An interventional study of Tai chi and Moderate-Intensity Combined Exercise (MICE) in Type 2 Diabetes Mellitus (T2DM), sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Treatment
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 66 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Universidade Estadual Paulista Júlio de Mesquita Filho is the lead sponsor of 82 studies on the registry; 9 are open to participants now.
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only with type 2 diabetes
Exclusion Criteria:
40-60 minute supervised Yang-style Tai Chi lesson (24-form simplified pattern). Focus on calm, controlled movements and breathing coordination.
Other: Tai chi
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)
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 )
Yang style of Tai Chi (24 form)
Also known as: Tai Ji, Tai Chi Chuan
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
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.
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
Time frame: At baseline (week 0) and after follow-up (week 12)
Fasting Plasma Glucose
Change in fasting plasma glucose (FPG) levels (measured in mg/dL).
Time frame: At baseline (week 0) and after follow-up (week 12)
Glycated Hemoglobin (HbA1c)
Change in glycated hemoglobin (HbA1c) levels (measured as % of total hemoglobin)
Time frame: baseline (Week 0) to follow-up (Week 12).
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)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: At baseline (week 0) and after follow-up (week 12)
World Health Organization Quality of Life abbreviated (WHOQOL-BREF) scale
Change in health-related quality of life domains measured by the World Health Organization Quality of Life - Abbreviated Version (WHOQOL-BREF) scale (score range: 0-100), where higher scores indicate better quality of life.
Time frame: At baseline (week 0) and after follow-up (week 12)
World Health Organization Quality of Life Older Adults (WHOQOL-OLD) scale
Change in health-related quality of life domains measured by the World Health Organization Quality of Life - Older Adults (WHOQOL-OLD) scale (score range: 24-120), where higher scores indicate better quality of life.
Time frame: At baseline (week 0) and after follow-up (week 12)
Resting heart rate
Heart rate will be measured using a digital telemetry system (Polar H10™, Polar Electro Inc, Kempele, Finland) in beats per minute (bpm)
Time frame: Base line:Day 0 (before starting Tai Chi/MICE/CON) and post-intervention (Week 12)
No study locations are listed for this record.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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
Data sharing details ↗ · plataformabrasil.saude.gov.br
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Sep 2025, 1 month later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 1 month is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Universidade Estadual Paulista Júlio de Mesquita Filho