Clinical trial NCT04647617: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength
Keywords: Resistance training；Muscle strength；Glycemic control
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c level
timeFrame: up to 12 week of invention
measure: muscle strength
timeFrame: up to 12 weeks of intervention
measure: muscle mass
timeFrame: up to 12 weeks of invention
measure: 5-time chair stand test
timeFrame: up to 12 weeks of invention
Secondary outcomes:
measure: WHOQOL-BREF World Health Organization Quality of Life Taiwan version
timeFrame: up to 12 week of invention
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Yu-Hsuan Chien
Study officials:
affiliation: Kaohsiung Chang Gung Medication Hosipital
name: Chia-Jen Tsai
role: STUDY_DIRECTOR
References: