Acute Effect of Tai Chi Versus Moderate-Intensity Combined Exercise on Cardiovascular, Metabolic, and Cardiac Autonomic Control Parameters in Older Men and Women With Type 2 Diabetes Mellitus

NCT07113444 | Not Yet Recruiting DMC

• 1 other identifier: CAAE: 88582225.1.0000.5398
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type 2 diabetes mellitus (T2DM) in the elderly population is associated with compromised cardiovascular and metabolic functions, thereby necessitating the implementation of safe exercise interventions. This study employs a randomized, single-blind, crossover design will be conducted in Brazil to examine whether Tai Chi, a low-impact mind-body exercise, offers acute benefits comparable to those of moderate-intensity combined exercise (MICE) in 24 older adults (≥65 years) diagnosed with T2DM, consisting of 12 men and 12 women. Participants recruited through community advertisements and screened to ensure inactivity, stable medication usage, and the absence of significant comorbidities will undergo randomized sessions of Tai Chi, MICE, and a control (CON) intervention. Evaluations will include capillary blood glucose (the primary outcome), blood pressure, heart rate variability, arterial stiffness (PWVcf), and endothelial function (FMD) measured before, immediately after, and 45minute post-intervention, along with 24-hour ambulatory monitoring. Standardized protocols will be employed to regulate physical activity. By juxtaposing these interventions, the study seeks to ascertain if Tai Chi could serve as a feasible alternative for enhancing acute metabolic and cardiovascular responses in older diabetic adults, thus providing practical insights for clinical and lifestyle management.

Conditions

Type 2 Diabetes

Keywords

Tai Ji; Diabetes Mellitus, Type 2; Blood Glucose; Cross-Over Studies; Vascular Stiffness; Endothelium, Vascular

Outcome Measures

Primary Outcomes (1)

• Capillary blood glucose change from baseline

  Capillary blood glucose will be measured using a digital glucometer (FreeStyle Optium Neo, 163 Abbott, Oxon, UK) in milligrams per deciliter (mg/dL)

  Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)

Secondary Outcomes (7)

• Carotid-femoral pulse wave velocity (PWVcf) change from baseline

  Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)

• Brachial artery flow-mediated dilation (FMD) change from baseline

  Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)

• Central blood pressures change from baseline

  Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)

• Heart rate variability (HRV) change from baseline

  Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)

• Brachial blood pressure (BP) change from baseline

  Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)

Other Outcomes (2)

• Augmentation Index (AIx) change from baseline

  Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)

• Heart rate change from baseline

  Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)

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)

SHAM COMPARATOR

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
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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, Master

CONTACT

+5514991297853; junaid.riaz@unesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Department of Physical Education

Model Details: Crossover Model (All participants will get all interventions in random order: Tai Chi, MICE, and control.)

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 8, 2025
• Study Start: August 20, 2025
• Primary Completion: October 20, 2025
• Study Completion: November 20, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Initial data will be analysed after completing all 3 interventions .
• 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.