- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07676773
Evaluate the Effect of Remote Exercise Intervention on Blood Glucose Control and Physical Fitness in T2DM Patients
A 12 Weeks Clinical Trail to Evaluate the Effect of Remote Exercise Intervention on Blood Glucose Control and Physical Fitness in T2DM Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Wanjing Chen, MPH(Master of Public Health)
- Telefonnummer: 0086 13980605563
- E-post: 270746867@qq.com
Studieorter
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Sichuan
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Chengdu, Sichuan, Kina, 610000
- Rekrytering
- Sichuan Provinvial People's HSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital( SAMS&SPPH,Affiliated Hospital of UESTC)ospital
-
Kontakt:
- Yuhong Zeng
- Telefonnummer: 0086 13980605563
- E-post: clinicalresearchcenter@med.uestc.edu.cn
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
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Övrig: Education
Health education on DM and Exercise
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in glycemic control
Tidsram: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SichuanAMS-2023QN15
- 2023QN15 (Annat bidrag/finansieringsnummer: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital( SAMS&SPPH,Affiliated Hospital of UESTC))
Plan för individuella deltagardata (IPD)
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