The 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: A Randomized, Single-Blind, Crossover Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 24
- Primary Endpoint
- Capillary blood glucose change from baseline
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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.)
Arms & Interventions
Tai Chi
40-60 minute supervised Yang-style Tai Chi lesson (24-form simplified pattern). Focus on calm, controlled movements and breathing coordination.
Intervention: Tai Chi (Other)
Moderate-Intensity Exercise (MICE)
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).
Intervention: Moderate-Intensity Combined Exercise (MICE) (Other)
Control (No Exercise)
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.
Intervention: Control ( No Exercise ) (Other)
Outcomes
Primary Outcomes
Capillary blood glucose change from baseline
Time Frame: Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105)
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(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(Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105))
- Central blood pressures change from baseline(Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105))
- Heart rate variability (HRV) change from baseline(Baseline (minute 0), immediately after the intervention (minute 60) and 45 minutes after the intervention (minute 105))
- Brachial blood pressure (BP) change from baseline(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(24 hours)
- 24-hour heart rate variability (HRV) difference between interventions(24 hours)
Investigators
Emmanuel Gomes Ciolac
Full Professor of Department of Physical Education
Universidade Estadual Paulista Júlio de Mesquita Filho