Tai Chi in type 2 diabetes

ISRCTN	ISRCTN18233037
DOI	https://doi.org/10.1186/ISRCTN18233037
Sponsors	Centrum Medyczne Provita, Upper Silesian Academy in Katowice
Funder	Centrum Medyczne Provita

Submission date: 14/02/2026
Registration date: 16/02/2026
Last edited: 16/02/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study looks at whether doing a gentle form of exercise called Tai Chi can help people aged 50 or older who have type 2 diabetes. It also tests whether a technique called ischemic preconditioning, which temporarily reduces blood flow to the legs using inflatable cuffs, can make the benefits of Tai Chi stronger. The main aim is to find out whether these approaches can help improve long‑term blood sugar levels. The study will also look at blood vessel health, body measurements, how well people stick to the exercise plan, and safety.

Who can participate?
People can take part if they are aged 50 years or older, have had type 2 diabetes for at least six months, and have not changed their diabetes medication in the past three months. They must be able to walk on their own and safely take part in low‑intensity exercise. They should not already be doing regular structured exercise. People cannot join if they have certain medical conditions such as unstable heart disease, recent stroke or heart attack, severe high blood pressure, advanced circulation problems, or other conditions that would make the procedures unsafe.

What does the study involve?
Participants will be randomly placed into one of four groups: usual care, Tai Chi only, Tai Chi with ischemic preconditioning, or Tai Chi with a sham (inactive) cuff procedure. Those in a Tai Chi group will attend three supervised sessions each week for 12 weeks. Each session lasts 45 minutes and includes warm‑up, Tai Chi movements adapted for older adults, and cool‑down. In the ischemic preconditioning group, a 30‑minute cuff procedure will take place before each Tai Chi session. All participants will complete health and laboratory assessments at the start, after 12 weeks, and again four weeks later.

What are the possible benefits and risks of participating?
The study may help participants improve their fitness, balance, and blood sugar control, although this cannot be guaranteed. The risks are low because the exercises are gentle and supervised. The cuff procedure may cause temporary discomfort or pressure in the legs. All procedures are monitored by trained staff to keep participants safe.

Where is the study run from?
The study is being carried out in Żory, Poland, at Medical Center Provita and the Inżbud Octagon Sports Club.

When is the study starting and how long is it expected to run for?
The first participants are expected to join the study in March 2026. The exercise programme lasts 12 weeks for each person, with an extra follow‑up check four weeks later. The whole study is expected to finish by November 2026.

Who is funding the study?
The study is funded by Centrum Medyczne Provita (Poland)

Who is the main contact?
Mr Robert Trybulski rtrybulski.provita@gmail.com

Contact information

Mr ROBERT TRYBULSKI
Public, Scientific, Principal investigator

al.Zjednoczonej Europy
37
Żory
44-240
Poland

ORCID ID	0000-0002-4276-4813
Phone	+48 502591428
Email	rtrybulski.provita@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Prevention, Treatment
Participant information sheet	49035 PIS zal.-nr-5-wniosek-do-KEBNF.pdf
Scientific title	The effect of Tai Chi exercises with ischemic preconditioning on glycemic control in individuals aged ≥50 years with type 2 diabetes – a randomized controlled trial
Study acronym	Tai Chi - Dt2
Study objectives	Primary Objective To determine whether ischemic preconditioning (IPC) applied prior to Tai Chi exercise leads to a greater improvement in glycemic control, as measured by glycated hemoglobin (HbA1c), in individuals aged ≥50 years with type 2 diabetes mellitus, compared to Tai Chi alone, sham IPC, or usual care Secondary Objectives 1. To assess the effects of the intervention on microvascular function using the post-occlusive reactive hyperemia (PORH) test with laser Doppler flowmetry 2. To evaluate changes in anthropometric parameters, including body mass, BMI, and waist circumference 3. To assess exercise intensity, adherence to the training program, and safety outcomes, including adverse events 4. To determine whether the observed effects persist at a 4-week follow-up after completion of the intervention The study aims to provide high-quality clinical evidence regarding the potential of combining a safe, low-intensity exercise modality (Tai Chi) with a non-invasive physiological intervention (IPC) to enhance metabolic and vascular outcomes in older adults with type 2 diabetes
Ethics approval(s)	Approved 04/01/2026, Research Ethics Committee of Physiotherapists at the Polish Physiotherapy Association (Correspondence Address:, Centrum Rehabilitacji Funkcjonalnej ORTHOS, ul. Z. Modzelewskiego 37, unit U8, Warsaw, 02-679, Poland; + 48 601 300 080; Email: biuro@fizjoterapeuci.org), ref: No. 4/01/2026
Health condition(s) or problem(s) studied	Type 2 diabetes
Intervention	The intervention consists of a 12-week supervised exercise program with or without ischemic preconditioning (IPC), depending on group allocation Tai Chi Program Participants assigned to the Tai Chi groups will attend supervised group sessions three times per week for 12 consecutive weeks. Each session will last 45 minutes and will be conducted by a qualified physiotherapist or certified Tai Chi instructor under controlled conditions Each session will include: 10 minutes of warm-up and mobility exercises, 30 minutes of modified Yang-style Tai Chi (therapeutic simplified form, 8–12 movements adapted for individuals aged ≥50 years, avoiding deep stances and rapid rotations), 5 minutes of cool-down and breathing exercises Exercise intensity will be monitored using the Borg Rating of Perceived Exertion (6–20 scale), the talk test, and heart rate monitoring in a subgroup of participants Ischemic Preconditioning (IPC) In the IPC → Tai Chi group, a 30-minute IPC session will be performed immediately before each Tai Chi session IPC will be administered using a pneumatic tourniquet system (Delfi Personalized Tourniquet System). Occlusion cuffs (12 cm width) will be placed proximally on both lower limbs. Individual arterial occlusion pressure (AOP) will be determined for each participant prior to the intervention. The working IPC pressure will be set at 100% of the individually determined AOP The IPC protocol will follow a standard ischemia–reperfusion sequence: 5 minutes of arterial occlusion, 5 minutes of reperfusion, repeated three times (total duration: 30 minutes) Participants will remain seated or supine during the procedure, and their well-being will be continuously monitored. Sham IPC In the SHAM → Tai Chi group, a sham procedure will be applied before each Tai Chi session. The procedure will be identical in duration and setup; however, cuff pressure will be set at 20 mmHg, which does not induce arterial occlusion or physiological IPC effects Usual Care Group Participants assigned to the usual care group will maintain their habitual lifestyle and physical activity level without participation in the supervised Tai Chi program All interventions are non-invasive, supervised, and conducted under standardized safety procedures. Participants will be randomly allocated to study groups using a computer-generated randomisation sequence. The allocation sequence will be generated using an online randomisation tool to ensure true randomness. Group assignments will be implemented using sealed, opaque, sequentially numbered envelopes prepared in advance by an independent member of the research team who is not involved in participant recruitment or outcome assessment. This procedure ensures allocation concealment and minimises selection bias. Randomisation will follow a 1:1 allocation ratio between the intervention and control groups.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Glycated hemoglobin (HbA1c, %) measured using certified laboratory high-performance liquid chromatography (HPLC) method at baseline (T0) and after 12 weeks (T2) 2. Microvascular peak hyperemic response (PORH peak value) measured using laser Doppler flowmetry (PeriFlux System, Perimed) during the Post-Occlusive Reactive Hyperemia (PORH) test at baseline (T0), after 12 weeks (T2), and 4-week follow-up (T3) 3. Resting microcirculatory flow (REST FLOW) measured using laser Doppler flowmetry (PeriFlux System, Perimed) during the PORH test at baseline (T0), after 12 weeks (T2), and 4-week follow-up (T3) 4. Time to peak hyperemic response (PORH parameter) measured using laser Doppler flowmetry (PeriFlux System, Perimed) at baseline (T0), after 12 weeks (T2), and 4-week follow-up (T3) 5. Recovery time of microcirculatory flow (PORH parameter) measured using laser Doppler flowmetry (PeriFlux System, Perimed) at baseline (T0), after 12 weeks (T2), and 4-week follow-up (T3) measured using Primary Outcome Glycated hemoglobin (HbA1c, %) measured using a certified laboratory high-performance liquid chromatography (HPLC) assay, expressed as percentage (%), assessed at baseline (T0) and after 12 weeks of intervention (T2). ✅ Secondary Outcomes Peak hyperemic response (perfusion units, PU) measured using laser Doppler flowmetry (PeriFlux System, Perimed) during the Post-Occlusive Reactive Hyperemia (PORH) test, assessed at baseline (T0), post-intervention (T2), and 4-week follow-up (T3). Resting microvascular blood flow (perfusion units, PU) measured using laser Doppler flowmetry (PeriFlux System, Perimed) during the PORH protocol, assessed at T0, T2, and T3. Time to peak hyperemic response (seconds) measured using laser Doppler flowmetry (PeriFlux System, Perimed) during the PORH test, assessed at T0, T2, and T3. Microvascular recovery time (seconds) measured using laser Doppler flowmetry (PeriFlux System, Perimed) during the PORH test, assessed at T0, T2, and T3. at Time Points Description T0 – Baseline Assessment (Week 0) Conducted within 7 days prior to randomization and before initiation of any study intervention. All primary and secondary outcome measures are assessed at this time point. Participants are in a stable clinical condition and have not yet started the 12-week intervention program. T2 – Post-Intervention Assessment (Week 12 ± 7 days) Conducted immediately after completion of the 12-week intervention period. All primary and secondary outcome measures are reassessed to determine the effect of the intervention. Measurements are performed within 7 days after the final exercise session. T3 – Follow-Up Assessment (Week 16 ± 7 days) Conducted 4 weeks after completion of the intervention to evaluate the persistence of observed effects. No supervised exercise or IPC procedures are performed during this period. All secondary vascular and anthropometric outcomes are reassessed. HbA1c may also be measured to assess sustained glycemic changes.
Key secondary outcome measure(s)	Glycated hemoglobin (HbA1c, %) measured using a certified laboratory high‑performance liquid chromatography (HPLC) assay at baseline (T0) and after 12 weeks (T2) Peak hyperemic response (perfusion units) measured using laser Doppler flowmetry during the Post‑Occlusive Reactive Hyperemia (PORH) test at baseline (T0), after 12 weeks (T2), and at 4‑week follow‑up (T3) Resting microvascular blood flow (perfusion units) measured using laser Doppler flowmetry during the PORH protocol at baseline (T0), after 12 weeks (T2), and at 4‑week follow‑up (T3) Time to peak hyperemic response (seconds) measured using laser Doppler flowmetry during the PORH test at baseline (T0), after 12 weeks (T2), and at 4‑week follow‑up (T3) Microvascular recovery time (seconds) measured using laser Doppler flowmetry during the PORH test at baseline (T0), after 12 weeks (T2), and at 4‑week follow‑up (T3) Resting systolic and diastolic blood pressure (mmHg) measured using an automated validated sphygmomanometer at baseline (T0), after 12 weeks (T2), and at 4‑week follow‑up (T3) Body mass (kg) measured using a calibrated digital scale at baseline (T0), after 12 weeks (T2), and at 4‑week follow‑up (T3) Body mass index (kg/m²) measured using calculated values from measured height and body mass at baseline (T0), after 12 weeks (T2), and at 4‑week follow‑up (T3) Waist circumference (cm) measured using standard anthropometric tape at baseline (T0), after 12 weeks (T2), and at 4‑week follow‑up (T3) Perceived exercise intensity (Borg RPE 6–20 score) measured using the Borg Rating of Perceived Exertion scale at after each training session during the 12‑week intervention period Heart rate (beats per minute) measured using wrist‑worn smartwatch heart rate monitors at during selected training sessions throughout the 12‑week intervention period Adherence rate (%) measured using attendance records at the end of the 12‑week intervention period (T2) Adverse events (number and type) measured using standardized adverse event documentation forms at baseline (T0) through post‑intervention (T2) and follow‑up (T3)
Completion date	30/11/2026

Eligibility

Participant type(s)
Age group	Senior
Lower age limit	100 Years
Upper age limit	200 Years
Sex	All
Target sample size at registration	60
Total final enrolment	120
Key inclusion criteria	1. Individuals aged ≥50 years (no upper age limit, provided that clinical status allows safe participation). 2. Diagnosed with type 2 diabetes mellitus (T2DM) according to current diagnostic criteria. 3. Duration of diabetes of at least 6 months. 4. No changes in antidiabetic treatment (type of medication or dosage) for at least 3 months prior to study enrolment. 5. No planned changes in pharmacological treatment during the 12-week intervention period. 6. No regular exercise habits, defined as: 6.1. No structured training-type physical activity ≥1 session per week during the past 3–6 months. 6.2. Occasional low-intensity recreational activity (e.g., walking) is permitted. 7. Ability to ambulate independently. 8. Ability to safely participate in low- to moderate-intensity exercise (Tai Chi) as assessed by a qualifying physician or physiotherapist. 9. Signed informed consent to participate in the study. 10. Consent to undergo laboratory testing and clinical measurements.
Key exclusion criteria	1. Cardiovascular and Systemic Contraindications 1.1. Unstable coronary artery disease. 1.2. Myocardial infarction or stroke within <6 months prior to enrollment. 1.3. Uncontrolled arterial hypertension (resting SBP ≥180 mmHg or DBP ≥110 mmHg). 1.4. Severe heart failure (New York Heart Association [NYHA] class III–IV). 2. Vascular and Neurological Conditions 2.1. Diagnosed advanced peripheral artery disease (PAD) with symptoms of critical limb ischemia. 2.2. Active lower-limb ulcers, trophic changes, or infections. 2.3. Severe diabetic neuropathy with significant impairment of pain or pressure sensation. 2.4. Other neurological disorders that may interfere with the safe performance of exercise (e.g., advanced Parkinson’s disease). 3. Contraindications to Ischemic Preconditioning (IPC) 3.1. History of deep vein thrombosis (DVT) or pulmonary embolism. 3.2. Known coagulation disorders. 3.3. Significant lower-limb vascular disease preventing the safe use of occlusion cuffs (e.g., advanced atherosclerosis; ankle–brachial index [ABI] <0.75 or >1.10). 3.4. Intolerance to limb compression or significant pain during the preliminary IPC procedure test. 4. Orthopedic and Functional Contraindications 4.1. Acute inflammation, injury, or exacerbation of musculoskeletal disorders. 4.2. Significant mobility limitations or deformities preventing the performance of Tai Chi exercises, even in a modified form. 4.3. Recent surgery (<6 months). 5. Other Exclusion Factors 5.1. Active malignancy under current treatment. 5.2. Severe cognitive impairment or psychiatric disorders preventing informed participation. 5.3. Participation in another clinical trial or interventional study within the past 3 months. 5.4. Lack of informed consent or withdrawal of consent at any stage of the study.Adherence Criterion: Participants are required to attend at least 70% of the scheduled exercise sessions. Individuals whose attendance falls below 70% of the total planned sessions during the 12-week intervention will be excluded from the final analysis.
Date of first enrolment	09/03/2026
Date of final enrolment	30/03/2026

Locations

Countries of recruitment

Poland

Study participating centres

Medical Center Provita

37 United Europe Avenue
Żory
44-240
Poland

Inżbud Octagon Sports Club

28 Szeroka Street
Żory
44-240
Poland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	in Polish		16/02/2026	No	Yes
Protocol file			16/02/2026	No	No

Additional files

49035 PIS zal.-nr-5-wniosek-do-KEBNF.pdf: in Polish
49035 Protocol.pdf: Protocol file

Editorial Notes

16/02/2026: Trial's existence confirmed by Research Ethics Committee of Physiotherapists at the Polish Physiotherapy Association.