

  3. Carotid Intima-Media Thickness

    Time frame: At baseline (week 0) and after follow-up (week 12)

    CIMT will be quantified using high-resolution B-mode ultrasound (SonoSite M-Turbo®, Fujifilm Inc., USA) with a 6-13 MHz linear array transducer with participants in the supine position and head rotated 45° contralaterally.

  4. Central blood pressures

    Time frame: At baseline (week 0) and after follow-up (week 12)

    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)

  5. Brachial blood pressure (BP)

    Time frame: At baseline (week 0) and after follow-up (week 12)

    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. Heart rate variability (HRV) - frequency domain

    Time frame: At baseline (week 0) and after follow-up (week 12)

    Frequency domain of heart rate variability (HRV) 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 in hertz (Hz).

  7. Heart rate variability (HRV) - time domain

    Time frame: from baseline (Week 0) to follow-up (Week 12)

    Time domain of heart rate variability (HRV) 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 time domain in milliseconds (ms).

  8. Endurance performance

    Time frame: At baseline (week 0) and after follow-up (week 12)

    Six-minute walking test performed on a 30m flat surface. Participants walk maximally for 6 minutes with standardized encouragement. Distance recorded to nearest meter.Physiological responses (HR, SpO₂, RPE monitored) Total distance walked (meters)

  9. Handgrip Strength

    Time frame: At baseline (week 0) and after follow-up (week 12)

    3 trials per hand, 30s rest between trials. Instrument: Jamar Hydraulic Hand Dynamometer. Highest value (kg)

  10. Lower-limb muscle strength

    Time frame: At baseline (week 0) and after follow-up (week 12)

    Five-time sit to stand: Time to rise and sit from chair five times. Best time (seconds) of three trials with 30s rest.

  11. Mobility

    Time frame: At baseline (week 0) and after follow-up (week 12)

    Timed Up-and-Go Test (TUG): Time to rise from chair, walk 3m, turn, return, and sit.

    Best time (seconds) of two trials.

  12. Ambulatory blood pressure monitoring (ABPM)

    Time frame: At baseline (week 0) and after follow-up (week 12)

    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).

  13. Ambulatory heart rate variability (HRV)

    Time frame: At baseline (week 0) and after follow-up (week 12)

    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).

Other outcomes

  1. World Health Organization Quality of Life abbreviated (WHOQOL-BREF) scale

    Time frame: At baseline (week 0) and after follow-up (week 12)

    Change in health-related quality of life domains measured by the World Health Organization Quality of Life - Abbreviated Version (WHOQOL-BREF) scale (score range: 0-100), where higher scores indicate better quality of life.

  2. World Health Organization Quality of Life Older Adults (WHOQOL-OLD) scale

    Time frame: At baseline (week 0) and after follow-up (week 12)

    Change in health-related quality of life domains measured by the World Health Organization Quality of Life - Older Adults (WHOQOL-OLD) scale (score range: 24-120), where higher scores indicate better quality of life.

  3. Resting heart rate

    Time frame: Base line:Day 0 (before starting Tai Chi/MICE/CON) and post-intervention (Week 12)

    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, MSc

CONTACT

[email protected]

+5514991297853

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

Effect of Tai Chi Versus Moderate-intensity Combined Exercise Training on Cardiovascular Health and Physical Functional Performance in Older Men and Women With T2DM

Acronym: TIDA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2025
Registry last updated
Aug 20, 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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