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.

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

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647617
• Other study ID #: 202001276B0
• Status: Completed
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Sarcopenia
• Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength

Intervention

Behavioral:
• Quantitative weight -bearing and report exercise sign data every weekly
keep their normal live style

Locations

Country	Name	City	State
Taiwan	Yu-Hsuan Chien	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Yu- Hsuan Chien

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c level	follow blood glucose control	up to 12 week of invention
Primary	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
Primary	muscle mass	Use BIA(Bioelectrical impedance analysis)follow muscle mass,	up to 12 weeks of invention
Primary	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	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