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.
None
if not able to perform physical exercise (Extreme neuropathy, wounds in the feet, and amputation risk.)
Parallel
Tai chi
Other interventionYang style of Tai Chi (24 form)
Moderate-Intensity Combined Exercise (MICE)
Other interventionstart 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 interventionThe 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.
Cardiovascular Health Score
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
Fasting Plasma Glucose
Change in fasting plasma glucose (FPG) levels (measured in mg/dL).
Glycated Hemoglobin (HbA1c)
Change in glycated hemoglobin (HbA1c) levels (measured as % of total hemoglobin)
Carotid-femoral pulse wave velocity (PWVcf)
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)
Brachial artery flow-mediated dilation (FMD)
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.
Carotid Intima-Media Thickness
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.
Central blood pressures
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)
World Health Organization Quality of Life abbreviated (WHOQOL-BREF) scale
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.
World Health Organization Quality of Life Older Adults (WHOQOL-OLD) scale
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.
Resting heart rate
Heart rate will be measured using a digital telemetry system (Polar H10™, Polar Electro Inc, Kempele, Finland) in beats per minute (bpm)
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