Type 2 DiabetesNCT07113444
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
A study testing Tai Chi and Moderate-Intensity Combined Exercise (MICE) in people with Type 2 Diabetes, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tai Chi and Moderate-Intensity Combined Exercise (MICE)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- only with type 2 diabetes
Who cannot join
- if not able to perform physical exercise (Extreme neuropathy, wounds in the feet, and amputation risk.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The 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: A Randomized, Single-Blind, Crossover Controlled Trial
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
- Being tested
- Tai Chi, Moderate-Intensity Combined Exercise (MICE), Control ( No Exercise )
- Keywords
- Tai Ji, Diabetes Mellitus, Type 2, Blood Glucose, Cross-Over Studies, Vascular Stiffness, Endothelium, Vascular
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiOther
Also called Tai ji, Tai Chi Chuan
Yang style of Tai Chi (24 form)
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | 40-60 minute supervised Yang-style Tai Chi lesson (24-form simplified pattern). Focus on calm, controlled movements and breathing coordination. Receives: 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). Receives: 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. Receives: Other: Control ( No Exercise ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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
Brachial artery flow-mediated dilation (FMD) will be measured using an ultrasound device (SonoSite M-Turbo™; Fujifilm Inc., Bothell, Washington, USA), and will consist in the brachial artery diameter difference between before (baseline diameter) and after (peak diameter) the artery occlusion for 5 minutes. FMD will be expressed in percentage (%) and will be determined by the following formula: FMD (%) = (peak diameter - baseline diameter)/baseline diameter × 100
Measured: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
Central blood pressures change from baseline
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)
Measured: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
Heart rate variability (HRV) change from baseline
Heart rate variability will be assesseded using a digital telemetry system (Polar H10™, Polar Electro Inc, Kempele, Finland) to measure HR signals beat-to-beat. A sequence of 256 stable R-R intervals will be used to calculate frequency and time domain indexes, in hertz (Hz) and milliseconds (ms), respectively
Measured: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
Brachial blood pressure (BP) change from baseline
Systolic and diastolic brachial blood pressure (BP) will be measured using an automatic monitor (Omron HEM 7200™, Omron Healthcare Inc., Dalian, China) in millimeters of mercury (mmHg)
Measured: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
24-hour ambulatory blood pressure monitoring (ABPM) difference between interventions
Ambulatory systolic and diastolic blood pressure monitoring (ABPM), in millimeters of mercury (mmHg), will be measured for 24 hours after the end of each visit (approximately 90 minutes after the end of the Tai Chi, moderate-intensity combined exercise and control interventions), after a brief bath and using an automatic equipment (CardioMapa™, Cardios Sistemas Comercial e Industrial Ltda., São Paulo, Brazil).
Measured: 24 hours
24-hour heart rate variability (HRV) difference between interventions
Ambulatory heart rate variability (HRV) will be assessed for 24 hours after the end of each visit (approximately 90 minutes after the end of the Tai Chi, moderate-intensity combined exercise and control interventions), after a brief bath and using an automatic equipment (CardioMapa™, Cardios Sistemas Comercial e Industrial Ltda., São Paulo, Brazil). The will measure the heart rhythm (3-lead electrocardiogram), and the R-R intervals will be used to calculate frequency and time domain indexes, in hertz (Hz) and milliseconds (ms), respectively
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Model (All participants will get all interventions in random order: Tai Chi, MICE, and control.)
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Emmanuel Gomes Ciolac, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113444
- Sponsor's protocol ID
- CAAE: 88582225.1.0000.5398
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants who are interested in participating will provide an anamnesis to the investigator. The investigator will evaluate the IDP eligibility or non-eligibility criteria. Each qualified participant will get a document that includes the research protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code information. Thus, scientists will do cardiopulmonary activity tests to assess if IDP will be able to study the program.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 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: A Randomized, Single-Blind, Crossover Controlled Trial
- ClinicalTrials.gov ID
- NCT07113444
- Acronym / sponsor ID
- CAAE: 88582225.1.0000.5398
- Conditions
- Type 2 Diabetes
- Keywords
- Tai Ji, Diabetes Mellitus, Type 2, Blood Glucose, Cross-Over Studies, Vascular Stiffness, Endothelium, Vascular
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover Model (All participants will get all interventions in random order: Tai Chi, MICE, and control.)
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Other: Tai Chi40-60 minute supervised Yang-style Tai Chi lesson (24-form simplified pattern). Focus on calm, controlled movements and breathing coordination. |
| Moderate-Intensity Exercise (MICE) | Experimental | Other: Moderate-Intensity Combined 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). |
| Control (No Exercise) | Sham comparator | Other: 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- only with type 2 diabetes
Key exclusion criteria (1 listed)
- if not able to perform physical exercise (Extreme neuropathy, wounds in the feet, and amputation risk.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiAlso: Tai ji, Tai Chi ChuanYang style of Tai Chi (24 form) | Other | Tai Chi |
| 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 | Moderate-Intensity Exercise (MICE) |
| 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. | Other | Control (No Exercise) |
Primary outcome
Capillary blood glucose change from baseline
Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
Capillary blood glucose will be measured using a digital glucometer (FreeStyle Optium Neo, 163 Abbott, Oxon, UK) in milligrams per deciliter (mg/dL)
7 secondary outcomes
Carotid-femoral pulse wave velocity (PWVcf) change from baseline
Time frame: 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
Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
Central blood pressures change from baseline
Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
Heart rate variability (HRV) change from baseline
Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
Brachial blood pressure (BP) change from baseline
Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
24-hour ambulatory blood pressure monitoring (ABPM) difference between interventions
Time frame: 24 hours
24-hour heart rate variability (HRV) difference between interventions
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Yes. Participants who are interested in participating will provide an anamnesis to the investigator. The investigator will evaluate the IDP eligibility or non-eligibility criteria. Each qualified participant will get a document that includes the research protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code information. Thus, scientists will do cardiopulmonary activity tests to assess if IDP will be able to study the program.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Moderate-Intensity Combined Exercise (MICE) in people with Type 2 Diabetes, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Gomes Ciolac, PhD (+551431039623, emmanuel.ciolac@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary blood glucose change from baseline (time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.