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

Official 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

Overview

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.

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

• Cardiovascular Health Score [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Fasting Plasma Glucose [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Glycated Hemoglobin (HbA1c) [Time frame: baseline (Week 0) to follow-up (Week 12).]

Secondary outcome measures (12)

• Carotid-femoral pulse wave velocity (PWVcf) [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Brachial artery flow-mediated dilation (FMD) [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Carotid Intima-Media Thickness [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Central blood pressures [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Brachial blood pressure (BP) [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Heart rate variability (HRV) - frequency domain [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Heart rate variability (HRV) - time domain [Time frame: from baseline (Week 0) to follow-up (Week 12)]
• Endurance performance [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Handgrip Strength [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Lower-limb muscle strength [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Mobility [Time frame: At baseline (week 0) and after follow-up (week 12)]
• Ambulatory blood pressure monitoring (ABPM) [Time frame: At baseline (week 0) and after follow-up (week 12)]

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

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07131761 · 7.645.757

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗