Type 2 Diabetes Mellitus (T2DM)TIDANCT07131761
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
A study testing Tai chi and Moderate-Intensity Combined Exercise (MICE) in people with Type 2 Diabetes Mellitus (T2DM), run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Tai chi and Moderate-Intensity Combined Exercise (MICE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 25 Dec 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: Effect of Tai Chi Versus Moderate-intensity Combined Exercise Training on Cardiovascular Health and Physical Functional Performance in Older Men and Women With T2DM
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.
Read more
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)
- Being tested
- Tai chi, Moderate-Intensity Combined Exercise (MICE), Control ( No Exercise )
- Keywords
- Diabetes, Type 2 Diabetes, Cardiovascular risk factor, Metabolic risk, Non communicable disease, Vascular aging
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Noncommunicable Diseases
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) | 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. Receives: Other: Control ( No Exercise ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline (week 0) and after follow-up (week 12)
Fasting Plasma Glucose
Change in fasting plasma glucose (FPG) levels (measured in mg/dL).
Measured: At baseline (week 0) and after follow-up (week 12)
Glycated Hemoglobin (HbA1c)
Change in glycated hemoglobin (HbA1c) levels (measured as % of total hemoglobin)
Measured: baseline (Week 0) to follow-up (Week 12).
Secondary outcomes (13)
Carotid-femoral pulse wave velocity (PWVcf)
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: At baseline (week 0) and after follow-up (week 12)
Brachial artery flow-mediated dilation (FMD)
Change in brachial artery flow-mediated dilation (FMD) (%), calculated as:
(peak diameter - baseline diameter) / baseline diameter × 100, measured via ultrasound (SonoSite M-Turbo™) after 5-minute artery occlusion.
Measured: At baseline (week 0) and after follow-up (week 12)
Carotid Intima-Media Thickness
CIMT will be quantified using high-resolution B-mode ultrasound (SonoSite M-Turbo®, Fujifilm Inc., USA) with a 6-13 MHz linear array transducer with participants in the supine position and head rotated 45° contralaterally.
Measured: At baseline (week 0) and after follow-up (week 12)
Central blood pressures
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: At baseline (week 0) and after follow-up (week 12)
Brachial blood pressure (BP)
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: At baseline (week 0) and after follow-up (week 12)
Heart rate variability (HRV) - frequency domain
Frequency domain of heart rate variability (HRV) 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 in hertz (Hz).
Measured: At baseline (week 0) and after follow-up (week 12)
Heart rate variability (HRV) - time domain
Time domain of heart rate variability (HRV) 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 time domain in milliseconds (ms).
Measured: from baseline (Week 0) to follow-up (Week 12)
Endurance performance
Six-minute walking test performed on a 30m flat surface. Participants walk maximally for 6 minutes with standardized encouragement. Distance recorded to nearest meter.Physiological responses (HR, SpO₂, RPE monitored) Total distance walked (meters)
Measured: At baseline (week 0) and after follow-up (week 12)
Handgrip Strength
3 trials per hand, 30s rest between trials. Instrument: Jamar Hydraulic Hand Dynamometer. Highest value (kg)
Measured: At baseline (week 0) and after follow-up (week 12)
Lower-limb muscle strength
Five-time sit to stand: Time to rise and sit from chair five times. Best time (seconds) of three trials with 30s rest.
Measured: At baseline (week 0) and after follow-up (week 12)
Mobility
Timed Up-and-Go Test (TUG): Time to rise from chair, walk 3m, turn, return, and sit.
Best time (seconds) of two trials.
Measured: At baseline (week 0) and after follow-up (week 12)
Ambulatory blood pressure monitoring (ABPM)
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: At baseline (week 0) and after follow-up (week 12)
Ambulatory heart rate variability (HRV)
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: At baseline (week 0) and after follow-up (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion25 Dec 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 Diabetes Mellitus (T2DM)Studies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Gomes Ciolac, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131761
- Sponsor's protocol ID
- 7.645.757
- Acronym
- TIDA
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 20 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07131761
- Acronym / sponsor ID
- TIDA / 7.645.757
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Diabetes, Type 2 Diabetes, Cardiovascular risk factor, Metabolic risk, Non communicable disease, Vascular aging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 20 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| 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) | Experimental | 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
Cardiovascular Health Score
Time frame: At baseline (week 0) and after follow-up (week 12)
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
Fasting Plasma Glucose
Time frame: At baseline (week 0) and after follow-up (week 12)
Change in fasting plasma glucose (FPG) levels (measured in mg/dL).
Glycated Hemoglobin (HbA1c)
Time frame: baseline (Week 0) to follow-up (Week 12).
Change in glycated hemoglobin (HbA1c) levels (measured as % of total hemoglobin)
13 secondary outcomes
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)
Ambulatory heart rate variability (HRV)
Time frame: At baseline (week 0) and after follow-up (week 12)
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 20 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 Mellitus (T2DM), 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 20 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. 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?
Cardiovascular Health Score (time frame: At baseline (week 0) and after follow-up (week 12)). The study lists 3 primary outcomes in all. 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 20 Aug 2025.