Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Diabetes, Type 2 Diabetes, Cardiovascular risk factor, Metabolic risk, Non communicable disease, Vascular aging
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.
Interventions
OTHERTai chi
Yang style of Tai Chi (24 form)
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.
Sponsors
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin (HbA1c) | baseline (Week 0) to follow-up (Week 12). | Change in glycated hemoglobin (HbA1c) levels (measured as % of total hemoglobin) |
| Fasting Plasma Glucose | At baseline (week 0) and after follow-up (week 12) | Change in fasting plasma glucose (FPG) levels (measured in mg/dL). |
| Cardiovascular Health Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotid Intima-Media Thickness | At baseline (week 0) and after follow-up (week 12) | 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. |
| Heart rate variability (HRV) - time domain | from baseline (Week 0) to follow-up (Week 12) | 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). |
| Endurance performance | At baseline (week 0) and after follow-up (week 12) | 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) |
| Central blood pressures | At baseline (week 0) and after follow-up (week 12) | 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) |
| Heart rate variability (HRV) - frequency domain | At baseline (week 0) and after follow-up (week 12) | 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). |
| Handgrip Strength | At baseline (week 0) and after follow-up (week 12) | 3 trials per hand, 30s rest between trials. Instrument: Jamar Hydraulic Hand Dynamometer. Highest value (kg) |
| Lower-limb muscle strength | At baseline (week 0) and after follow-up (week 12) | Five-time sit to stand: Time to rise and sit from chair five times. Best time (seconds) of three trials with 30s rest. |
| Mobility | At baseline (week 0) and after follow-up (week 12) | Timed Up-and-Go Test (TUG): Time to rise from chair, walk 3m, turn, return, and sit. Best time (seconds) of two trials. |
| Ambulatory blood pressure monitoring (ABPM) | At baseline (week 0) and after follow-up (week 12) | 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). |
| Ambulatory heart rate variability (HRV) | At baseline (week 0) and after follow-up (week 12) | 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). |
| Brachial blood pressure (BP) | At baseline (week 0) and after follow-up (week 12) | 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) |
| Carotid-femoral pulse wave velocity (PWVcf) | At baseline (week 0) and after follow-up (week 12) | 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) |
| Brachial artery flow-mediated dilation (FMD) | At baseline (week 0) and after follow-up (week 12) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Quality of Life abbreviated (WHOQOL-BREF) scale | At baseline (week 0) and after follow-up (week 12) | 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. |
| Resting heart rate | Base line:Day 0 (before starting Tai Chi/MICE/CON) and post-intervention (Week 12) | Heart rate will be measured using a digital telemetry system (Polar H10™, Polar Electro Inc, Kempele, Finland) in beats per minute (bpm) |
| World Health Organization Quality of Life Older Adults (WHOQOL-OLD) scale | At baseline (week 0) and after follow-up (week 12) | 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. |
Contacts
Primary ContactEmmanuel Gomes Ciolac, PhD
Backup ContactJunaid Riaz, MSc
Outcome results
None listed