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.
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kaohsiung, Taiwan, 831
- Yu-Hsuan Chien
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
keep their normal live style
Other Names:
|
|
Placebo Comparator: Control group
They are keep their normal live style
|
keep their normal live style
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c level
Time Frame: up to 12 week of invention
|
follow blood glucose control
|
up to 12 week of invention
|
|
muscle strength
Time Frame: up to 12 weeks of intervention
|
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
Time Frame: up to 12 weeks of invention
|
Use BIA(Bioelectrical impedance analysis)follow muscle mass,
|
up to 12 weeks of invention
|
|
5-time chair stand test
Time Frame: up to 12 weeks of invention
|
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
Time Frame: up to 12 week of invention
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Chia-Jen Tsai, Kaohsiung Chang Gung Medication Hosipital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202001276B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength
-
Princess Nourah Bint Abdulrahman UniversityCompletedMetabolic Syndrome | Blood Pressure | Oxidative Stress | Aerobic Exercise | Glycemic Control | Strength TrainingSaudi Arabia