Effects of 12- Weeks of Quantitative Weight-bearing Progressive Resistance Exercise Training on Glycemia Control and Improving Muscle Strength With Type 2 Diabetes Combine Pre-sarcopenia.

Study Overview
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Brief Summary
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According to the International Diabetes Federation (IDF) in 2017 investigator found that the incidence of type 2 diabetes is currently 425 million people aged 20 to 79 in the world, and this data will increase o 629 million at 2045, The etiology of more than 90% is related to aging, it has become a serious challenge to public health. Sarcopenia is a newly noticed severe syndrome characterized by reduced walking speed, decreased grip strength, and decreased muscle mass. Patients with type 2 diabetes are at risk of sarcopenia and are those with normal blood sugar. One of the main ways to improve the face of sarcopenia is to exercise intensity. By carrying out a gradual training plan instead of using different weights, it will lead to muscle hypertrophy and increase in muscle strength to achieve muscle gain. In view of the fact that the commercially available sandbags are cheap and easy to obtain, the weight is fixed, and the use variability is high, it is expected to introduce quantitative weight-bearing progressive exercises in type 2 diabetes and have symptoms of muscle loss to improve muscle mass, and to control blood sugar. The quality of life can have better benefits.

Detailed Description
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Purpose:This study aim is effectiveness of 12 weeks quantitative weight-bearing progressive exercise training in patients with type 2 diabetes mellitus(T2DM) with pre-sarcopenia promotion muscle strength and blood sugar control. Hypothesis:After 12 weeks of quantitative sandbag training , the experimental group can have a significant increase in the muscle mass of the upper and lower limbs、grip strength、5-time chair stand test、Lipid profile、glycemic control(HbA1c) and quality of life. Methods:This study will be a randomized controlled trial. Forty adult diagnosis with T2DM with pre-sarcopenia patient randomly assigned to experimental group and control group. Experimental group wearing 0.5 kg quantitative sandbag 12 15 Repetitions/set X 5 set X 3day. Weight adjustment: After the first month of intervention, if the experimental can perform for more than 20 repetitions/set , we will asked to increase the weight of the sandbag to 1 kg until the end of the experiment Conditions:The effectiveness of 12 weeks quantitative weight-bearing can improvement of Glycemic control and limb muscle strength.

Official Title
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Effects of 12- Weeks of Quantitative Weight-bearing Progressive Resistance Exercise Training on Glycemia Control and Improving Muscle Strength With Type 2 Diabetes Combine Pre-sarcopenia.

Conditions
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Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength

Intervention / Treatment
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* Behavioral: Quantitative weight -bearing and report exercise sign data every weekly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 50  80 years T2DM Physician and check Calf circumference (M: <34 cm, F: <33 cm)、handgrip strength (M: <28 kg, F: <18 kg) Exclusion Criteria: Inability to perform any self -activity DM with lower limb neuropathy, r DM with Retinopathy Stroke Foot opening wound Past history even doing limb resistance training; Easy fall down high risk patients

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Forty adult diagnosis with T2DM with pre-sarcopenia patient randomly assigned to experimental group and control group. Experimental group wearing 0.5 kg quantitative sandbag 12 15 Repetitions/set X 5 set X 3day.control group keep normal lives
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quantitative Weight-bearing<br>Experimental wearing 0.5 kg quantitative sandbag 12 15 Repetitions/set X 5 set X 3day. Weight adjustment: After the first month of intervention, if the experimental can perform for more than 20 repetitions/set , we will asked to increase the weight of the sandbag to 1 kg until the end of the experiment | Behavioral: Quantitative weight -bearing and report exercise sign data every weekly<br>* keep their normal live style<br>* Other names: Self-manage;|
| Placebo Comparator: Control group<br>They are keep their normal live style | Behavioral: Quantitative weight -bearing and report exercise sign data every weekly<br>* keep their normal live style<br>* Other names: Self-manage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c level | follow blood glucose control | up to 12 week of invention | 
| muscle strength | follow hand grip male.If the hand grip show weakness it mean the worse of muscle strength | up to 12 weeks of intervention | 
| muscle mass | Use BIA(Bioelectrical impedance analysis)follow muscle mass, | up to 12 weeks of invention | 
| 5-time chair stand test | follow low limb muscle strength .The higher number of seconds, it mean the worse the lower limb ability | up to 12 weeks of invention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHOQOL-BREF World Health Organization Quality of Life Taiwan version | follow T2DM with pre-sarcopenia quality of life. The Questionnaire include four domain: psychological domain, social domain, environment domain and Taiwan local domain.This questionnaire scale higher is more better follow T2DM with pre-sarcopenia | up to 12 week of invention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistance training；Muscle strength；Glycemic control