Type 2 diabetes mellitus
Conditions
Interventions
Outpatient physical therapy is provided every 4 weeks for 24 weeks in addition to oral guidance using exercise materials.
Exercise materials is distributed at the first session, and no exercise instru
Sponsors
Shijonawate Gakuen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients with type 2 diabetes 2. Diabetes duration: at least 24 weeks 3. HbA1c: between 7.0% and 10.0% 4. Body mass index (BMI): between 22.0 and 35.0
Exclusion criteria
Exclusion criteria: 1. Patients who have been already receiving regular exercise instruction from physical therapists 2. Patients who already have sufficient amount of exercise (for at least 30 minutes per session and at least twice a week / resistance exercise at least twice a week) 3. Patients who have been receiving insulin therapy or plan to introduce insulin therapy during the period 4. Patients who have changed their medication or diet within 3 months prior to the start of observation, or who are scheduled to change their medication or diet during the period 5. Patients with large fluctuations in HbA1c or body weight (HbA1c: plus or minus 0.5% or more, body weight: plus or minus 3 kg or more) within 3 months prior to the start of observation 6. Patients within 4 weeks of discharge from diabetes education hospitalization 7. Patients with advanced diabetic complications (retinopathy except simple retinopathy, nephropathy stage IV or later, severe neuropathy or foot involvement) 8. Patients with a fasting blood glucose level of 250 mg/dL or higher and a urine ketone level moderately positive or higher at screening 9. Patients with severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg in the resting sitting position) 10. Patients who are considered to have difficulty with active exercise load due to concomitant or pre-existing cerebrovascular, cardiovascular, respiratory, or locomotor diseases 11. Patients with acute or severe infections 12. Patients with concomitant or pre-existing malignancy (but may be included if they have not required treatment for at least the past 5 years and have no evidence of recurrence) 13. Patients who are deemed to be cognitively impaired and unable to perform the study 14. Patients who are certified as needed support or needed long-term care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Term for evaluation At baseline, at 12 weeks, and at 24 weeks Evaluation items HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Term for evaluation At baseline, at 12 weeks, and at 24 weeks Evaluation items Physical function (grip strength, knee extensor strength, five times sit-to-stand test, walking speed) Urinalysis data (urinary Alb, eGFR, urinary Cr) Physical activity (number of steps, energy expenditure, moderate-to-vigorous intensity physical activity) | — |
Countries
Japan
Contacts
Public ContactHiroto Honda
Shijonawate Gakuen University Faculty of Rehabilitation
Outcome results
None listed