Evaluate the Effect of Remote Exercise Intervention on Blood Glucose Control and Physical Fitness in T2DM Patients

NCT07676773 | Recruiting

• 2 other identifiers: SichuanAMS-2023QN152023QN15
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The intervention group received 12 weeks of continuous remote intervention combined with health education. The control group only received 12 weeks of continuous health education, and the content and frequency were the same as those of the management group. Both groups received instruction at the beginning of the intervention. The intervention group was given priority to continuous walking/running combined with aerobic exercise and swimming. Five to seven sessions per week for 45 minutes each session. Acclimatizations were performed at an intensity of 40%-49% reserve oxygen uptake (VO2R) from weeks 1 to 4, and exercise was performed at an intensity of 50%-59% VO2R from weeks 5 to 12. 5 minutes each of preparation and grooming activities (including joint movement and stretching) for each exercise. Combined with incremental load resistance exercise 2-3 times a week, 8 movements, 2-3 groups each time, repeated 8-10 times/group, with a 2-min rest between groups. The heart rate, RPE (12-13, "fairly easy" to "somewhat laborious") and exercise bracelet were used to monitor the intensity and amount of exercise. The exercise intervention was usually delivered 1-2 h after a meal. The daily medical supervision in the process of management implementation was carried out by trained sports managers through the doctor terminal of "exercise assistant" to collect and monitor the data of the study subjects.

Conditions

Diabete Type 2; Cardio Respiratory Fitness

Keywords

Type 2 diabetes mellitus; Integration of sports and healthcare; Randomized controlled trial; Exercise prescription; Remote exercise intervention

Outcome Measures

Primary Outcomes (1)

• Change in glycemic control

  Fasting plasma glucose (FPG), 2-hour post-load glucose, and glycated hemoglobin (HbA1c) will be measured at baseline and after 12 weeks of intervention to assess glycemic control. Changes from baseline will be compared between the exercise and control groups.

  Baseline and 12 weeks

Study Arms (2)

Remote Exercise Management

EXPERIMENTAL

Participants receive 12-week personalized remote exercise intervention (aerobic + resistance) based on FITT-VP principles, monitored via wearable devices, along with standard health education.

Behavioral: Remote Exercise + Health Education; Behavioral: Health Education

Education

OTHER

Health education on DM and Exercise

Behavioral: Health Education

Interventions

Health Education BEHAVIORAL

12-week standard diabetes health education (medical knowledge, diet/exercise advice, complications, mental health) with same frequency/content as experimental group, but without remote exercise.

Education; Remote Exercise Management

Remote Exercise + Health Education BEHAVIORAL

Participants in this arm receive a 12-week personalized remote exercise program based on the FITT-VP principle (Frequency: 5-7 days/week; Intensity: 40-59% VO₂R; Time: 45 min/session + 5-min warm-up/cool-down; Type: aerobic walking/jogging plus resistance training with elastic bands twice weekly). Exercise is monitored via wearable devices and a mobile APP , with feedback and adjustments by trained exercise managers. All participants also receive standard diabetes health education (same content and frequency as the control group).

Remote Exercise Management

Eligibility Criteria

• Age: 18 Years - 69 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Both gender, age from 40 to 69 years old. (2) Meeting the diagnostic criteria for type 2 diabetes in China. (3) HbA1c is within 6.5%-7 .0% and no medication is taken. (4) Newly diagnosed with diabetes or the duration of the disease is no more than 5 years. (5) Possessing general exercise capacity and no obvious diseases in the muscle and osteoarticular systems. (6) The exercise risk is evaluated as medium or low risk through the PAR-Q+ questionnaire. (7) No contraindications to exercise tests. (8) Willing to adopt intensifed lifestyle intervention and complete the entire research process.

You may not qualify if:

• (1) T1DM patients, autoimmune diabetes and special types of diabetes, including hypercortisolism, growth hormone tumor, glucagonoma and some special types of diabetes caused by genetic factors; (2) pregnant or lactating women; (3) regular use of antidiabetic drugs or insulin in the past three months; (4) fasting blood glucose level \> 16.7 mmol/L; (5) recurrent hypoglycemia; (6) a history of acute diabetic complications, including diabetic ketoacidosis, hyperosmolar hyperglycemia, and lactic acidosis; (7) a history of severe chronic microvascular or macrovascular complications; (8) diseases that may be exacerbated by exercise or impair exercise efciency, such as uncontrolled hypertension, hyperthyroidism, osteoarthritis or hypokalemia; (9) unable to use smart phones or wearable smart devices independently; (10) communication or motor dysfunction; (11) Patients with severe chronic diseases could not participate in the study.

Sponsors & Collaborators

• Sichuan Academy of Medical Sciences: lead

Study Sites (1)

Sichuan Provinvial People's HSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital（ SAMS&SPPH，Affiliated Hospital of UESTC）ospital

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Wanjing Chen, MPH(Master of Public Health)

CONTACT

0086 13980605563; 270746867@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

CN (1)