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

NCT ID: NCT07131761

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2025-12-25

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tai Chi

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

Group Type: EXPERIMENTAL

Tai chi

Intervention Type: OTHER

Yang style of Tai Chi (24 form)

Moderate-Intensity Exercise (MICE)

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).

Group Type: EXPERIMENTAL

Moderate-Intensity Combined Exercise (MICE)

Intervention Type: 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)

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.

Group Type: EXPERIMENTAL

Control ( No Exercise )

Intervention Type: 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.

Interventions

Tai chi

Yang style of Tai Chi (24 form)

Intervention Type: 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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Tai Ji; Tai Chi Chuan

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.)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Emmanuel Gomes Ciolac

Full Professor of Department of Physical Education

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Emmanuel Gomes Ciolac, PhD

Role: CONTACT

emmanuel.ciolac@unesp.br

+551431039623

Junaid Riaz, MSc

Role: CONTACT

junaid.riaz@unesp.br

+5514991297853

Other Identifiers

7.645.757

Identifier Type: -

Identifier Source: org_study_id