Study on the effect of the original exercise program on muscle strength, muscle mass, and metabolic parameters

JRCT ID: jRCT1050210193

Registered date:14/03/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Type2 diabetes
• Date of first enrollment: 14/03/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Participating patients perform the exercise therapy program (aerobic and resistance exercise), as follows. Aerobic exercise: 3-5 days or more per week (without 2 days interval), totaly more than 10 kcal/kg/week (equivalent to 4METs x 2.5 hours). Resistance exercise: consisted of core-menus (trunk and lower limb training) and sub-menus (upper limb and chest training) which are set to low, medium, and high intensity, 2 to 3 days per week (non-consecutive days).

Outcome(s)

Primary Outcome

Plasma hypoxanthine (HX), xanthine (Xan), uric acid (UA), and xanthine oxidoreductase (XOR) activity before and after WBV exercise
Body composition evaluated by In Body, grip strength,lower limb extension, and thigh circumference

Secondary Outcome

International Physical Activity Questionnaires(IPAQ)
Eating behavior questionnaire
Food preference questionnaire
Exercise function test such as chair-stand test and 6-minute walking distance

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 74age old
• Gender: Both

Include criteria

Type 2 diabetic patients admitted to the Department of Diabetes, Endocrinology, and Metabolism, Osaka University Hospital (regardless of gender), who meet the following criteria
1) Patients aged 20 to 74 years
2) Patients diagnosed with type 2 diabetes by the doctors
3) Patients who have agreed to participate in the program

Exclude criteria

1) Patients with type 1 diabetes or secondary diabetes
2) Fasting plasma glucose; 250mg/dl or more
3) Resting blood pressure; 180/110mmHg or more
4) Diabetic nephropathy with stage 3 or more (urinary albumin/creatinine ratio; 300 mg/g Cr or more or persistent proteinuria)
5) Severe neuropathy (sensory and autonomic neuropathy)
6) Unstable diabetic retinopathy such as preproliferative or proliferative retinopathy
7) Unstable macroangiopathy such as cardiovascular disease and peripheral arterial disease
8) Severe liver damage (decompensated cirrhosis, etc.)
9) Heart failure (NYHA; II or more or patients on limited physical activity)
10) Patients at high risk of hypoglycemia
11) Patients whose condition is thought to worsen by whole body vibration (e.g. dizziness, etc.)
12) Patients who are at risk of falling and are judged to have difficulty in performing whole body vibration
13) Female patients who are pregnant or potentially pregnant and are lactating
14) Patients who are judged by the doctors to be inappropriate for participation in the program due to complications (e.g. blindness, decreased ADL, scheduled surgery, uncontrollable active infections, etc.)
15) Patients who are difficult for the doctors to assess the effectiveness of the program (e.g. complications of psychiatric disorders or mental disorders, having difficulty in communicating with medical staff, alcohol-dependent / drug-dependent, planning a long trip during the program, opposed by their families, and a rapid weight loss more than 4.5 kg within 3 months, etc.)
16) Patients that the primary investigator or the doctors consider to be inappropriate for other reasons

Related Information

• Primary Sponsor: Nishizawa Hitoshi