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

NCT07131761 | Not Yet Recruiting DMC

• 1 other identifier: 7.645.757
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabetes; Type 2 Diabetes; Cardiovascular risk factor; Metabolic risk; Non communicable disease; Vascular aging

Outcome Measures

Primary Outcomes (3)

• 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

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

• Fasting Plasma Glucose

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

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

• Glycated Hemoglobin (HbA1c)

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

  baseline (Week 0) to follow-up (Week 12).

Secondary Outcomes (13)

• Carotid-femoral pulse wave velocity (PWVcf)

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

• Brachial artery flow-mediated dilation (FMD)

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

• Carotid Intima-Media Thickness

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

• Central blood pressures

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

• Brachial blood pressure (BP)

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

Other Outcomes (3)

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

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

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

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

• Resting heart rate

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

Study Arms (3)

Tai Chi

EXPERIMENTAL

40-60 minute supervised Yang-style Tai Chi lesson (24-form simplified pattern). Focus on calm, controlled movements and breathing coordination.

Other: Tai chi

Moderate-Intensity Exercise (MICE)

EXPERIMENTAL

The MICE session will consist of five minutes of warm-up (joint mobility and stretching exercises between PSE levels 9 and 11, 30 minutes of walking on the treadmill between PSE levels 12 and 13, 20 minutes of muscle strengthening exercises between levels 12 and 14 of PSE (two sets of 15 to 20 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 five minutes of back to calm (light stretching and breathing exercises at PSE level 9).

Other: Moderate-Intensity Combined Exercise (MICE)

Control (No Exercise)

EXPERIMENTAL

The CON session will consist of 60 minutes of rest in the sitting position. Participants will be told not to sleep and will not have access to reading or electronic devices during the CON session.

Other: Control ( No Exercise )

Interventions

Tai chi OTHER

Yang style of Tai Chi (24 form)

Also known as: Tai Ji, Tai Chi Chuan

Tai Chi

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

Moderate-Intensity Exercise (MICE)

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.

Control (No Exercise)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• only with type 2 diabetes

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Noncommunicable Diseases

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Emmanuel Gomes Ciolac, PhD

CONTACT

+551431039623; emmanuel.ciolac@unesp.br

Junaid Riaz, MSc

CONTACT

+5514991297853; junaid.riaz@unesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Department of Physical Education

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 20, 2025
• Study Start: August 20, 2025
• Primary Completion: September 20, 2025
• Study Completion: December 25, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be analysed after completing all 3 interventions (12week).
• Access Criteria: Informed Consent Form described and signed. DP will received Informed Consent Form informing the objectives, study deling, interventions, analyses, risks and benefits. Participation in this study will be voluntary and confidential after signing of an informed consent