The establishment of a reference standard value for lower-extremity strength in patients with type 2 diabetes to clinically evaluate both the degree of diabetic complications and the effectiveness of exercise therapy

The establishment of a reference standard value for lower-extremity strength in patients with type 2 diabetes to clinically evaluate both the degree of diabetic complications and the effectiveness of exercise therapy - Multicenter survey of the isometric lower-extremity strength in type 2 diabetes (MUSCLE-std)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000002810

Enrollment

1200

Registered

2009-11-30

Start date

2010-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Type 2 diabetes mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inpatients and/or outpatients with type 2 diabetes, who give written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who could not adapt to the exercise therapy. 2. Independent walking is impossible. 3. Significant limitations in their activities of daily of living. 4. Severe heart and/or respiratory diseases. 5. Severe liver dysfunction and/or renal failure (serum creatinine over 2.0 mg/dL). 6. Patients having acute and/or chronic orthopedic disease, and who were presently receiving medical treatment. 7. Patients having non-symmetry of bilateral lower-extremity muscular atrophy. 8. Patients having an impairment of the lower-extremities. 9. Patients having severe infectious disease. 10. Patients requiring surgical treatment. 11. Other conditions that resulted in the patients being considered to be ineligible by the researcher.

Design outcomes

Primary

Measure	Time frame
Knee extension force	—

Secondary

Measure	Time frame
1. Characteristics: body weight, length of lower leg, height, age, and a non-dominant leg. 2. Diabetes treatment-related information: Duration of diabetes, fasting plasma glucose (or postprandial plasma glucose), HbA1c, LDL cholesterol, HDL cholesterol, total cholesterol, trygriceride, serum creatinine, fasting insulin, the administration of diet therapy and the details of such diet therapy, the use of drug therapy and the details of drug therapy. 3. Diabetic polyneuropathy by a simple diagnosis standard neuropathy test: achilles' tendon reflex, vibratory sense on medial malleolus, subjective symptoms. 4. Complications associated with diabetes, complications not related to diabetes. 5. Clarify and evaluate the patient's normal exercise patterns, drinking habit, and smoking habit.	—

Measure

Time frame

1. Characteristics: body weight, length of lower leg, height, age, and a non-dominant leg. 2. Diabetes treatment-related information: Duration of diabetes, fasting plasma glucose (or postprandial plasma glucose), HbA1c, LDL cholesterol, HDL cholesterol, total cholesterol, trygriceride, serum creatinine, fasting insulin, the administration of diet therapy and the details of such diet therapy, the use of drug therapy and the details of drug therapy. 3. Diabetic polyneuropathy by a simple diagnosis standard neuropathy test: achilles' tendon reflex, vibratory sense on medial malleolus, subjective symptoms. 4. Complications associated with diabetes, complications not related to diabetes. 5. Clarify and evaluate the patient's normal exercise patterns, drinking habit, and smoking habit.

—

Countries

Japan

Contacts

Public ContactTakuo Nomura

Kansai University of Welfare Sciences Department of Rehabilitation Sciences, Faculty of Allied Health Sciences

tnomura@tamateyama.ac.jp072-978-0088

Outcome results