Acute Effect of Tai Chi Versus Moderate-Intensity Combined Exercise on Cardiovascular, Metabolic, and Cardiac Autonomic Control Parameters in Older Men and Women With Type 2 Diabetes Mellitus

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversidade Estadual Paulista Júlio de Mesquita Filho

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 volunteers

Qualifiers

None

Disqualifiers

if not able to perform physical exercise (Extreme neuropathy, wounds in the feet, and amputation risk.)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Tai Chi

    Other intervention

    Yang style of Tai Chi (24 form)

  • Moderate-Intensity Combined Exercise (MICE)

    Other intervention

    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 intervention

    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.

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Tai ChiExperimental treatment 1 intervention
Group B: Moderate-Intensity Exercise (MICE)Experimental treatment 1 intervention
Group C: Control (No Exercise)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

1

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)
2

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)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Estadual Paulista Júlio de Mesquita Filho

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator

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