An interventional study of Tai Chi and Moderate-Intensity Combined Exercise (MICE) in Type 2 Diabetes, 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 2025-08-08.
Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Treatment
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.
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 24 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.
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)
Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
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)
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
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
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
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: 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
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
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: 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).
Time frame: 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
Time frame: 24 hours
Augmentation Index (AIx) change from baseline
Derived from central pressure waveforms via Complior Analyze™. Calculated as: \[(Second systolic peak - First systolic peak) / Pulse pressure\] × 100. Reported in %.
Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
Heart rate change from baseline
Heart rate will be measured using a digital telemetry system (Polar H10™, Polar Electro Inc, Kempele, Finland) in beats per minute (bpm)
Time frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
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: 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.
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 Oct 2025, 2 months 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 2 months 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