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

24 de junio de 2026 actualizado por: Sichuan Academy of Medical Sciences

A 12 Weeks Clinical Trail to Evaluate the Effect of Remote Exercise Intervention on Blood Glucose Control and Physical Fitness in T2DM Patients

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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Wanjing Chen, MPH(Master of Public Health)
  • Número de teléfono: 0086 13980605563
  • Correo electrónico: 270746867@qq.com

Ubicaciones de estudio

    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610000
        • Reclutamiento
        • Sichuan Provinvial People's HSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital( SAMS&SPPH,Affiliated Hospital of UESTC)ospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Remote Exercise Management
Participants receive 12-week personalized remote exercise intervention (aerobic + resistance) based on FITT-VP principles, monitored via wearable devices, along with standard health education.
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).
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.
Otro: Education
Health education on DM and Exercise
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in glycemic control
Periodo de tiempo: Baseline and 12 weeks
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2026

Finalización primaria (Estimado)

31 de agosto de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de junio de 2026

Publicado por primera vez (Actual)

30 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • SichuanAMS-2023QN15
  • 2023QN15 (Otro número de subvención/financiamiento: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital( SAMS&SPPH,Affiliated Hospital of UESTC))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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