About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
if not able to perform physical exercise (Extreme neuropathy, wounds in the feet, and amputation risk.)
Trial design
Crossover
Treatments tested in this trial
Tai Chi
Other interventionYang style of Tai Chi (24 form)
Moderate-Intensity Combined Exercise (MICE)
Other interventionstart 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 interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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)
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
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)
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
Other outcomes
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 %.
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)
Locations
Sponsors and contacts
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Universidade Estadual Paulista Júlio de Mesquita Filho
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
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