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.

NCT ID: NCT04647617

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-24

Study Completion Date

2020-12-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
single

Study Groups

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Quantitative Weight-bearing

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

Group Type EXPERIMENTAL

Quantitative weight -bearing and report exercise sign data every weekly

Intervention Type BEHAVIORAL

keep their normal live style

Control group

They are keep their normal live style

Group Type PLACEBO_COMPARATOR

Quantitative weight -bearing and report exercise sign data every weekly

Intervention Type BEHAVIORAL

keep their normal live style

Interventions

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Quantitative weight -bearing and report exercise sign data every weekly

keep their normal live style

Intervention Type BEHAVIORAL

Other Intervention Names

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Self-manage

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yu- Hsuan Chien

OTHER

Sponsor Role lead

Responsible Party

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Yu- Hsuan Chien

Chang Gung Memorial Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chia-Jen Tsai

Role: STUDY_DIRECTOR

Kaohsiung Chang Gung Medication Hosipital

Locations

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Yu-Hsuan Chien

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202001276B0

Identifier Type: -

Identifier Source: org_study_id

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