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A Non-Inferiority Randomized Controlled Trial of a Digital Outdoor Exercise Program Versus Clinic-Based Rehabilitation in Obese Patients with Type 2 Diabetes

A Non-Inferiority Randomized Controlled Trial of a Digital Outdoor Exercise Program Versus Clinic-Based Rehabilitation in Obese Patients with Type 2 Diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104389
Enrollment
Unknown
Registered
2025-06-16
Start date
2022-03-14
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes with Obesity

Interventions

Digital Outdoor Exercise Program Group (Intervention Group):Exercise prescription: A combination of aerobic and resistance training programs that meet diabetes exercise guidelines. Participants were e
Face-to-face rehabilitation (control group):Exercise prescription: A combined aerobic and resistance training regimen similar to the digital arm to ensure that both groups get the same "dose" of exerc

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
37 Years to 58 Years

Inclusion criteria

Inclusion criteria: 1. Adults (18-70 years old) have been diagnosed with type 2 diabetes (according to ADA standards) for at least 1 year. 2.Obesity is defined as BMI>=28 kg/m^2 (using Chinese obesity standards). 3. hba1c between 7% and 10% at screening (to ensure there is room for improvement in blood sugar control). A sedentary or low-activity lifestyle (not meeting 4.the moderate exercise recommendation of >=150 minutes per week in the last 3 months). 5. Moderate intensity exercise approved by a physician (no uncontrolled cardiovascular disease or other exercise contraindications). 6. Own a smartphone or tablet computer with basic proficiency (for people in digital intervention). 7. Willing to participate in any intervention group and attend follow-up.

Exclusion criteria

Exclusion criteria: 1.Type 1 diabetes or secondary diabetes (with a focus on management of type 2 diabetes). 2.Severe diabetic complications that hinder safe exercise: proliferative retinopathy, advanced neuropathy with frequent falls, active diabetic foot ulcers. 3.Significant cardiovascular disease, uncontrolled or high-risk exercise (e.g., recent myocardial infarction <6 months, unstable angina, uncontrolled hypertension, blood pressure 180/100 mmHg, grade III-IV heart failure). 4.Severe musculoskeletal or joint diseases that limit activity or movement (e.g., severe osteoarthritis, lower limb amputation, and lack of proper prosthetics). 5.Chronic kidney disease stage 4-5 or other serious comorbidities that interfere with exercise or study participation. 6.Pregnant or planning to become pregnant in the next 6 months (due to changes in exercise risks and metabolic needs). 7.Currently enrolled in another organized weight loss, exercise, or diabetes management program. 8. Inability to commit to 12-week plans or expected non-compliance (e.g., frequent travel, lack of phone/Internet access to digital groups).

Design outcomes

Primary

MeasureTime frame
HbA1c;Adverse events;

Secondary

MeasureTime frame
Body Mass Index;Body fat percentage;Blood Pressure;Lipid profile;30s sit-to-stand;SF-36;

Countries

China

Contacts

Public ContactHuang Li Hua

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

huanglihua906@163.com+86 189 3975 9175

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026