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.
Primary Purpose
Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Quantitative weight -bearing and report exercise sign data every weekly
Sponsored by
About this trial
This is an interventional other trial for Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength focused on measuring Resistance training;Muscle strength;Glycemic control
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
Sites / Locations
- Yu-Hsuan Chien
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Quantitative Weight-bearing
Control group
Arm Description
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
They are keep their normal live style
Outcomes
Primary Outcome Measures
HbA1c level
follow blood glucose control
muscle strength
follow hand grip male.If the hand grip show weakness it mean the worse of muscle strength
muscle mass
Use BIA(Bioelectrical impedance analysis)follow muscle mass,
5-time chair stand test
follow low limb muscle strength .The higher number of seconds, it mean the worse the lower limb ability
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04647617
Brief 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.
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yu- Hsuan Chien
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength
Keywords
Resistance training;Muscle strength;Glycemic control
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
single
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quantitative Weight-bearing
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
They are keep their normal live style
Intervention Type
Behavioral
Intervention Name(s)
Quantitative weight -bearing and report exercise sign data every weekly
Other Intervention Name(s)
Self-manage
Intervention Description
keep their normal live style
Primary Outcome Measure Information:
Title
HbA1c level
Description
follow blood glucose control
Time Frame
up to 12 week of invention
Title
muscle strength
Description
follow hand grip male.If the hand grip show weakness it mean the worse of muscle strength
Time Frame
up to 12 weeks of intervention
Title
muscle mass
Description
Use BIA(Bioelectrical impedance analysis)follow muscle mass,
Time Frame
up to 12 weeks of invention
Title
5-time chair stand test
Description
follow low limb muscle strength .The higher number of seconds, it mean the worse the lower limb ability
Time Frame
up to 12 weeks of invention
Secondary Outcome Measure Information:
Title
WHOQOL-BREF World Health Organization Quality of Life Taiwan version
Description
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
Time Frame
up to 12 week of invention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Jen Tsai
Organizational Affiliation
Kaohsiung Chang Gung Medication Hosipital
Official's Role
Study Director
Facility Information:
Facility Name
Yu-Hsuan Chien
City
Kaohsiung
ZIP/Postal Code
831
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently in the submission stage, and then share with other researchers after publication
Learn more about this trial
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.
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